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Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors

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ClinicalTrials.gov Identifier: NCT02564900
Recruitment Status : Completed
First Posted : October 1, 2015
Results First Posted : June 23, 2021
Last Update Posted : January 22, 2024
Sponsor:
Collaborators:
Daiichi Sankyo
AstraZeneca
Information provided by (Responsible Party):
Daiichi Sankyo ( Daiichi Sankyo Co., Ltd. )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Solid Tumors
Interventions Drug: DS-8201a (DP1)
Drug: DS-8201a (DP2)
Drug: DS-8201a (DP)
Enrollment 292
Recruitment Details A total of 292 participants who met all inclusion and no exclusion criteria were enrolled at 8 centers in the US and 6 centers in Japan. A total of 27 participants started the Dose Escalation phase and a total of 265 participants in the Dose Expansion phase.
Pre-assignment Details The Dose Escalation was intended to identify the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of DS-8201a with at least 3 participants evaluable for assessment of dose-limiting toxicity per dose level. Since the MTD was not reached, doses of 5.4 mg/kg and 6.4 mg/kg were chosen for evaluation in the Dose Expansion phase.
Arm/Group Title Dose Escalation: Cohort 1, 0.8 mg/kg Dose Escalation: Cohort 2, 1.6 mg/kg Dose Escalation: Cohort 3, 3.2 mg/kg Dose Escalation: Cohort 4, 5.4 mg/kg Dose Escalation: Cohort 5, 6.4 mg/kg Dose Escalation: Cohort 6, 8.0 mg/kg Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg Dose Expansion: HER2-expressing NSCLC Tumors Dose Expansion: HER2-expressing Colorectal Tumors Dose Expansion: HER2-expressing Other Solid Tumors
Hide Arm/Group Description Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1). Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1). Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1). Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1). Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1). Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1). Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Period Title: Dose Escalation
Started 3 3 3 6 6 6 0 0 0 0 0 0 0 0 0
Completed [1] 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Not Completed 3 3 3 6 6 6 0 0 0 0 0 0 0 0 0
Reason Not Completed
Progressive disease per RECIST             2             3             3             3             3             1             0             0             0             0             0             0             0             0             0
Ongoing             1             0             0             2             2             2             0             0             0             0             0             0             0             0             0
Adverse Event             0             0             0             1             1             3             0             0             0             0             0             0             0             0             0
[1]
Data from Ongoing and Discontinued participants are presented as of data cutoff on 01 February 2019
Period Title: Dose Expansion
Started [1] 0 0 0 0 0 0 49 62 20 33 17 24 18 20 22
Enrolled, But Not Dosed 0 0 0 0 0 0 1 1 0 0 0 0 0 0 1
Completed [2] 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 49 62 20 33 17 24 18 20 22
Reason Not Completed
Progressive disease per RECIST             0             0             0             0             0             0             19             17             8             16             13             19             10             13             11
Clinical progression             0             0             0             0             0             0             5             12             0             3             2             0             1             3             1
Adverse Event             0             0             0             0             0             0             9             22             0             11             0             5             2             2             1
Ongoing             0             0             0             0             0             0             9             10             11             3             0             0             4             0             6
Death             0             0             0             0             0             0             1             0             0             0             1             0             1             1             0
Withdrawal by Subject             0             0             0             0             0             0             4             0             0             0             1             0             0             1             1
Other             0             0             0             0             0             0             1             0             1             0             0             0             0             0             1
Did not receive treatment             0             0             0             0             0             0             1             1             0             0             0             0             0             0             1
[1]
Only the Dose Expansion Phase is being presented.
[2]
Data from Ongoing and Discontinued participants are presented as of data cutoff on 01 February 2019.
Arm/Group Title Dose Escalation: Cohort 1, 0.8 mg/kg Dose Escalation: Cohort 2, 1.6 mg/kg Dose Escalation: Cohort 3, 3.2 mg/kg Dose Escalation: Cohort 4, 5.4 mg/kg Dose Escalation: Cohort 5, 6.4 mg/kg Dose Escalation: Cohort 6, 8.0 mg/kg Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg Dose Expansion: HER2-expressing NSCLC Tumors Dose Expansion: HER2-expressing Colorectal Tumors Dose Expansion: HER2-expressing Other Solid Tumors Total
Hide Arm/Group Description Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1). Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1). Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1). Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1). Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1). Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1). Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1). Total of all reporting groups
Overall Number of Baseline Participants 3 3 3 6 6 6 49 62 20 33 17 24 18 20 22 292
Hide Baseline Analysis Population Description
Demographic and baseline characteristics were assessed in the Enrolled Analysis Set (Dose Escalation, n=27; Dose Expansion, n=265).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 6 participants 49 participants 62 participants 20 participants 33 participants 17 participants 24 participants 18 participants 20 participants 22 participants 292 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  66.7%
1
  33.3%
2
  66.7%
2
  33.3%
4
  66.7%
2
  33.3%
33
  67.3%
48
  77.4%
14
  70.0%
25
  75.8%
6
  35.3%
8
  33.3%
12
  66.7%
16
  80.0%
16
  72.7%
191
  65.4%
>=65 years
1
  33.3%
2
  66.7%
1
  33.3%
4
  66.7%
2
  33.3%
4
  66.7%
16
  32.7%
14
  22.6%
6
  30.0%
8
  24.2%
11
  64.7%
16
  66.7%
6
  33.3%
4
  20.0%
6
  27.3%
101
  34.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 6 participants 49 participants 62 participants 20 participants 33 participants 17 participants 24 participants 18 participants 20 participants 22 participants 292 participants
59.3  (7.09) 66.3  (4.73) 48.3  (14.57) 66.8  (14.82) 58.2  (10.40) 66.2  (10.67) 56.2  (12.11) 54.9  (10.28) 57.8  (9.68) 56.3  (10.97) 64.2  (11.00) 66.2  (8.55) 57.4  (15.29) 59.5  (9.90) 58.5  (10.16) 58.1  (11.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 6 participants 49 participants 62 participants 20 participants 33 participants 17 participants 24 participants 18 participants 20 participants 22 participants 292 participants
Female
3
 100.0%
3
 100.0%
3
 100.0%
6
 100.0%
6
 100.0%
5
  83.3%
48
  98.0%
62
 100.0%
20
 100.0%
33
 100.0%
5
  29.4%
4
  16.7%
13
  72.2%
9
  45.0%
9
  40.9%
229
  78.4%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
12
  70.6%
20
  83.3%
5
  27.8%
11
  55.0%
13
  59.1%
63
  21.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 6 participants 49 participants 62 participants 20 participants 33 participants 17 participants 24 participants 18 participants 20 participants 22 participants 292 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.3%
Asian
3
 100.0%
3
 100.0%
3
 100.0%
6
 100.0%
6
 100.0%
3
  50.0%
25
  51.0%
40
  64.5%
6
  30.0%
23
  69.7%
11
  64.7%
24
 100.0%
9
  50.0%
17
  85.0%
14
  63.6%
193
  66.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.3%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
   6.1%
2
   3.2%
1
   5.0%
1
   3.0%
0
   0.0%
0
   0.0%
1
   5.6%
0
   0.0%
0
   0.0%
8
   2.7%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  50.0%
19
  38.8%
19
  30.6%
12
  60.0%
7
  21.2%
5
  29.4%
0
   0.0%
8
  44.4%
3
  15.0%
7
  31.8%
83
  28.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.0%
1
   5.9%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
1
   5.0%
1
   3.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.5%
4
   1.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 6 participants 49 participants 62 participants 20 participants 33 participants 17 participants 24 participants 18 participants 20 participants 22 participants 292 participants
United States 0 0 0 0 0 3 30 25 16 11 5 0 10 3 9 112
Japan 3 3 3 6 6 3 19 37 4 22 12 24 8 17 13 180
1.Primary Outcome
Title Objective Response Rate (ORR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
Hide Description Objective response rate (ORR) by independent central review was defined as the proportion of participants who achieve either complete response [CR] or partial response [PR] per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.
Time Frame From 6 months postdose of last participant up to 3 years 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
ORR was assessed among participants in the Intent-to-Treat Analysis Set.
Arm/Group Title Dose Escalation: Cohort 1, 0.8 mg/kg Dose Escalation: Cohort 2, 1.6 mg/kg Dose Escalation: Cohort 3, 3.2 mg/kg Dose Escalation: Cohort 4, 5.4 mg/kg Dose Escalation: Cohort 5, 6.4 mg/kg Dose Escalation: Cohort 6, 8.0 mg/kg Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg Dose Expansion: HER2-expressing NSCLC Tumors Dose Expansion: HER2-expressing Colorectal Tumors Dose Expansion: HER2-expressing Other Solid Tumors
Hide Arm/Group Description:
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Overall Number of Participants Analyzed 3 3 3 6 6 6 51 67 21 33 19 25 18 20 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 70.8)
33.3
(0.8 to 90.6)
0
(0 to 70.8)
83.3
(35.9 to 99.6)
33.3
(4.3 to 77.7)
50.0
(11.8 to 88.2)
51.0
(36.6 to 65.2)
53.7
(41.1 to 66.0)
33.3
(14.6 to 57.0)
39.4
(22.9 to 57.9)
26.3
(9.1 to 51.2)
32.0
(14.9 to 53.5)
55.6
(30.8 to 78.5)
5.0
(0.1 to 24.9)
30.4
(13.2 to 52.9)
2.Secondary Outcome
Title Disease Control Rate (DCR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
Hide Description Disease control rate (DCR) by independent central review was calculated as the proportion of participants demonstrating complete response (CR), partial response (PR), or stable disease (SD) for a minimum of 6 weeks (±1week) from the first dosing date. CR was defined as a disappearance of all target lesions, PR as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included 8 participants with salivary/submandibular/parotid gland, 2 breast with HER2-mutation, 2 endometrial, 2 esophageal, 2 Paget's disease, 1 cholangiocarcinoma, 1 extraskeletal myxoide chondrosarcoma, 1 gallbladder, 1 pancreatic, 1 small intestine, 1 uterine cervix, and 1 participant who received 5.4 mg/kg with HER2-low gastric/GEJ cancer.
Time Frame From 6 months postdose of last participant up to 3 years 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
DCR was assessed in the Intent-to-Treat Analysis Set.
Arm/Group Title Dose Escalation: Cohort 1, 0.8 mg/kg Dose Escalation: Cohort 2, 1.6 mg/kg Dose Escalation: Cohort 3, 3.2 mg/kg Dose Escalation: Cohort 4, 5.4 mg/kg Dose Escalation: Cohort 5, 6.4 mg/kg Dose Escalation: Cohort 6, 8.0 mg/kg Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg Dose Expansion: HER2-expressing NSCLC Tumors Dose Expansion: HER2-expressing Colorectal Tumors Dose Expansion: HER2-expressing Other Solid Tumors
Hide Arm/Group Description:
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Overall Number of Participants Analyzed 3 3 3 6 6 6 51 67 21 33 19 25 18 20 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(29.2 to 100.0)
100.0
(29.2 to 100.0)
66.7
(9.4 to 99.2)
100.0
(54.1 to 100.0)
100.0
(54.1 to 100.0)
100.0
(54.1 to 100.0)
88.2
(76.1 to 95.6)
95.5
(87.5 to 99.1)
85.7
(63.7 to 97.0)
87.9
(71.8 to 96.6)
78.9
(54.4 to 93.9)
88.0
(68.8 to 97.5)
83.3
(58.6 to 96.4)
80.0
(56.3 to 94.3)
82.6
(61.2 to 95.0)
3.Secondary Outcome
Title Best Overall Response Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
Hide Description Best overall response by independent central review was defined as the proportion of participants who achieved either complete response [CR], partial response [PR], stable disease (SD), progressive disease (PD), or were non-evaluable (NE) as per RECIST v1.1. CR was defined as a disappearance of all target lesions, PR at least a 30% decrease in the sum of diameters of target lesions, and SD as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD defined as at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included 8 participants with salivary/submandibular/parotid gland, 2 breast with HER2-mutation, 2 endometrial, 2 esophageal, 2 Paget's disease, 1 cholangiocarcinoma, 1 extraskeletal myxoide chondrosarcoma, 1 gallbladder, 1 pancreatic, 1 small intestine, 1 uterine cervix, and 1 participant who received 5.4 mg/kg with HER2-low gastric/GEJ cancer.
Time Frame From 6 months postdose of last participant up to 3 years 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
Best overall response was assessed in the Intent-to-Treat Analysis Set.
Arm/Group Title Dose Escalation: Cohort 1, 0.8 mg/kg Dose Escalation: Cohort 2, 1.6 mg/kg Dose Escalation: Cohort 3, 3.2 mg/kg Dose Escalation: Cohort 4, 5.4 mg/kg Dose Escalation: Cohort 5, 6.4 mg/kg Dose Escalation: Cohort 6, 8.0 mg/kg Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg Dose Expansion: HER2-expressing NSCLC Tumors Dose Expansion: HER2-expressing Colorectal Tumors Dose Expansion: HER2-expressing Other Solid Tumors
Hide Arm/Group Description:
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Overall Number of Participants Analyzed 3 3 3 6 6 6 51 67 21 33 19 25 18 20 23
Measure Type: Count of Participants
Unit of Measure: Participants
Complete response
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
1
  16.7%
0
   0.0%
2
   3.9%
8
  11.9%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.0%
0
   0.0%
0
   0.0%
2
   8.7%
Partial response
0
   0.0%
1
  33.3%
0
   0.0%
4
  66.7%
1
  16.7%
3
  50.0%
24
  47.1%
28
  41.8%
7
  33.3%
13
  39.4%
5
  26.3%
7
  28.0%
10
  55.6%
1
   5.0%
5
  21.7%
Stable disease
3
 100.0%
2
  66.7%
2
  66.7%
1
  16.7%
4
  66.7%
3
  50.0%
19
  37.3%
28
  41.8%
11
  52.4%
16
  48.5%
10
  52.6%
14
  56.0%
5
  27.8%
15
  75.0%
12
  52.2%
Progressive disease
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
4
   7.8%
1
   1.5%
3
  14.3%
3
   9.1%
4
  21.1%
3
  12.0%
2
  11.1%
2
  10.0%
3
  13.0%
Non-evaluable
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   3.9%
2
   3.0%
0
   0.0%
1
   3.0%
0
   0.0%
0
   0.0%
1
   5.6%
2
  10.0%
1
   4.3%
4.Secondary Outcome
Title Duration of Response (DoR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)
Hide Description Duration of response (DoR) by independent central review was defined as the time between the date of the first complete response (CR) or partial response (PR) until the date of the first documentation of progressive disease (PD) or death due to any cause. CR was defined as a disappearance of all target lesions, PR as at least a 30% decrease in the sum of diameters of target lesions, and PD as at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.
Time Frame From 6 months postdose of last participant up to 3 years 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
DoR was assessed among participants who achieved a CR or PR in the Intent-to-Treat Analysis Set.
Arm/Group Title Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg Dose Expansion: HER2-expressing NSCLC Tumors Dose Expansion: HER2-expressing Colorectal Tumors Dose Expansion: HER2-expressing Other Solid Tumors
Hide Arm/Group Description:
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Overall Number of Participants Analyzed 51 67 21 33 19 25 18 20 23
Median (95% Confidence Interval)
Unit of Measure: months
12.7 [1] 
(6.7 to NA)
13.6 [1] 
(7.3 to NA)
NA [2] 
(NA to NA)
10.4 [1] 
(3.4 to NA)
5.6 [1] 
(2.9 to NA)
6.9 [1] 
(3.5 to NA)
10.7
(6.9 to 11.5)
13.4 [1] 
(NA to NA)
NA [3] 
(3.0 to NA)
[1]
Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
[2]
Lack of a median value is due to less than 50% of the participants experiencing the event. In a Kaplan-Meier analysis, the curve would never fall below the 50% mark, and would continue to the largest observed censored time value.
[3]
Median and 95% confidence interval were not calculable due to insufficient number of participants with events.
5.Secondary Outcome
Title Time to Response (TTR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)
Hide Description Time to response (TTR) by independent central review was defined as the time interval between the date of registration until the date at which the criteria were first met for complete response (CR) or partial response (PR). Only participants who achieved CR or PR were included in the TTR analysis. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.
Time Frame From 6 months postdose of last participant up to 3 years 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
Time to response was assessed among participants who achieved CR or PR in the Intent-to-Treat Analysis Set.
Arm/Group Title Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg Dose Expansion: HER2-expressing NSCLC Tumors Dose Expansion: HER2-expressing Colorectal Tumors Dose Expansion: HER2-expressing Other Solid Tumors
Hide Arm/Group Description:
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Overall Number of Participants Analyzed 51 67 21 33 19 25 18 20 23
Median (95% Confidence Interval)
Unit of Measure: months
2.7
(1.5 to 2.9)
2.8
(1.4 to 2.9)
2.6
(1.2 to 4.2)
2.7
(1.2 to 3.1)
1.6
(1.2 to 3.1)
2.2
(1.4 to 2.9)
1.4
(1.2 to 2.8)
3.0 [1] 
(NA to NA)
1.6
(1.2 to 2.9)
[1]
The 95% confidence interval was not calculable due to insufficient number of participants with events.
6.Secondary Outcome
Title Progression-free Survival Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)
Hide Description Progression-free survival (PFS) by independent central review was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.
Time Frame From 6 months postdose of last participant up to 3 years 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
PFS was assessed in the Intent-to-Treat Analysis Set.
Arm/Group Title Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg Dose Expansion: HER2-expressing NSCLC Tumors Dose Expansion: HER2-expressing Colorectal Tumors Dose Expansion: HER2-expressing Other Solid Tumors
Hide Arm/Group Description:
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Overall Number of Participants Analyzed 51 67 21 33 19 25 18 20 23
Median (95% Confidence Interval)
Unit of Measure: months
13.7
(8.5 to 19.6)
14.1 [1] 
(8.5 to NA)
NA [2] 
(2.7 to NA)
11.1 [1] 
(5.0 to NA)
4.3
(2.6 to 8.6)
8.2
(4.2 to 11.0)
11.3
(7.2 to 14.3)
4.0
(2.7 to 5.6)
11.0 [1] 
(2.8 to NA)
[1]
Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
[2]
Median and 95% confidence interval were not calculable due to insufficient number of participants with events.
7.Secondary Outcome
Title Overall Survival Among Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)
Hide Description Overall survival (OS) by independent central review was defined as the time interval from the date of enrollment to the date of death from any cause. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.
Time Frame From 6 months postdose of last participant up to 3 years 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
OS was assessed in the Intent-to-Treat Analysis Set.
Arm/Group Title Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg Dose Expansion: HER2-expressing NSCLC Tumors Dose Expansion: HER2-expressing Colorectal Tumors Dose Expansion: HER2-expressing Other Solid Tumors
Hide Arm/Group Description:
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Overall Number of Participants Analyzed 51 67 21 33 19 25 18 20 23
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [2] 
(26.4 to NA)
NA [1] 
(NA to NA)
19.7
(12.5 to 29.4)
18.9 [3] 
(5.7 to NA)
26.2 [3] 
(10.0 to NA)
NA [2] 
(17.3 to NA)
15.6 [3] 
(4.8 to NA)
23.4 [3] 
(9.7 to NA)
[1]
Lack of median value is due to less than 50% of the participants experiencing the event. In a Kaplan-Meier analysis, the curve would never fall below the 50% mark, and would continue to the largest observed censored time value.
[2]
Median and 95% confidence interval were not calculable due to insufficient number of participants with events.
[3]
Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
8.Secondary Outcome
Title Pharmacokinetic (PK) Analysis: Area Under the Concentration Versus Time Curve (AUC) of Serum DS-8201a Following First Dose
Hide Description The serum PK parameters of DS-8201a and its analytes for area under the concentration-versus-time curve from time 0 to the last quantifiable concentration as calculated by the linear-up log-down trapezoidal method (AUClast) and AUC from time 0 to infinity (AUCinf) elimination rate constant associated with the terminal phase were estimated using standard non-compartmental methods.
Time Frame Post first dose up to Day 147
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Arm/Group Title Dose Escalation: Cohort 1, 0.8 mg/kg Dose Escalation: Cohort 2, 1.6 mg/kg Dose Escalation: Cohort 3, 3.2 mg/kg Dose Escalation: Cohort 4, 5.4 mg/kg Dose Escalation: Cohort 5, 6.4 mg/kg Dose Escalation: Cohort 6, 8.0 mg/kg Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg Dose Expansion: HER2-expressing Other Solid Tumors Dose Expansion: HER2-expressing Breast Cancer
Hide Arm/Group Description:
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Japan only: Participants with HER2-expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP2).
Overall Number of Participants Analyzed 3 3 3 6 6 5 48 50 20 19 17 23 58 21
Mean (Standard Deviation)
Unit of Measure: ug*d/mL
AUClast Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 5 participants 48 participants 50 participants 20 participants 19 participants 17 participants 23 participants 58 participants 21 participants
51.7  (13.1) 116  (58.7) 325  (142) 544  (165) 901  (155) 996  (229) 559  (178) 785  (228) 581  (180) 693  (178) 542  (163) 507  (126) 631  (184) 693  (102)
AUCinfinity Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 5 participants 48 participants 49 participants 19 participants 17 participants 17 participants 22 participants 58 participants 21 participants
55.0  (11.9) 121  (58.9) 340  (150) 590  (186) 1030  (209) 1100  (259) 602  (203) 848  (243) 589  (145) 762  (205) 596  (183) 563  (151) 683  (209) 753  (118)
9.Secondary Outcome
Title Pharmacokinetic Analysis: Maximum (Peak) Observed Serum Concentration (Cmax) of Serum DS-8201a Following First Dose
Hide Description The serum PK parameters Maximum (peak) Observed serum concentration of DS-8201a and its analytes were estimated using standard non-compartmental method.
Time Frame Post first dose up to Day 147
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Arm/Group Title Dose Escalation: Cohort 1, 0.8 mg/kg Dose Escalation: Cohort 2, 1.6 mg/kg Dose Escalation: Cohort 3, 3.2 mg/kg Dose Escalation: Cohort 4, 5.4 mg/kg Dose Escalation: Cohort 5, 6.4 mg/kg Dose Escalation: Cohort 6, 8.0 mg/kg Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg Dose Expansion: HER2-expressing Other Solid Tumors Dose Expansion: HER2-expressing Breast Cancer
Hide Arm/Group Description:
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Japan only: Participants with HER2-expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP2).
Overall Number of Participants Analyzed 3 3 3 6 6 5 48 50 20 19 17 23 59 21
Mean (Standard Deviation)
Unit of Measure: ug/mL
22.9  (3.76) 36.2  (4.98) 78.2  (16.1) 127  (17.2) 181  (33.1) 221  (41.0) 126  (37.7) 170  (53.6) 133  (18.3) 155  (33.2) 113  (30.0) 116  (21.1) 150  (30.3) 155  (21.4)
10.Secondary Outcome
Title Pharmacokinetic Analysis: Time of Maximum Plasma Concentration (Tmax) of Serum DS-8201a Following First Dose
Hide Description The serum PK parameters of Time of maximum plasma concentration (Tmax) for DS-8201a and its analytes were estimated using standard non-compartmental methods.
Time Frame Post first dose up to Day 147
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Arm/Group Title Dose Escalation: Cohort 1, 0.8 mg/kg Dose Escalation: Cohort 2, 1.6 mg/kg Dose Escalation: Cohort 3, 3.2 mg/kg Dose Escalation: Cohort 4, 5.4 mg/kg Dose Escalation: Cohort 5, 6.4 mg/kg Dose Escalation: Cohort 6, 8.0 mg/kg Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg Dose Expansion: HER2-expressing Other Solid Tumors Dose Expansion: HER2-expressing Breast Cancer
Hide Arm/Group Description:
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Japan only: Participants with HER2-expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP2).
Overall Number of Participants Analyzed 3 3 3 6 6 5 48 50 20 19 17 23 59 21
Median (Full Range)
Unit of Measure: hours
1.95
(1.62 to 1.98)
4.03
(1.87 to 4.08)
4.12
(1.95 to 6.88)
2.02
(1.87 to 2.07)
2.06
(1.50 to 3.97)
1.97
(1.70 to 6.80)
2.00
(1.50 to 6.85)
2.08
(1.53 to 7.05)
2.16
(1.50 to 7.07)
2.00
(1.50 to 6.67)
2.03
(1.58 to 4.08)
1.95
(1.53 to 7.00)
2.02
(1.50 to 7.20)
2.05
(1.62 to 7.23)
11.Secondary Outcome
Title Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) of Serum DS-8201a Following First Dose
Hide Description The serum PK parameters of Terminal elimination half-life for DS-8201a and its analytes was estimated using standard non-compartmental methods.
Time Frame Post first dose up to Day 147
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
Arm/Group Title Dose Escalation: Cohort 1, 0.8 mg/kg Dose Escalation: Cohort 2, 1.6 mg/kg Dose Escalation: Cohort 3, 3.2 mg/kg Dose Escalation: Cohort 4, 5.4 mg/kg Dose Escalation: Cohort 5, 6.4 mg/kg Dose Escalation: Cohort 6, 8.0 mg/kg Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg Dose Expansion: HER2-expressing Other Solid Tumors Dose Expansion: HER2-expressing Breast Cancer
Hide Arm/Group Description:
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Japan only: Participants with HER2-expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP2).
Overall Number of Participants Analyzed 3 3 3 6 6 5 48 49 19 17 17 22 58 21
Mean (Standard Deviation)
Unit of Measure: days
2.18  (0.671) 3.07  (1.22) 4.23  (1.24) 6.03  (0.603) 7.33  (1.64) 6.44  (0.793) 5.52  (1.23) 6.00  (1.22) 5.28  (1.49) 5.79  (1.01) 6.18  (1.18) 5.90  (1.57) 5.61  (1.29) 5.46  (1.02)
12.Secondary Outcome
Title Overview of Treatment-emergent Adverse Events
Hide Description Treatment-emergent adverse events were graded by Common Terminology Criteria for Adverse Events, v4.03.
Time Frame Baseline up to 28 days after the last dose of study drug, up to 3 years 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety events were assessed in the Safety Analysis Set. It was prespecified in the protocol that single patients with unique tumor types would be combined into 1 group for the safety analysis. For the safety overview, TEAEs for HER2-expressing NSCLC, Colorectal, and Other Solid Tumors (excluding 1 HER2-low gastric cancer subject who received 5.4 mg/kg) were combined and reported together.
Arm/Group Title Dose Escalation: Cohort 1, 0.8 mg/kg Dose Escalation: Cohort 2, 1.6 mg/kg Dose Escalation: Cohort 3, 3.2 mg/kg Dose Escalation: Cohort 4, 5.4 mg/kg Dose Escalation: Cohort 5, 6.4 mg/kg Dose Escalation: Cohort 6, 8.0 mg/kg Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg Dose Expansion: HER2-expressing Other Solid Tumors
Hide Arm/Group Description:
Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
Overall Number of Participants Analyzed 3 3 3 6 6 6 50 66 21 33 19 25 59
Measure Type: Count of Participants
Unit of Measure: Participants
Treatment-emergent adverse events (TEAEs)
3
 100.0%
3
 100.0%
3
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
50
 100.0%
66
 100.0%
20
  95.2%
33
 100.0%
19
 100.0%
25
 100.0%
59
 100.0%
Drug-related TEAEs
3
 100.0%
2
  66.7%
2
  66.7%
6
 100.0%
6
 100.0%
6
 100.0%
50
 100.0%
66
 100.0%
20
  95.2%
33
 100.0%
18
  94.7%
25
 100.0%
59
 100.0%
TEAEs ≥Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
5
  83.3%
2
  33.3%
2
  33.3%
23
  46.0%
42
  63.6%
11
  52.4%
23
  69.7%
10
  52.6%
20
  80.0%
37
  62.7%
Drug-related TEAEs ≥Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
3
  50.0%
2
  33.3%
2
  33.3%
18
  36.0%
37
  56.1%
8
  38.1%
20
  60.6%
8
  42.1%
16
  64.0%
30
  50.8%
Serious TEAEs (including AEs ending in death)
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
1
  16.7%
1
  16.7%
11
  22.0%
17
  25.8%
3
  14.3%
12
  36.4%
4
  21.1%
7
  28.0%
18
  30.5%
Drug-related serious TEAEs
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
4
   8.0%
11
  16.7%
2
   9.5%
8
  24.2%
1
   5.3%
3
  12.0%
9
  15.3%
TEAEs associated with death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
   6.0%
1
   1.5%
0
   0.0%
2
   6.1%
0
   0.0%
1
   4.0%
5
   8.5%
Drug-related TEAEs associated with death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
1
   1.5%
0
   0.0%
2
   6.1%
0
   0.0%
0
   0.0%
2
   3.4%
TEAEs associated with discontinuation of drug
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
3
  50.0%
7
  14.0%
22
  33.3%
0
   0.0%
11
  33.3%
0
   0.0%
4
  16.0%
5
   8.5%
Related TEAEs associated with drug discontinuation
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
1
  16.7%
5
  10.0%
21
  31.8%
0
   0.0%
11
  33.3%
0
   0.0%
3
  12.0%
5
   8.5%
TEAEs associated with dose reduction
0
   0.0%
0
   0.0%
0
   0.0%
2
  33.3%
3
  50.0%
2
  33.3%
5
  10.0%
18
  27.3%
3
  14.3%
9
  27.3%
5
  26.3%
9
  36.0%
14
  23.7%
Drug-related TEAEs associated with dose reduction
0
   0.0%
0
   0.0%
0
   0.0%
2
  33.3%
3
  50.0%
2
  33.3%
4
   8.0%
18
  27.3%
2
   9.5%
9
  27.3%
4
  21.1%
9
  36.0%
13
  22.0%
TEAEs associated with dose interruption
1
  33.3%
1
  33.3%
0
   0.0%
6
 100.0%
4
  66.7%
3
  50.0%
21
  42.0%
36
  54.5%
8
  38.1%
13
  39.4%
9
  47.4%
13
  52.0%
22
  37.3%
Related TEAEs associated with dose interruption
1
  33.3%
0
   0.0%
0
   0.0%
3
  50.0%
3
  50.0%
2
  33.3%
15
  30.0%
28
  42.4%
7
  33.3%
11
  33.3%
5
  26.3%
11
  44.0%
17
  28.8%
Time Frame Treatment-emergent adverse event (TEAE) data were collected from baseline up to 28 days after the last dose of study drug, up to 3 years 5 months.
Adverse Event Reporting Description TEAEs were AEs that occur, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 28 days after the last dose. Serious adverse events with an onset or worsening ≥29 days after the last dose, if related to the study treatment, are also TEAEs. TEAEs from other HER2-expressing solid tumors other than breast or gastric were combined as prespecified in the protocol (excluding 1 patient with gastric cancer who received 5.4 mg/kg).
 
Arm/Group Title Dose Escalation: Cohort 1, 0.8 mg/kg Dose Escalation: Cohort 2, 1.6 mg/kg Dose Escalation: Cohort 3, 3.2 mg/kg Dose Escalation: Cohort 4, 5.4 mg/kg Dose Escalation: Cohort 5, 6.4 mg/kg Dose Escalation: Cohort 6, 8.0 mg/kg Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg Dose Expansion: HER2-expressing Other Solid Tumors
Hide Arm/Group Description Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1). Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1). Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1). Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1). Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1). Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1). Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1). Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
All-Cause Mortality
Dose Escalation: Cohort 1, 0.8 mg/kg Dose Escalation: Cohort 2, 1.6 mg/kg Dose Escalation: Cohort 3, 3.2 mg/kg Dose Escalation: Cohort 4, 5.4 mg/kg Dose Escalation: Cohort 5, 6.4 mg/kg Dose Escalation: Cohort 6, 8.0 mg/kg Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg Dose Expansion: HER2-expressing Other Solid Tumors
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   3/50 (6.00%)   1/66 (1.52%)   0/21 (0.00%)   0/33 (0.00%)   1/19 (5.26%)   1/25 (4.00%)   5/59 (8.47%) 
Hide Serious Adverse Events
Dose Escalation: Cohort 1, 0.8 mg/kg Dose Escalation: Cohort 2, 1.6 mg/kg Dose Escalation: Cohort 3, 3.2 mg/kg Dose Escalation: Cohort 4, 5.4 mg/kg Dose Escalation: Cohort 5, 6.4 mg/kg Dose Escalation: Cohort 6, 8.0 mg/kg Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg Dose Expansion: HER2-expressing Other Solid Tumors
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   1/6 (16.67%)   1/6 (16.67%)   1/6 (16.67%)   11/50 (22.00%)   17/66 (25.76%)   3/21 (14.29%)   12/33 (36.36%)   4/19 (21.05%)   7/25 (28.00%)   18/59 (30.51%) 
Blood and lymphatic system disorders                           
Anaemia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  2/66 (3.03%)  1/21 (4.76%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  3/59 (5.08%) 
Febrile neutropenia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  1/21 (4.76%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  3/59 (5.08%) 
Disseminated intravascular coagulation † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Gastrointestinal disorders                           
Vomiting † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Colitis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Constipation † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Diarrhoea haemorrhagic † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Dysphagia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Gastrointestinal haemorrhage † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Intestinal perforation † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Nausea † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Obstruction gastric † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Pancreatitis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Small intestine obstruction † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Stomatitis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Lower gastrointestinal haemorrhage † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Mechanical ileus † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Gastrointestinal mucosa hyperaemia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
General disorders                           
Disease progression † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  1/25 (4.00%)  1/59 (1.69%) 
Malaise † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Pain † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Pyrexia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Hepatobiliary disorders                           
Cholangitis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  2/25 (8.00%)  1/59 (1.69%) 
Hepatic function abnormal † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Immune system disorders                           
Contrast media allergy † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Infections and infestations                           
Pneumonia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/50 (4.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  2/19 (10.53%)  1/25 (4.00%)  0/59 (0.00%) 
Cellulitis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  1/21 (4.76%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Sepsis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  2/59 (3.39%) 
Lung infection † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  1/25 (4.00%)  0/59 (0.00%) 
Bacteraemia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  1/25 (4.00%)  0/59 (0.00%) 
Influenza † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Osteomyelitis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Peritonitis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Postoperative wound infection † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Pyelonephritis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Urinary tract infection † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Streptococcal bacteraemia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  1/21 (4.76%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Soft tissue infection † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Pneumocystis jirovecii pneumonia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Injury, poisoning and procedural complications                           
Humerus fracture † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Spinal compression fracture † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Radiation necrosis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Investigations                           
Platelet count decreased † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  4/66 (6.06%)  0/21 (0.00%)  2/33 (6.06%)  0/19 (0.00%)  1/25 (4.00%)  2/59 (3.39%) 
Aspartate aminotransferase increased † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Blood alkaline phosphatase increased † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Alanine aminotransferase increased † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Blood bilirubin increased † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Troponin increased † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Metabolism and nutrition disorders                           
Decreased appetite † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  2/66 (3.03%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  3/25 (12.00%)  2/59 (3.39%) 
Dehydration † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Hypercalcaemia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Hyperglycaemia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  1/19 (5.26%)  0/25 (0.00%)  0/59 (0.00%) 
Hypokalaemia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Hypomagnesaemia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Hypophosphataemia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Tumour lysis syndrome † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Musculoskeletal and connective tissue disorders                           
Muscular weakness † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Scleroderma-like reaction † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Nervous system disorders                           
Headache † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  1/19 (5.26%)  0/25 (0.00%)  0/59 (0.00%) 
Peroneal nerve palsy † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Seizure † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Transient ischaemic attack † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Renal and urinary disorders                           
Cystitis haemorrhagic † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Hydronephrosis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Respiratory, thoracic and mediastinal disorders                           
Pneumonitis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/50 (6.00%)  2/66 (3.03%)  0/21 (0.00%)  3/33 (9.09%)  0/19 (0.00%)  1/25 (4.00%)  1/59 (1.69%) 
Respiratory failure † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  4/50 (8.00%)  0/66 (0.00%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Interstitial lung disease † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  2/33 (6.06%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Pneumonia aspiration † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Pulmonary embolism † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  1/21 (4.76%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Pulmonary oedema † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Surgical and medical procedures                           
Central venous catheterisation † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Vascular disorders                           
Haematoma † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Hypotension † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dose Escalation: Cohort 1, 0.8 mg/kg Dose Escalation: Cohort 2, 1.6 mg/kg Dose Escalation: Cohort 3, 3.2 mg/kg Dose Escalation: Cohort 4, 5.4 mg/kg Dose Escalation: Cohort 5, 6.4 mg/kg Dose Escalation: Cohort 6, 8.0 mg/kg Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg Dose Expansion: HER2-expressing Other Solid Tumors
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   3/3 (100.00%)   3/3 (100.00%)   6/6 (100.00%)   6/6 (100.00%)   6/6 (100.00%)   50/50 (100.00%)   66/66 (100.00%)   20/21 (95.24%)   33/33 (100.00%)   19/19 (100.00%)   25/25 (100.00%)   59/59 (100.00%) 
Blood and lymphatic system disorders                           
Anaemia † 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  3/6 (50.00%)  2/6 (33.33%)  1/6 (16.67%)  23/50 (46.00%)  30/66 (45.45%)  7/21 (33.33%)  14/33 (42.42%)  4/19 (21.05%)  14/25 (56.00%)  23/59 (38.98%) 
Febrile neutropenia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  1/21 (4.76%)  3/33 (9.09%)  0/19 (0.00%)  1/25 (4.00%)  3/59 (5.08%) 
Cold type haemolytic anaemia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Cardiac disorders                           
Palpitations † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/50 (2.00%)  1/66 (1.52%)  2/21 (9.52%)  0/33 (0.00%)  2/19 (10.53%)  0/25 (0.00%)  0/59 (0.00%) 
Tachycardia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/50 (2.00%)  3/66 (4.55%)  1/21 (4.76%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Ear and labyrinth disorders                           
Tinnitus † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/50 (6.00%)  1/66 (1.52%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Vertigo † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  1/25 (4.00%)  1/59 (1.69%) 
Eye disorders                           
Dry eye † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  6/50 (12.00%)  8/66 (12.12%)  2/21 (9.52%)  1/33 (3.03%)  1/19 (5.26%)  0/25 (0.00%)  1/59 (1.69%) 
Keratitis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/50 (6.00%)  5/66 (7.58%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Cataract † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/50 (2.00%)  2/66 (3.03%)  1/21 (4.76%)  0/33 (0.00%)  0/19 (0.00%)  2/25 (8.00%)  2/59 (3.39%) 
Vision blurred † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  3/66 (4.55%)  0/21 (0.00%)  2/33 (6.06%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Conjunctival haemorrhage † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  2/50 (4.00%)  0/66 (0.00%)  1/21 (4.76%)  0/33 (0.00%)  1/19 (5.26%)  0/25 (0.00%)  0/59 (0.00%) 
Retinal degeneration † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  1/19 (5.26%)  0/25 (0.00%)  0/59 (0.00%) 
Retinal tear † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  1/19 (5.26%)  0/25 (0.00%)  0/59 (0.00%) 
Macular fibrosis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  1/19 (5.26%)  0/25 (0.00%)  0/59 (0.00%) 
Retinal haemorrhage † 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  1/66 (1.52%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  2/59 (3.39%) 
Corneal disorder † 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  2/50 (4.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Vitreous floaters † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  2/50 (4.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Uveitis † 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Gastrointestinal disorders                           
Nausea † 1  3/3 (100.00%)  1/3 (33.33%)  2/3 (66.67%)  6/6 (100.00%)  4/6 (66.67%)  4/6 (66.67%)  43/50 (86.00%)  52/66 (78.79%)  15/21 (71.43%)  26/33 (78.79%)  12/19 (63.16%)  19/25 (76.00%)  44/59 (74.58%) 
Vomiting † 1  1/3 (33.33%)  1/3 (33.33%)  2/3 (66.67%)  1/6 (16.67%)  4/6 (66.67%)  0/6 (0.00%)  28/50 (56.00%)  35/66 (53.03%)  10/21 (47.62%)  14/33 (42.42%)  3/19 (15.79%)  8/25 (32.00%)  31/59 (52.54%) 
Diarrhoea † 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  2/6 (33.33%)  1/6 (16.67%)  3/6 (50.00%)  18/50 (36.00%)  28/66 (42.42%)  9/21 (42.86%)  16/33 (48.48%)  3/19 (15.79%)  5/25 (20.00%)  19/59 (32.20%) 
Constipation † 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  4/6 (66.67%)  2/6 (33.33%)  1/6 (16.67%)  18/50 (36.00%)  30/66 (45.45%)  7/21 (33.33%)  14/33 (42.42%)  5/19 (26.32%)  7/25 (28.00%)  16/59 (27.12%) 
Stomatitis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  1/6 (16.67%)  1/6 (16.67%)  7/50 (14.00%)  18/66 (27.27%)  4/21 (19.05%)  13/33 (39.39%)  1/19 (5.26%)  4/25 (16.00%)  10/59 (16.95%) 
Abdominal pain † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  7/50 (14.00%)  9/66 (13.64%)  1/21 (4.76%)  2/33 (6.06%)  0/19 (0.00%)  0/25 (0.00%)  6/59 (10.17%) 
Dyspepsia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  2/6 (33.33%)  7/50 (14.00%)  9/66 (13.64%)  2/21 (9.52%)  1/33 (3.03%)  1/19 (5.26%)  0/25 (0.00%)  2/59 (3.39%) 
Abdominal distension † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  3/6 (50.00%)  0/6 (0.00%)  3/50 (6.00%)  8/66 (12.12%)  1/21 (4.76%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Abdominal pain upper † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/50 (4.00%)  5/66 (7.58%)  1/21 (4.76%)  2/33 (6.06%)  0/19 (0.00%)  0/25 (0.00%)  2/59 (3.39%) 
Flatulence † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  2/50 (4.00%)  3/66 (4.55%)  3/21 (14.29%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Gastrooesophageal reflux disease † 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  3/50 (6.00%)  1/66 (1.52%)  1/21 (4.76%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  2/59 (3.39%) 
Ascites † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/50 (4.00%)  2/66 (3.03%)  1/21 (4.76%)  0/33 (0.00%)  0/19 (0.00%)  1/25 (4.00%)  3/59 (5.08%) 
Dry mouth † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  2/50 (4.00%)  4/66 (6.06%)  1/21 (4.76%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Abdominal discomfort † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  4/50 (8.00%)  1/66 (1.52%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Gingival bleeding † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  3/50 (6.00%)  0/66 (0.00%)  1/21 (4.76%)  2/33 (6.06%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Haemorrhoids † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/50 (0.00%)  2/66 (3.03%)  0/21 (0.00%)  3/33 (9.09%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Gastritis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  1/66 (1.52%)  0/21 (0.00%)  2/33 (6.06%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Toothache † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  2/66 (3.03%)  0/21 (0.00%)  1/33 (3.03%)  1/19 (5.26%)  0/25 (0.00%)  1/59 (1.69%) 
Faeces discoloured † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  1/19 (5.26%)  0/25 (0.00%)  0/59 (0.00%) 
Periodontal disease † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  2/19 (10.53%)  0/25 (0.00%)  0/59 (0.00%) 
Eructation † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/50 (2.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Dental caries † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/50 (2.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Intestinal perforation † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
General disorders                           
Fatigue † 1  3/3 (100.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  3/6 (50.00%)  4/6 (66.67%)  24/50 (48.00%)  32/66 (48.48%)  11/21 (52.38%)  9/33 (27.27%)  4/19 (21.05%)  3/25 (12.00%)  21/59 (35.59%) 
Malaise † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  1/6 (16.67%)  6/50 (12.00%)  19/66 (28.79%)  2/21 (9.52%)  13/33 (39.39%)  3/19 (15.79%)  5/25 (20.00%)  13/59 (22.03%) 
Pyrexia † 1  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  10/50 (20.00%)  18/66 (27.27%)  1/21 (4.76%)  9/33 (27.27%)  3/19 (15.79%)  8/25 (32.00%)  9/59 (15.25%) 
Oedema peripheral † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  10/50 (20.00%)  10/66 (15.15%)  4/21 (19.05%)  4/33 (12.12%)  2/19 (10.53%)  1/25 (4.00%)  6/59 (10.17%) 
Oedema † 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  3/50 (6.00%)  7/66 (10.61%)  0/21 (0.00%)  1/33 (3.03%)  1/19 (5.26%)  4/25 (16.00%)  2/59 (3.39%) 
Chills † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  6/50 (12.00%)  5/66 (7.58%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Influenza-like illness † 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/50 (0.00%)  5/66 (7.58%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Pain † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/50 (6.00%)  2/66 (3.03%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Asthenia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  4/50 (8.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Chest discomfort † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  2/21 (9.52%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Hepatobiliary disorders                           
Hepatic function abnormal † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  1/33 (3.03%)  1/19 (5.26%)  3/25 (12.00%)  2/59 (3.39%) 
Cholangitis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  2/25 (8.00%)  1/59 (1.69%) 
Infections and infestations                           
Nasopharyngitis † 1  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  5/50 (10.00%)  9/66 (13.64%)  0/21 (0.00%)  4/33 (12.12%)  0/19 (0.00%)  3/25 (12.00%)  6/59 (10.17%) 
Upper respiratory tract infection † 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  9/50 (18.00%)  7/66 (10.61%)  1/21 (4.76%)  4/33 (12.12%)  0/19 (0.00%)  1/25 (4.00%)  4/59 (6.78%) 
Cystitis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  5/50 (10.00%)  6/66 (9.09%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  2/25 (8.00%)  2/59 (3.39%) 
Pneumonia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  4/50 (8.00%)  3/66 (4.55%)  0/21 (0.00%)  1/33 (3.03%)  2/19 (10.53%)  3/25 (12.00%)  1/59 (1.69%) 
Influenza † 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  1/6 (16.67%)  3/50 (6.00%)  3/66 (4.55%)  1/21 (4.76%)  0/33 (0.00%)  1/19 (5.26%)  1/25 (4.00%)  2/59 (3.39%) 
Lung infection † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  2/50 (4.00%)  3/66 (4.55%)  0/21 (0.00%)  1/33 (3.03%)  1/19 (5.26%)  2/25 (8.00%)  1/59 (1.69%) 
Urinary tract infection † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/50 (4.00%)  2/66 (3.03%)  0/21 (0.00%)  2/33 (6.06%)  0/19 (0.00%)  0/25 (0.00%)  3/59 (5.08%) 
Cellulitis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  3/66 (4.55%)  1/21 (4.76%)  3/33 (9.09%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Conjunctivitis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  3/50 (6.00%)  1/66 (1.52%)  0/21 (0.00%)  1/33 (3.03%)  1/19 (5.26%)  0/25 (0.00%)  1/59 (1.69%) 
Gastroenteritis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  3/50 (6.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Angular cheilitis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  2/25 (8.00%)  0/59 (0.00%) 
Bronchitis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/50 (4.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  1/19 (5.26%)  0/25 (0.00%)  0/59 (0.00%) 
Oral candidiasis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  1/19 (5.26%)  0/25 (0.00%)  1/59 (1.69%) 
Herpes zoster † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/50 (2.00%)  2/66 (3.03%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  1/25 (4.00%)  1/59 (1.69%) 
Paronychia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/50 (2.00%)  2/66 (3.03%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  2/59 (3.39%) 
Pharyngitis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/50 (0.00%)  2/66 (3.03%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  1/25 (4.00%)  1/59 (1.69%) 
Sinusitis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  1/21 (4.76%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Ear infection † 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Oral herpes † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/50 (0.00%)  0/66 (0.00%)  1/21 (4.76%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Folliculitis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  1/21 (4.76%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Soft tissue infection † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Mucosal infection † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Injury, poisoning and procedural complications                           
Fall † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  4/50 (8.00%)  3/66 (4.55%)  1/21 (4.76%)  2/33 (6.06%)  1/19 (5.26%)  0/25 (0.00%)  1/59 (1.69%) 
Infusion-related reaction † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  2/66 (3.03%)  1/21 (4.76%)  0/33 (0.00%)  1/19 (5.26%)  0/25 (0.00%)  0/59 (0.00%) 
Lumbar vertebral fracture † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  1/19 (5.26%)  0/25 (0.00%)  0/59 (0.00%) 
Thermal burn † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Investigations                           
Platelet count decreased † 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  4/6 (66.67%)  3/6 (50.00%)  3/6 (50.00%)  15/50 (30.00%)  24/66 (36.36%)  3/21 (14.29%)  14/33 (42.42%)  5/19 (26.32%)  12/25 (48.00%)  22/59 (37.29%) 
Neutrophil count decreased † 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  4/6 (66.67%)  2/6 (33.33%)  1/6 (16.67%)  12/50 (24.00%)  25/66 (37.88%)  3/21 (14.29%)  13/33 (39.39%)  2/19 (10.53%)  12/25 (48.00%)  21/59 (35.59%) 
White blood cell count decreased † 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  3/6 (50.00%)  2/6 (33.33%)  1/6 (16.67%)  9/50 (18.00%)  22/66 (33.33%)  4/21 (19.05%)  13/33 (39.39%)  3/19 (15.79%)  11/25 (44.00%)  17/59 (28.81%) 
Aspartate aminotransferase increased † 1  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  2/6 (33.33%)  1/6 (16.67%)  0/6 (0.00%)  9/50 (18.00%)  23/66 (34.85%)  3/21 (14.29%)  10/33 (30.30%)  1/19 (5.26%)  3/25 (12.00%)  12/59 (20.34%) 
Alanine aminotransferase increased † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  7/50 (14.00%)  17/66 (25.76%)  1/21 (4.76%)  7/33 (21.21%)  1/19 (5.26%)  3/25 (12.00%)  8/59 (13.56%) 
Weight decreased † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  5/50 (10.00%)  9/66 (13.64%)  3/21 (14.29%)  5/33 (15.15%)  2/19 (10.53%)  0/25 (0.00%)  11/59 (18.64%) 
Blood alkaline phosphatase increased † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  5/50 (10.00%)  7/66 (10.61%)  0/21 (0.00%)  4/33 (12.12%)  2/19 (10.53%)  1/25 (4.00%)  7/59 (11.86%) 
Electrocardiogram QT prolonged † 1  2/3 (66.67%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  5/50 (10.00%)  6/66 (9.09%)  4/21 (19.05%)  1/33 (3.03%)  1/19 (5.26%)  0/25 (0.00%)  1/59 (1.69%) 
Lymphocyte count decreased † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  1/6 (16.67%)  0/50 (0.00%)  8/66 (12.12%)  0/21 (0.00%)  2/33 (6.06%)  0/19 (0.00%)  4/25 (16.00%)  2/59 (3.39%) 
Blood creatinine increased † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  1/66 (1.52%)  1/21 (4.76%)  3/33 (9.09%)  1/19 (5.26%)  4/25 (16.00%)  4/59 (6.78%) 
Blood bilirubin increased † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  2/50 (4.00%)  7/66 (10.61%)  0/21 (0.00%)  2/33 (6.06%)  1/19 (5.26%)  1/25 (4.00%)  0/59 (0.00%) 
Weight increased † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  3/50 (6.00%)  6/66 (9.09%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Blood lactate dehydrogenase increased † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  3/50 (6.00%)  1/66 (1.52%)  1/21 (4.76%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Ejection fraction decreased † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  1/19 (5.26%)  1/25 (4.00%)  5/59 (8.47%) 
Protein total decreased † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/50 (4.00%)  1/66 (1.52%)  0/21 (0.00%)  2/33 (6.06%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Blood creatinine phosphokinase increased † 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Metabolism and nutrition disorders                           
Decreased appetite † 1  2/3 (66.67%)  1/3 (33.33%)  1/3 (33.33%)  4/6 (66.67%)  4/6 (66.67%)  2/6 (33.33%)  23/50 (46.00%)  47/66 (71.21%)  7/21 (33.33%)  20/33 (60.61%)  8/19 (42.11%)  22/25 (88.00%)  35/59 (59.32%) 
Hypokalaemia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  9/50 (18.00%)  13/66 (19.70%)  1/21 (4.76%)  6/33 (18.18%)  4/19 (21.05%)  3/25 (12.00%)  9/59 (15.25%) 
Hypoalbuminaemia † 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  5/50 (10.00%)  9/66 (13.64%)  2/21 (9.52%)  6/33 (18.18%)  0/19 (0.00%)  4/25 (16.00%)  5/59 (8.47%) 
Hyponatraemia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/50 (4.00%)  9/66 (13.64%)  1/21 (4.76%)  2/33 (6.06%)  0/19 (0.00%)  3/25 (12.00%)  5/59 (8.47%) 
Dehydration † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/50 (6.00%)  3/66 (4.55%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  7/59 (11.86%) 
Hypercalcaemia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/50 (4.00%)  0/66 (0.00%)  2/21 (9.52%)  2/33 (6.06%)  0/19 (0.00%)  1/25 (4.00%)  0/59 (0.00%) 
Hypomagnesaemia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/50 (4.00%)  1/66 (1.52%)  0/21 (0.00%)  2/33 (6.06%)  0/19 (0.00%)  0/25 (0.00%)  2/59 (3.39%) 
Hyperkalaemia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  1/21 (4.76%)  2/33 (6.06%)  0/19 (0.00%)  0/25 (0.00%)  2/59 (3.39%) 
Vitamin D deficiency † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  1/19 (5.26%)  0/25 (0.00%)  0/59 (0.00%) 
Musculoskeletal and connective tissue disorders                           
Back pain † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  5/50 (10.00%)  6/66 (9.09%)  2/21 (9.52%)  2/33 (6.06%)  0/19 (0.00%)  2/25 (8.00%)  4/59 (6.78%) 
Myalgia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  3/50 (6.00%)  6/66 (9.09%)  1/21 (4.76%)  2/33 (6.06%)  1/19 (5.26%)  0/25 (0.00%)  1/59 (1.69%) 
Arthralgia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/50 (6.00%)  4/66 (6.06%)  1/21 (4.76%)  4/33 (12.12%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Musculoskeletal pain † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/50 (4.00%)  2/66 (3.03%)  1/21 (4.76%)  1/33 (3.03%)  1/19 (5.26%)  0/25 (0.00%)  2/59 (3.39%) 
Muscular weakness † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/50 (4.00%)  2/66 (3.03%)  1/21 (4.76%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  3/59 (5.08%) 
Pain in extremity † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/50 (0.00%)  5/66 (7.58%)  1/21 (4.76%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Musculoskeletal chest pain † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/50 (6.00%)  2/66 (3.03%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Muscle spasms † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  2/50 (4.00%)  2/66 (3.03%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Joint stiffness † 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Osteoporosis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                           
Cancer pain † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  1/50 (2.00%)  2/66 (3.03%)  1/21 (4.76%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Tumour-associated fever † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Haemangioma of skin † 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Nervous system disorders                           
Dysgeusia † 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  4/50 (8.00%)  14/66 (21.21%)  3/21 (14.29%)  2/33 (6.06%)  2/19 (10.53%)  5/25 (20.00%)  9/59 (15.25%) 
Headache † 1  2/3 (66.67%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  8/50 (16.00%)  11/66 (16.67%)  0/21 (0.00%)  4/33 (12.12%)  4/19 (21.05%)  0/25 (0.00%)  4/59 (6.78%) 
Dizziness † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  8/50 (16.00%)  5/66 (7.58%)  3/21 (14.29%)  4/33 (12.12%)  0/19 (0.00%)  1/25 (4.00%)  8/59 (13.56%) 
Peripheral sensory neuropathy † 1  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/50 (2.00%)  6/66 (9.09%)  1/21 (4.76%)  3/33 (9.09%)  2/19 (10.53%)  0/25 (0.00%)  3/59 (5.08%) 
Neuropathy peripheral † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  4/50 (8.00%)  3/66 (4.55%)  2/21 (9.52%)  0/33 (0.00%)  1/19 (5.26%)  0/25 (0.00%)  1/59 (1.69%) 
Psychiatric disorders                           
Insomnia † 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  3/50 (6.00%)  6/66 (9.09%)  1/21 (4.76%)  3/33 (9.09%)  0/19 (0.00%)  2/25 (8.00%)  4/59 (6.78%) 
Anxiety † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/50 (6.00%)  2/66 (3.03%)  2/21 (9.52%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Depression † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/50 (0.00%)  2/66 (3.03%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Respiratory, thoracic and mediastinal disorders                           
Cough † 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  14/50 (28.00%)  12/66 (18.18%)  2/21 (9.52%)  5/33 (15.15%)  2/19 (10.53%)  1/25 (4.00%)  6/59 (10.17%) 
Epistaxis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  8/50 (16.00%)  6/66 (9.09%)  2/21 (9.52%)  2/33 (6.06%)  1/19 (5.26%)  3/25 (12.00%)  8/59 (13.56%) 
Pneumonitis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  3/50 (6.00%)  10/66 (15.15%)  1/21 (4.76%)  7/33 (21.21%)  0/19 (0.00%)  3/25 (12.00%)  5/59 (8.47%) 
Dyspnoea † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  7/50 (14.00%)  8/66 (12.12%)  3/21 (14.29%)  5/33 (15.15%)  1/19 (5.26%)  0/25 (0.00%)  4/59 (6.78%) 
Interstitial lung disease † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  6/66 (9.09%)  0/21 (0.00%)  3/33 (9.09%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Hiccups † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  2/25 (8.00%)  7/59 (11.86%) 
Nasal congestion † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  1/50 (2.00%)  3/66 (4.55%)  1/21 (4.76%)  3/33 (9.09%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Pleural effusion † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/50 (6.00%)  3/66 (4.55%)  0/21 (0.00%)  1/33 (3.03%)  2/19 (10.53%)  0/25 (0.00%)  0/59 (0.00%) 
Oropharyngeal pain † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  1/66 (1.52%)  0/21 (0.00%)  3/33 (9.09%)  0/19 (0.00%)  0/25 (0.00%)  3/59 (5.08%) 
Dysphonia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/50 (6.00%)  3/66 (4.55%)  1/21 (4.76%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Organising pneumonia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  3/50 (6.00%)  4/66 (6.06%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Dyspnoea exertional † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  4/66 (6.06%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Respiratory failure † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  4/50 (8.00%)  0/66 (0.00%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Upper-airway cough syndrome † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  1/66 (1.52%)  0/21 (0.00%)  2/33 (6.06%)  0/19 (0.00%)  0/25 (0.00%)  2/59 (3.39%) 
Rhinorrhoea † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  1/21 (4.76%)  0/33 (0.00%)  1/19 (5.26%)  0/25 (0.00%)  0/59 (0.00%) 
Hypoxia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  2/50 (4.00%)  3/66 (4.55%)  0/21 (0.00%)  2/33 (6.06%)  0/19 (0.00%)  0/25 (0.00%)  3/59 (5.08%) 
Rhinitis allergic † 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Productive cough † 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Skin and subcutaneous tissue disorders                           
Alopecia † 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  2/6 (33.33%)  3/6 (50.00%)  3/6 (50.00%)  19/50 (38.00%)  45/66 (68.18%)  6/21 (28.57%)  18/33 (54.55%)  4/19 (21.05%)  4/25 (16.00%)  20/59 (33.90%) 
Dry skin † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  5/50 (10.00%)  8/66 (12.12%)  1/21 (4.76%)  4/33 (12.12%)  1/19 (5.26%)  1/25 (4.00%)  6/59 (10.17%) 
Rash † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  6/50 (12.00%)  8/66 (12.12%)  0/21 (0.00%)  5/33 (15.15%)  1/19 (5.26%)  0/25 (0.00%)  2/59 (3.39%) 
Pruritus † 1  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  6/66 (9.09%)  1/21 (4.76%)  1/33 (3.03%)  0/19 (0.00%)  1/25 (4.00%)  3/59 (5.08%) 
Skin hyperpigmentation † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  4/50 (8.00%)  4/66 (6.06%)  0/21 (0.00%)  1/33 (3.03%)  2/19 (10.53%)  1/25 (4.00%)  2/59 (3.39%) 
Dermatitis acneiform † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  2/50 (4.00%)  1/66 (1.52%)  1/21 (4.76%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  4/59 (6.78%) 
Nail disorder † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/50 (0.00%)  4/66 (6.06%)  0/21 (0.00%)  2/33 (6.06%)  1/19 (5.26%)  0/25 (0.00%)  1/59 (1.69%) 
Rash maculo-papular † 1  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  3/50 (6.00%)  1/66 (1.52%)  0/21 (0.00%)  2/33 (6.06%)  0/19 (0.00%)  1/25 (4.00%)  0/59 (0.00%) 
Erythema † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  1/66 (1.52%)  0/21 (0.00%)  1/33 (3.03%)  1/19 (5.26%)  0/25 (0.00%)  0/59 (0.00%) 
Onychoclasis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/50 (2.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  1/19 (5.26%)  0/25 (0.00%)  0/59 (0.00%) 
Rash erythematous † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  1/19 (5.26%)  0/25 (0.00%)  0/59 (0.00%) 
Madarosis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  1/19 (5.26%)  0/25 (0.00%)  0/59 (0.00%) 
Urticaria † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  1/50 (2.00%)  2/66 (3.03%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  2/59 (3.39%) 
Nail discolouration † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/50 (2.00%)  2/66 (3.03%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Haemorrhage subcutaneous † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  2/50 (4.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/50 (2.00%)  1/66 (1.52%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Xeroderma † 1  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/50 (0.00%)  0/66 (0.00%)  0/21 (0.00%)  0/33 (0.00%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Vascular disorders                           
Hypertension † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  4/50 (8.00%)  2/66 (3.03%)  0/21 (0.00%)  4/33 (12.12%)  0/19 (0.00%)  1/25 (4.00%)  0/59 (0.00%) 
Hypotension † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/50 (4.00%)  5/66 (7.58%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  1/59 (1.69%) 
Hot flush † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/50 (4.00%)  2/66 (3.03%)  0/21 (0.00%)  2/33 (6.06%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
Lymphoedema † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  4/50 (8.00%)  0/66 (0.00%)  0/21 (0.00%)  1/33 (3.03%)  0/19 (0.00%)  0/25 (0.00%)  0/59 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Contact for Clinical Trial Information
Organization: Daiichi Sankyo, Inc.
Phone: 1-908-992-6400
EMail: CTRinfo@dsi.com
Publications of Results:
Tsurutani J, Iwata H, Krop I, Janne PA, Doi T, Takahashi S, Park H, Redfern C, Tamura K, Wise-Draper TM, Saito K, Sugihara M, Singh J, Jikoh T, Gallant G, Li BT. Targeting HER2 with Trastuzumab Deruxtecan: A Dose-Expansion, Phase I Study in Multiple Advanced Solid Tumors. Cancer Discov. 2020 May;10(5):688-701. doi: 10.1158/2159-8290.CD-19-1014. Epub 2020 Mar 25. Erratum In: Cancer Discov. 2020 Jul;10(7):1078.
Tamura K, Tsurutani J, Takahashi S, Iwata H, Krop IE, Redfern C, Sagara Y, Doi T, Park H, Murthy RK, Redman RA, Jikoh T, Lee C, Sugihara M, Shahidi J, Yver A, Modi S. Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive breast cancer previously treated with trastuzumab emtansine: a dose-expansion, phase 1 study. Lancet Oncol. 2019 Jun;20(6):816-826. doi: 10.1016/S1470-2045(19)30097-X. Epub 2019 Apr 29. Erratum In: Lancet Oncol. 2019 May 10;:
Shitara K, Iwata H, Takahashi S, Tamura K, Park H, Modi S, Tsurutani J, Kadowaki S, Yamaguchi K, Iwasa S, Saito K, Fujisaki Y, Sugihara M, Shahidi J, Doi T. Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive gastric cancer: a dose-expansion, phase 1 study. Lancet Oncol. 2019 Jun;20(6):827-836. doi: 10.1016/S1470-2045(19)30088-9. Epub 2019 Apr 29. Erratum In: Lancet Oncol. 2019 May 10;:
Modi S, Saura C, Yamashita T, Park YH, Kim SB, Tamura K, Andre F, Iwata H, Ito Y, Tsurutani J, Sohn J, Denduluri N, Perrin C, Aogi K, Tokunaga E, Im SA, Lee KS, Hurvitz SA, Cortes J, Lee C, Chen S, Zhang L, Shahidi J, Yver A, Krop I; DESTINY-Breast01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer. N Engl J Med. 2020 Feb 13;382(7):610-621. doi: 10.1056/NEJMoa1914510. Epub 2019 Dec 11.
Doi T, Shitara K, Naito Y, Shimomura A, Fujiwara Y, Yonemori K, Shimizu C, Shimoi T, Kuboki Y, Matsubara N, Kitano A, Jikoh T, Lee C, Fujisaki Y, Ogitani Y, Yver A, Tamura K. Safety, pharmacokinetics, and antitumour activity of trastuzumab deruxtecan (DS-8201), a HER2-targeting antibody-drug conjugate, in patients with advanced breast and gastric or gastro-oesophageal tumours: a phase 1 dose-escalation study. Lancet Oncol. 2017 Nov;18(11):1512-1522. doi: 10.1016/S1470-2045(17)30604-6. Epub 2017 Oct 13.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Daiichi Sankyo ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier: NCT02564900    
Other Study ID Numbers: DS8201-A-J101
152978 ( Registry Identifier: JAPIC CTI )
First Submitted: September 21, 2015
First Posted: October 1, 2015
Results First Submitted: July 14, 2020
Results First Posted: June 23, 2021
Last Update Posted: January 22, 2024