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Study of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-NHL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02669017
Recruitment Status : Completed
First Posted : January 29, 2016
Results First Posted : April 13, 2020
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
ADC Therapeutics S.A.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Non-Hodgkin Lymphoma
Burkitt's Lymphoma
Chronic Lymphocytic Leukemia
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Follicular
Lymphoma, Mantle-Cell
Lymphoma, Marginal Zone
Waldenstrom Macroglobulinemia
Primary Mediastinal B-cell Lymphoma
Intervention Drug: ADCT-402
Enrollment 183
Recruitment Details  
Pre-assignment Details Participants were screened at 11 sites in 3 countries.
Arm/Group Title Part 1: 15 μg/kg Q3W Part 1: 30 μg/kg Q3W Part 1: 60 μg/kg Q3W Part 1: 90 μg/kg Q3W Part 1: 120 μg/kg Q3W Part 2: 120 μg/kg Q3W Part 1: 150 μg/kg Q3W Part 2: 150 μg/kg Q3W Part 1: 200 μg/kg Q3W and Q6W
Hide Arm/Group Description Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
Period Title: Overall Study
Started 4 4 4 5 16 26 19 69 36
Completed 3 2 2 1 4 7 8 7 11
Not Completed 1 2 2 4 12 19 11 62 25
Reason Not Completed
Death             1             2             2             3             8             18             10             47             20
Withdrawal by Subject             0             0             0             1             2             0             0             2             2
Lost to Follow-up             0             0             0             0             0             0             0             0             1
Miscellaneous             0             0             0             0             2             1             1             13             2
Arm/Group Title Part 1: 15 μg/kg Q3W Part 1: 30 μg/kg Q3W Part 1: 60 μg/kg Q3W Part 1: 90 μg/kg Q3W Part 1: 120 μg/kg Q3W Part 2: 120 μg/kg Q3W Part 1: 150 μg/kg Q3W Part 2: 150 μg/kg Q3W Part 1: 200 μg/kg Q3W and Q6W Total
Hide Arm/Group Description Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W). Total of all reporting groups
Overall Number of Baseline Participants 4 4 4 5 16 26 19 69 36 183
Hide Baseline Analysis Population Description
All participants who received at least one dose of study treatment.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 5 participants 16 participants 26 participants 19 participants 69 participants 36 participants 183 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%
Between 18 and 65 years
1
  25.0%
1
  25.0%
3
  75.0%
2
  40.0%
3
  18.8%
14
  53.8%
13
  68.4%
43
  62.3%
19
  52.8%
99
  54.1%
>=65 years
3
  75.0%
3
  75.0%
1
  25.0%
3
  60.0%
13
  81.3%
12
  46.2%
6
  31.6%
26
  37.7%
17
  47.2%
84
  45.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 4 participants 5 participants 16 participants 26 participants 19 participants 69 participants 36 participants 183 participants
72.5  (8.39) 68.3  (11.53) 51.3  (18.82) 68.2  (12.38) 71.0  (10.20) 63.7  (13.37) 58.5  (13.96) 58.7  (15.82) 61.7  (12.82) 61.7  (14.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 5 participants 16 participants 26 participants 19 participants 69 participants 36 participants 183 participants
Female
2
  50.0%
2
  50.0%
2
  50.0%
3
  60.0%
3
  18.8%
7
  26.9%
6
  31.6%
34
  49.3%
10
  27.8%
69
  37.7%
Male
2
  50.0%
2
  50.0%
2
  50.0%
2
  40.0%
13
  81.3%
19
  73.1%
13
  68.4%
35
  50.7%
26
  72.2%
114
  62.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 5 participants 16 participants 26 participants 19 participants 69 participants 36 participants 183 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.8%
1
   5.3%
3
   4.3%
1
   2.8%
6
   3.3%
Not Hispanic or Latino
4
 100.0%
4
 100.0%
4
 100.0%
5
 100.0%
16
 100.0%
25
  96.2%
18
  94.7%
65
  94.2%
35
  97.2%
176
  96.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.4%
0
   0.0%
1
   0.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 4 participants 4 participants 4 participants 5 participants 16 participants 26 participants 19 participants 69 participants 36 participants 183 participants
White
4
 100.0%
4
 100.0%
4
 100.0%
4
  80.0%
14
  87.5%
19
  73.1%
19
 100.0%
61
  88.4%
35
  97.2%
164
  89.6%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
1
   6.3%
4
  15.4%
0
   0.0%
5
   7.2%
0
   0.0%
11
   6.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.3%
2
   7.7%
0
   0.0%
0
   0.0%
0
   0.0%
3
   1.6%
American Indian or Alaskan Native
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%
Native Hawaiian or Pacific Islander
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%
Other
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.8%
0
   0.0%
1
   1.4%
1
   2.8%
3
   1.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   2.9%
0
   0.0%
2
   1.1%
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 4 participants 4 participants 4 participants 5 participants 16 participants 26 participants 19 participants 68 participants 35 participants 181 participants
172.23  (18.438) 170.73  (12.545) 173.65  (11.544) 167.68  (10.275) 170.72  (8.977) 171.47  (9.790) 172.79  (10.584) 170.56  (11.908) 171.29  (12.193) 171.11  (11.221)
[1]
Measure Analysis Population Description: Height data was not collected for 2 participants because of complications during the collection of baseline measurements.
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 4 participants 4 participants 4 participants 5 participants 16 participants 26 participants 19 participants 69 participants 36 participants 183 participants
73.65  (7.204) 78.73  (25.445) 79.95  (26.942) 86.38  (23.597) 86.89  (25.996) 78.66  (18.113) 88.67  (20.820) 77.87  (22.453) 88.71  (24.834) 82.23  (22.635)
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 4 participants 4 participants 4 participants 5 participants 16 participants 26 participants 19 participants 68 participants 35 participants 181 participants
25.21  (3.971) 26.60  (5.466) 25.89  (5.428) 30.77  (8.931) 29.40  (6.882) 26.68  (5.458) 29.57  (5.575) 26.62  (6.648) 30.15  (7.235) 27.93  (6.587)
[1]
Measure Analysis Population Description: BMI could not be calculated for 2 participants due to missing height information.
Eastern Cooperative Oncology Group (ECOG) Performance Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 5 participants 16 participants 26 participants 19 participants 69 participants 36 participants 183 participants
0: Fully Active
2
  50.0%
0
   0.0%
2
  50.0%
0
   0.0%
7
  43.8%
7
  26.9%
4
  21.1%
20
  29.0%
12
  33.3%
54
  29.5%
1: Restricted in Physical Activity; Ambulatory
1
  25.0%
3
  75.0%
2
  50.0%
4
  80.0%
8
  50.0%
19
  73.1%
12
  63.2%
36
  52.2%
21
  58.3%
106
  57.9%
2: Ambulatory and Capable of All Self-care
1
  25.0%
1
  25.0%
0
   0.0%
1
  20.0%
1
   6.3%
0
   0.0%
2
  10.5%
12
  17.4%
3
   8.3%
21
  11.5%
3: Capable of Only Limited Self-care
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.3%
1
   1.4%
0
   0.0%
2
   1.1%
4: Completely Disabled
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%
5: Dead
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%
1.Primary Outcome
Title Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Hide Description

A DLT is defined as any of the following events, except those that are clearly due to underlying disease or extraneous causes:

A hematologic DLT is defined as:

  • CTCAE Grade 3 or 4 febrile neutropenia or neutropenic infection.
  • CTCAE Grade 4 neutropenia lasting >7 days.
  • CTCAE Grade 4 thrombocytopenia.
  • CTCAE Grade 3 thrombocytopenia with clinically significant bleeding, or Grade 3 thrombocytopenia requiring a platelet transfusion.
  • CTCAE Grade 4 anemia.

A non-hematologic DLT is defined as:

  • CTCAE Grade 4 tumor lysis syndrome (TLS). Grade 3 TLS will not constitute DLT unless it leads to irreversible end-organ damage.
  • CTCAE Grade 3 or higher AE (including nausea, vomiting, diarrhea, and electrolyte imbalances lasting more than 48 hours despite optimal therapy; excluding all grades of alopecia).
  • CTCAE Grade 3 or higher hypersensitivity reaction (regardless of premedication).
  • CTCAE Grade 2 or higher skin ulceration.
Time Frame Q3W schedule: Day 1 to End of Cycle 1 (3 weeks); Q6W schedule: Day 1 to End of Cycle 1 (6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in Part 1 who completed at least one cycle of treatment.
Arm/Group Title Part 1: 15 μg/kg Q3W Part 1: 30 μg/kg Q3W Part 1: 60 μg/kg Q3W Part 1: 90 μg/kg Q3W Part 1: 120 μg/kg Q3W Part 1: 150 μg/kg Q3W Part 1: 200 μg/kg Q3W and Q6W
Hide Arm/Group Description:
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
Overall Number of Participants Analyzed 4 4 3 5 16 16 25
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.3%
1
   6.3%
2
   8.0%
2.Primary Outcome
Title Recommended Dose of ADCT-402 for Part 2
Hide Description The recommended dose was established by the dose escalation steering committee and based on safety findings during Part 1 of the study.
Time Frame Q3W schedule: Day 1 to End of Cycle 1 (3 weeks); Q6W schedule: Day 1 to End of Cycle 1 (6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in Part 1 who completed at least one cycle of treatment.
Arm/Group Title Part 1: ADCT-402 Dose Escalation
Hide Arm/Group Description:

In Part 1 (dose escalation) participants received intravenous (IV) infusions of ADCT-402, at escalating doses according to a 3+3 study design. Doses assessed:

  • Dose Level 1: 15 μg/kg on Day 1 of each 3 week cycle (Q3W)
  • Dose Level 2: 30 μg/kg Day 1 Q3W
  • Dose Level 3: 60 μg/kg Day 1 Q3W
  • Dose Level 4: 90 μg/kg Day 1 Q3W
  • Dose Level 5: 120 μg/kg Day 1 Q3W
  • Dose Level 6: 150 μg/kg Day 1 Q3W
  • Dose Level 7: 200 μg/kg Day 1 Q3W and on Day 1 of each 6 week cycle (Q6W).
Overall Number of Participants Analyzed 73
Measure Type: Number
Unit of Measure: μg/kg
Recommended Part 2 Dose 1 120
Recommended Part 2 Dose 2 150
3.Primary Outcome
Title Number of Participants Reporting at Least One Treatment Emergent Adverse Event (TEAE)
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a participants enrolled into this study regardless of its causal relationship to study drug. A TEAE is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug.
Time Frame Day 1 to End of Study (a maximum of 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment.
Arm/Group Title Part 1: 15 μg/kg Q3W Part 1: 30 μg/kg Q3W Part 1: 60 μg/kg Q3W Part 1: 90 μg/kg Q3W Part 1: 120 μg/kg Q3W Part 2: 120 μg/kg Q3W Part 1: 150 μg/kg Q3W Part 2: 150 μg/kg Q3W Part 1: 200 μg/kg Q3W and Q6W
Hide Arm/Group Description:
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
Overall Number of Participants Analyzed 4 4 4 5 16 26 19 69 36
Measure Type: Count of Participants
Unit of Measure: Participants
4
 100.0%
3
  75.0%
4
 100.0%
5
 100.0%
16
 100.0%
26
 100.0%
19
 100.0%
68
  98.6%
36
 100.0%
4.Primary Outcome
Title Number of Participants Reporting at Least One Treatment Emergent Serious Adverse Event (SAE)
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a participant enrolled into this study regardless of its causal relationship to study drug. A treatment emergent AE (TEAE) is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug. An SAE is defined as any event that results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Time Frame Day 1 to End of Study (a maximum of 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment.
Arm/Group Title Part 1: 15 μg/kg Q3W Part 1: 30 μg/kg Q3W Part 1: 60 μg/kg Q3W Part 1: 90 μg/kg Q3W Part 1: 120 μg/kg Q3W Part 2: 120 μg/kg Q3W Part 1: 150 μg/kg Q3W Part 2: 150 μg/kg Q3W Part 1: 200 μg/kg Q3W and Q6W
Hide Arm/Group Description:
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
Overall Number of Participants Analyzed 4 4 4 5 16 26 19 69 36
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
1
  25.0%
0
   0.0%
4
  80.0%
4
  25.0%
14
  53.8%
6
  31.6%
40
  58.0%
15
  41.7%
5.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description

ORR was defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) at the time each participant discontinued treatment with ADCT-402, before the start of subsequent anticancer therapy or procedure. Tumor response was assessed using the 2014 Lugano Classification for response.

CR is defined as achieving either of the following:

  • Complete metabolic response.
  • Complete radiologic response (target node regress to <1.5 cm, no nonmeasured lesions, no organ enlargement, no new lesions and normal bone marrow morphology).

PR is defined as achieving either of the following:

  • Partial metabolic response (findings indicate residual disease).
  • Partial remission (>50% decrease in target measurable nodes, regression/ absence/ no increase of nonmeasured lesions, spleen regressed by >50% in length and no new lesions).
Time Frame Baseline to End of Study (a maximum of 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment with a valid baseline disease assessment and at least one valid post-baseline disease assessment.
Arm/Group Title Part 1: 15 μg/kg Q3W Part 1: 30 μg/kg Q3W Part 1: 60 μg/kg Q3W Part 1: 90 μg/kg Q3W Part 1: 120 μg/kg Q3W Part 2: 120 μg/kg Q3W Part 1: 150 μg/kg Q3W Part 2: 150 μg/kg Q3W Part 1: 200 μg/kg Q3W and Q6W
Hide Arm/Group Description:
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
Overall Number of Participants Analyzed 4 4 4 5 16 26 19 68 34
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
1
  25.0%
1
  25.0%
2
  40.0%
9
  56.3%
11
  42.3%
12
  63.2%
25
  36.8%
20
  58.8%
6.Secondary Outcome
Title Duration of Response (DoR)
Hide Description

DoR is defined among responders (complete response [CR] and partial response [PR]) as the time from the earliest date of first response until the first date of either disease progression or death due to any cause. Tumor response was assessed using the 2014 Lugano Classification for response.

Disease progression is defined as progressive metabolic disease or one of the follow:

  • Target node progression.
  • An individual extranodal lesion must be abnormal with length >1.5cm and/or increase of length >50%.
  • New or clear progression of nonmeasured lesions.
  • Regrowth of previously resolved lesions or new nodes >1.5 cm in length.
  • New or recurrent bone marrow involvement.

DoR is presented overall for all participants who received ADCT-402, as specified in protocol section 7.4.
Time Frame Baseline to End of Study (a maximum of 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment with a valid baseline disease assessment and at least one valid post-baseline disease assessment. Results are pooled for all arms as specified in the protocol.
Arm/Group Title Parts 1 and 2: ADCT-402
Hide Arm/Group Description:

In Part 1 (dose escalation) participants received intravenous (IV) infusions of ADCT-402, at escalating doses according to a 3+3 study design. Doses assessed:

  • Dose Level 1: 15 μg/kg on Day 1 of each 3 week cycle (Q3W)
  • Dose Level 2: 30 μg/kg Day 1 Q3W
  • Dose Level 3: 60 μg/kg Day 1 Q3W
  • Dose Level 4: 90 μg/kg Day 1 Q3W
  • Dose Level 5: 120 μg/kg Day 1 Q3W
  • Dose Level 6: 150 μg/kg Day 1 Q3W
  • Dose Level 7: 200 μg/kg Day 1 Q3W and on Day 1 of each 6 week cycle (Q6W).

In Part 2 (expansion), participants received intravenous (IV) infusions of ADCT-402 at either 120 μg/kg or 150 μg/kg on Day 1 of each 3 week cycle (Q3W).
Overall Number of Participants Analyzed 180
Median (95% Confidence Interval)
Unit of Measure: months
5.36 [1] 
(4.04 to NA)
[1]
Upper limit of the confidence interval was not reached.
7.Secondary Outcome
Title Overall Survival (OS)
Hide Description

OS is defined as the time from the first dose of study drug treatment until the date of death due to any cause.

OS is presented overall for all participants who received ADCT-402, as specified in protocol section 7.4.
Time Frame Baseline to End of Study (a maximum of 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment with a valid baseline disease assessment and at least one valid post-baseline disease assessment. Results are pooled for all arms as specified in the protocol.
Arm/Group Title Parts 1 and 2: ADCT-402
Hide Arm/Group Description:

In Part 1 (dose escalation) participants received intravenous (IV) infusions of ADCT-402, at escalating doses according to a 3+3 study design. Doses assessed:

  • Dose Level 1: 15 μg/kg on Day 1 of each 3 week cycle (Q3W)
  • Dose Level 2: 30 μg/kg Day 1 Q3W
  • Dose Level 3: 60 μg/kg Day 1 Q3W
  • Dose Level 4: 90 μg/kg Day 1 Q3W
  • Dose Level 5: 120 μg/kg Day 1 Q3W
  • Dose Level 6: 150 μg/kg Day 1 Q3W
  • Dose Level 7: 200 μg/kg Day 1 Q3W and on Day 1 of each 6 week cycle (Q6W).

In Part 2 (expansion), participants received intravenous (IV) infusions of ADCT-402 at either 120 μg/kg or 150 μg/kg on Day 1 of each 3 week cycle (Q3W).
Overall Number of Participants Analyzed 180
Median (95% Confidence Interval)
Unit of Measure: months
8.25
(6.74 to 10.68)
8.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description

PFS is defined among the efficacy population as the time from first dose of study drug until either disease progression or death due to any cause. Tumor response was assessed using the 2014 Lugano Classification for response.

Disease progression is defined as progressive metabolic disease or one of the follow:

  • Target node progression.
  • An individual extranodal lesion must be abnormal with length >1.5cm and/or increase of length >50%.
  • New or clear progression of nonmeasured lesions.
  • Regrowth of previously resolved lesions or new nodes >1.5 cm in length.
  • New or recurrent bone marrow involvement.

PFS is presented overall for all participants who received ADCT-402, as specified in protocol section 7.4.
Time Frame Baseline to End of Study (a maximum of 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study treatment with a valid baseline disease assessment and at least one valid post-baseline disease assessment. Results are pooled for all arms as specified in the protocol.
Arm/Group Title Parts 1 and 2: ADCT-402
Hide Arm/Group Description:

In Part 1 (dose escalation) participants received intravenous (IV) infusions of ADCT-402, at escalating doses according to a 3+3 study design. Doses assessed:

  • Dose Level 1: 15 μg/kg on Day 1 of each 3 week cycle (Q3W)
  • Dose Level 2: 30 μg/kg Day 1 Q3W
  • Dose Level 3: 60 μg/kg Day 1 Q3W
  • Dose Level 4: 90 μg/kg Day 1 Q3W
  • Dose Level 5: 120 μg/kg Day 1 Q3W
  • Dose Level 6: 150 μg/kg Day 1 Q3W
  • Dose Level 7: 200 μg/kg Day 1 Q3W and on Day 1 of each 6 week cycle (Q6W).

In Part 2 (expansion), participants received intravenous (IV) infusions of ADCT-402 at either 120 μg/kg or 150 μg/kg on Day 1 of each 3 week cycle (Q3W).
Overall Number of Participants Analyzed 180
Median (95% Confidence Interval)
Unit of Measure: months
3.09
(2.66 to 4.24)
9.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) for ADCT-402
Hide Description

Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).

Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Time Frame Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Arm/Group Title Part 1: 15 μg/kg Q3W Part 1: 30 μg/kg Q3W Part 1: 60 μg/kg Q3W Part 1: 90 μg/kg Q3W Parts 1 and 2: 120 μg/kg Q3W Parts 1 and 2: 150 μg/kg Q3W Part 1: 200 μg/kg Q3W Part 1: 200 μg/kg Q6W
Hide Arm/Group Description:
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Overall Number of Participants Analyzed 4 4 4 5 42 88 14 22
Mean (Standard Deviation)
Unit of Measure: ng/mL
PBD conjugated Ab: Cycle 1 Number Analyzed 4 participants 4 participants 4 participants 5 participants 42 participants 88 participants 14 participants 22 participants
260  (85.5) 404  (161) 721  (481) 1088  (748) 2374  (1040) 3416  (3093) 3619  (688) 3798  (1332)
PBD conjugated Ab: Cycle 2 Number Analyzed 4 participants 4 participants 3 participants 5 participants 40 participants 72 participants 11 participants 12 participants
398  (284) 1971  (2566) 864  (686) 1416  (799) 2573  (655) 3776  (2738) 4293  (1021) 3178  (1733)
total Ab: Cycle 1 Number Analyzed 4 participants 4 participants 4 participants 5 participants 41 participants 88 participants 14 participants 22 participants
298  (83.7) 542  (192) 856  (475) 1560  (1102) 2829  (1257) 4383  (4460) 4185  (1308) 4543  (1805)
total Ab: Cycle 2 Number Analyzed 4 participants 4 participants 3 participants 5 participants 39 participants 72 participants 11 participants 12 participants
447  (283) 2906  (4034) 1275  (1025) 2422  (983) 3142  (888) 4798  (3334) 5059  (1027) 3834  (1913)
SG3199: Cycle 1 Number Analyzed 0 participants 0 participants 0 participants 1 participants 4 participants 28 participants 4 participants 16 participants
0.102 [1]   (NA) 0.0372  (0.0208) 0.0570  (0.0454) 0.0479  (0.0381) 0.0468  (0.0333)
SG3199: Cycle 2 Number Analyzed 0 participants 0 participants 0 participants 2 participants 4 participants 15 participants 3 participants 4 participants
0.0704  (0.0152) 0.0403  (0.0116) 0.0485  (0.0449) 0.0293  (0.00329) 0.0516  (0.0325)
[1]
Standard deviation could not be determined as only one participant had evaluable data.
10.Secondary Outcome
Title Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402
Hide Description

Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).

Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Time Frame Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Arm/Group Title Part 1: 15 μg/kg Q3W Part 1: 30 μg/kg Q3W Part 1: 60 μg/kg Q3W Part 1: 90 μg/kg Q3W Parts 1 and 2: 120 μg/kg Q3W Parts 1 and 2: 150 μg/kg Q3W Part 1: 200 μg/kg Q3W Part 1: 200 μg/kg Q6W
Hide Arm/Group Description:
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Overall Number of Participants Analyzed 4 4 4 5 42 88 14 22
Median (Full Range)
Unit of Measure: days
PBD conjugated Ab: Cycle 1 Number Analyzed 4 participants 4 participants 4 participants 5 participants 42 participants 88 participants 14 participants 22 participants
0.0837
(0.0833 to 0.0854)
0.0833
(0.0431 to 0.319)
0.0819
(0.0417 to 0.0847)
0.0500
(0.0417 to 0.0875)
0.0833
(0.0403 to 0.296)
0.0840
(0.0417 to 0.305)
0.0858
(0.0417 to 0.285)
0.0840
(0.0417 to 0.276)
PBD conjugated Ab: Cycle 2 Number Analyzed 4 participants 4 participants 3 participants 5 participants 40 participants 72 participants 11 participants 12 participants
0.122
(0.0660 to 0.170)
0.0618
(0.0417 to 0.0875)
0.0417
(0.0222 to 0.165)
0.0833
(0.0229 to 0.0882)
0.0830
(0.0208 to 0.278)
0.0642
(0.0208 to 1.00)
0.0854
(0.0208 to 1.00)
0.0826
(0.0257 to 0.172)
total Ab: Cycle 1 Number Analyzed 4 participants 4 participants 4 participants 5 participants 41 participants 88 participants 14 participants 22 participants
0.0844
(0.0438 to 0.292)
0.0833
(0.0431 to 0.0896)
0.0833
(0.0806 to 0.0847)
0.0500
(0.0417 to 0.169)
0.0833
(0.0403 to 0.294)
0.0837
(0.0403 to 0.299)
0.0840
(0.0417 to 0.285)
0.0837
(0.0417 to 0.271)
total Ab: Cycle 2 Number Analyzed 4 participants 4 participants 3 participants 5 participants 39 participants 72 participants 11 participants 12 participants
0.0649
(0.0431 to 0.0868)
0.0618
(0.0417 to 0.0875)
0.0417
(0.0222 to 0.0854)
0.0833
(0.0229 to 0.159)
0.0632
(0.0208 to 0.275)
0.0639
(0 to 2.11)
0.132
(0.0208 to 4.00)
0.0858
(0.0257 to 0.172)
SG3199: Cycle 1 Number Analyzed 0 participants 0 participants 0 participants 1 participants 4 participants 28 participants 4 participants 16 participants
0.0833
(0.0833 to 0.0833)
0.0854
(0.0458 to 0.172)
0.0844
(0.0417 to 0.294)
0.128
(0.0833 to 0.285)
0.165
(0.0417 to 6.81)
SG3199: Cycle 2 Number Analyzed 0 participants 0 participants 0 participants 2 participants 4 participants 15 participants 3 participants 4 participants
1.05
(0.0417 to 2.06)
0.120
(0.0840 to 0.153)
0.0632
(0.0222 to 13.8)
0.165
(0.0299 to 0.992)
0.162
(0.0833 to 0.280)
11.Secondary Outcome
Title Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402
Hide Description

AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).

Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Time Frame Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Arm/Group Title Part 1: 15 μg/kg Q3W Part 1: 30 μg/kg Q3W Part 1: 60 μg/kg Q3W Part 1: 90 μg/kg Q3W Parts 1 and 2: 120 μg/kg Q3W Parts 1 and 2: 150 μg/kg Q3W Part 1: 200 μg/kg Q3W Part 1: 200 μg/kg Q6W
Hide Arm/Group Description:
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Overall Number of Participants Analyzed 4 4 4 5 42 88 14 22
Mean (Standard Deviation)
Unit of Measure: day*ng/mL
PBD conjugated Ab: Cycle 1 Number Analyzed 4 participants 4 participants 4 participants 5 participants 42 participants 88 participants 14 participants 22 participants
1063  (1340) 2390  (826) 3875  (3228) 6587  (6842) 13544  (7503) 14258  (8248) 30571  (12425) 30386  (16960)
PBD conjugated Ab: Cycle 2 Number Analyzed 4 participants 4 participants 3 participants 5 participants 40 participants 72 participants 11 participants 12 participants
1933  (2289) 2955  (1132) 5573  (4827) 10369  (11656) 18707  (10505) 23109  (15370) 48183  (20288) 39609  (24852)
total Ab: Cycle 1 Number Analyzed 4 participants 4 participants 4 participants 5 participants 41 participants 88 participants 14 participants 22 participants
1185  (1540) 3194  (1136) 5032  (4334) 8869  (9108) 15980  (7649) 16973  (9745) 33834  (14888) 36099  (20829)
total Ab: Cycle 2 Number Analyzed 4 participants 4 participants 3 participants 5 participants 39 participants 72 participants 11 participants 12 participants
1924  (2576) 3986  (1725) 7958  (6882) 14025  (15704) 23428  (13513) 28657  (19457) 57450  (26899) 49892  (31012)
SG3199: Cycle 1 Number Analyzed 0 participants 0 participants 0 participants 1 participants 4 participants 28 participants 4 participants 16 participants
0.00213 [1]   (NA) 0.00462  (0.00671) 0.0222  (0.0423) 0.0174  (0.0303) 0.0436  (0.0959)
SG3199: Cycle 2 Number Analyzed 0 participants 0 participants 0 participants 2 participants 4 participants 15 participants 3 participants 4 participants
0.0242  (0.0234) 0.154  (0.286) 0.0108  (0.0248) 0.00425  (0.00461) 0.00332  (0.00215)
[1]
Standard deviation could not be determined as only one participant had evaluable data.
12.Secondary Outcome
Title Area Under the Serum Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) for ADCT-402
Hide Description

AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).

Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Time Frame Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Arm/Group Title Part 1: 15 μg/kg Q3W Part 1: 30 μg/kg Q3W Part 1: 60 μg/kg Q3W Part 1: 90 μg/kg Q3W Parts 1 and 2: 120 μg/kg Q3W Parts 1 and 2: 150 μg/kg Q3W Part 1: 200 μg/kg Q3W Part 1: 200 μg/kg Q6W
Hide Arm/Group Description:
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Overall Number of Participants Analyzed 4 4 3 5 40 72 11 12
Mean (Standard Deviation)
Unit of Measure: day*ng/mL
PBD conjugated Ab: Cycle 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
PBD conjugated Ab: Cycle 2 Number Analyzed 4 participants 4 participants 2 participants 5 participants 40 participants 72 participants 11 participants 12 participants
2285  (2928) 3458  (1426) 10575  (1121) 10171  (11244) 19890  (8968) 22859  (12080) 39362  (9800) 38466  (23514)
total Ab: Cycle 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
total Ab: Cycle 2 Number Analyzed 4 participants 4 participants 3 participants 4 participants 39 participants 72 participants 11 participants 12 participants
2636  (3387) 4662  (2096) 10211  (8827) 17141  (15029) 24247  (10902) 28041  (15312) 46469  (12675) 48524  (28858)
SG3199: Cycle 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
SG3199: Cycle 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
13.Secondary Outcome
Title Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for ADCT-402
Hide Description

AUCinf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).

Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Time Frame Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
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Hide Analysis Population Description
Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Arm/Group Title Part 1: 15 μg/kg Q3W Part 1: 30 μg/kg Q3W Part 1: 60 μg/kg Q3W Part 1: 90 μg/kg Q3W Parts 1 and 2: 120 μg/kg Q3W Parts 1 and 2: 150 μg/kg Q3W Part 1: 200 μg/kg Q3W Part 1: 200 μg/kg Q6W
Hide Arm/Group Description:
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Overall Number of Participants Analyzed 3 2 2 2 15 47 4 13
Mean (Standard Deviation)
Unit of Measure: day*ng/mL
PBD conjugated Ab: Cycle 1 Number Analyzed 3 participants 2 participants 2 participants 2 participants 15 participants 47 participants 4 participants 13 participants
432  (173) 2001  (663) 5333  (4002) 5622  (7170) 10232  (6220) 11498  (8175) 29174  (25838) 32629  (19488)
PBD conjugated Ab: Cycle 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
total Ab: Cycle 1 Number Analyzed 1 participants 0 participants 0 participants 1 participants 12 participants 37 participants 2 participants 12 participants
869 [1]   (NA) 16409 [1]   (NA) 13292  (8495) 12692  (8968) 38991  (53597) 43952  (24032)
total Ab: Cycle 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
SG3199: Cycle 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
0.154 [1]   (NA)
SG3199: Cycle 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
[1]
Standard deviation could not be determined as only one participant had evaluable data.
14.Secondary Outcome
Title Terminal Half-life (Thalf) of ADCT-402
Hide Description

Thalf of Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).

Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Time Frame Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
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Hide Analysis Population Description
Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Arm/Group Title Part 1: 15 μg/kg Q3W Part 1: 30 μg/kg Q3W Part 1: 60 μg/kg Q3W Part 1: 90 μg/kg Q3W Parts 1 and 2: 120 μg/kg Q3W Parts 1 and 2: 150 μg/kg Q3W Part 1: 200 μg/kg Q3W Part 1: 200 μg/kg Q6W
Hide Arm/Group Description:
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Overall Number of Participants Analyzed 4 4 2 4 38 69 11 13
Median (Full Range)
Unit of Measure: days
PBD conjugated Ab: Cycle 1 Number Analyzed 3 participants 2 participants 2 participants 2 participants 15 participants 47 participants 4 participants 13 participants
1.15
(1.04 to 2.56)
6.84
(5.74 to 7.94)
6.30
(4.30 to 8.30)
3.97
(0.923 to 7.01)
6.33
(0.515 to 9.50)
6.43
(0.146 to 13.1)
7.96
(6.43 to 16.6)
10.4
(0.0560 to 19.6)
PBD conjugated Ab: Cycle 2 Number Analyzed 4 participants 4 participants 2 participants 4 participants 38 participants 69 participants 11 participants 12 participants
3.98
(0.909 to 11.1)
10.1
(6.72 to 17.1)
16.3
(11.1 to 21.4)
11.4
(1.78 to 19.2)
12.5
(1.74 to 28.7)
11.6
(1.50 to 33.0)
16.3
(8.14 to 28.8)
15.5
(4.82 to 25.0)
total Ab: Cycle 1 Number Analyzed 1 participants 0 participants 0 participants 1 participants 12 participants 37 participants 2 participants 12 participants
2.75
(2.75 to 2.75)
8.82
(8.82 to 8.82)
7.00
(0.325 to 10.6)
6.58
(0.0759 to 17.7)
9.39
(0.661 to 18.1)
12.7
(0.248 to 19.0)
total Ab: Cycle 2 Number Analyzed 4 participants 3 participants 2 participants 4 participants 34 participants 66 participants 10 participants 12 participants
3.71
(0.860 to 13.0)
9.58
(7.11 to 15.4)
16.5
(12.9 to 20.0)
13.4
(1.27 to 38.5)
14.9
(2.07 to 33.5)
14.3
(0.269 to 36.0)
14.7
(8.47 to 27.8)
18.4
(6.18 to 39.9)
SG3199: Cycle 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
SG3199: Cycle 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
15.Secondary Outcome
Title Apparent Clearance (CL) at Steady State for ADCT-402
Hide Description

CL of Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).

Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Time Frame Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Arm/Group Title Part 1: 15 μg/kg Q3W Part 1: 30 μg/kg Q3W Part 1: 60 μg/kg Q3W Part 1: 90 μg/kg Q3W Parts 1 and 2: 120 μg/kg Q3W Parts 1 and 2: 150 μg/kg Q3W Part 1: 200 μg/kg Q3W Part 1: 200 μg/kg Q6W
Hide Arm/Group Description:
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Overall Number of Participants Analyzed 4 4 3 5 40 72 11 13
Mean (Standard Deviation)
Unit of Measure: liters/day
PBD conjugated Ab: Cycle 1 Number Analyzed 3 participants 2 participants 2 participants 2 participants 15 participants 47 participants 4 participants 13 participants
2.49  (0.978) 1.08  (0.164) 0.696  (0.444) 7.13  (8.91) 2.09  (4.07) 3.84  (8.53) 3.11  (5.30) 12.6  (39.4)
PBD conjugated Ab: Cycle 2 Number Analyzed 4 participants 4 participants 2 participants 5 participants 40 participants 72 participants 11 participants 12 participants
1.78  (1.80) 0.646  (0.348) 0.415  (0.205) 19.6  (40.6) 17.8  (109) 0.986  (2.48) 0.407  (0.143) 0.349  (0.210)
total Ab: Cycle 1 Number Analyzed 1 participants 0 participants 0 participants 1 participants 12 participants 37 participants 2 participants 12 participants
1.28 [1]   (NA) 0.640 [1]   (NA) 2.47  (5.00) 3.87  (8.95) 7.12  (9.62) 2.02  (5.11)
total Ab: Cycle 2 Number Analyzed 4 participants 4 participants 3 participants 4 participants 39 participants 72 participants 11 participants 12 participants
1.76  (1.71) 0.577  (0.309) 38.1  (65.5) 1.42  (2.06) 0.581  (0.660) 1.05  (2.91) 0.417  (0.161) 0.323  (0.187)
SG3199: Cycle 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
627 [1]   (NA)
SG3199: Cycle 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
[1]
Standard deviation could not be determined as only one participant had evaluable data.
16.Secondary Outcome
Title Volume of Distribution at Steady State (Vss) for ADCT-402
Hide Description

Vss for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).

Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Time Frame Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Arm/Group Title Part 1: 15 μg/kg Q3W Part 1: 30 μg/kg Q3W Part 1: 60 μg/kg Q3W Part 1: 90 μg/kg Q3W Parts 1 and 2: 120 μg/kg Q3W Parts 1 and 2: 150 μg/kg Q3W Part 1: 200 μg/kg Q3W Part 1: 200 μg/kg Q6W
Hide Arm/Group Description:
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Overall Number of Participants Analyzed 4 4 2 4 38 69 11 13
Mean (Standard Deviation)
Unit of Measure: liters
PBD conjugated Ab: Cycle 1 Number Analyzed 3 participants 2 participants 2 participants 2 participants 15 participants 47 participants 4 participants 13 participants
4.47  (0.759) 10.3  (4.83) 4.96  (0.318) 9.68  (2.68) 5.95  (1.86) 7.59  (6.18) 11.5  (11.1) 7.18  (2.52)
PBD conjugated Ab: Cycle 2 Number Analyzed 4 participants 4 participants 2 participants 4 participants 38 participants 69 participants 11 participants 12 participants
3.82  (1.25) 10.1  (8.57) 8.29  (0.540) 7.62  (1.09) 6.71  (3.13) 7.48  (4.29) 9.18  (3.43) 6.21  (1.70)
total Ab: Cycle 1 Number Analyzed 1 participants 0 participants 0 participants 1 participants 12 participants 37 participants 2 participants 12 participants
4.71 [1]   (NA) 7.84 [1]   (NA) 5.51  (1.29) 6.60  (3.16) 7.91  (0.0252) 7.20  (2.03)
total Ab: Cycle 2 Number Analyzed 4 participants 3 participants 2 participants 4 participants 34 participants 66 participants 10 participants 12 participants
3.83  (0.854) 9.62  (8.54) 7.30  (1.38) 8.52  (1.34) 8.11  (4.57) 8.21  (3.64) 9.46  (5.26) 6.86  (2.27)
SG3199: Cycle 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
335 [1]   (NA)
SG3199: Cycle 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
[1]
Standard deviation could not be determined as only one participant had evaluable data.
17.Secondary Outcome
Title Accumulation Index (AI) for ADCT-402
Hide Description

AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199). AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1 (Q3W schedule: 3 week cycle length; Q6W schedule: 6 week cycle length). It is the increase in drug plasma concentration after multiple dosing until a steady state is reached.

Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Time Frame Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Arm/Group Title Part 1: 15 μg/kg Q3W Part 1: 30 μg/kg Q3W Part 1: 60 μg/kg Q3W Part 1: 90 μg/kg Q3W Parts 1 and 2: 120 μg/kg Q3W Parts 1 and 2: 150 μg/kg Q3W Part 1: 200 μg/kg Q3W Part 1: 200 μg/kg Q6W
Hide Arm/Group Description:
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Overall Number of Participants Analyzed 4 4 2 4 38 69 11 12
Mean (Standard Deviation)
Unit of Measure: ratio
PBD conjugated Ab: Cycle 2 Number Analyzed 4 participants 4 participants 2 participants 4 participants 38 participants 69 participants 11 participants 12 participants
1.12  (0.173) 1.37  (0.264) 1.70  (0.467) 1.42  (0.399) 1.47  (0.369) 1.46  (0.368) 1.76  (0.385) 1.23  (0.160)
total Ab: Cycle 2 Number Analyzed 4 participants 3 participants 2 participants 4 participants 34 participants 66 participants 10 participants 12 participants
1.15  (0.229) 1.35  (0.252) 1.71  (0.325) 1.80  (0.962) 1.62  (0.492) 1.63  (0.486) 1.78  (0.418) 1.36  (0.314)
SG3199: Cycle 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
18.Secondary Outcome
Title Number of Participants With Anti-drug Antibody Response (ADA) Against ADCT-402
Hide Description

Blood serum samples were collected and analysed to determine the presence or absence of ADA.

ADA is presented overall for all participants who received ADCT-402, as specified in protocol section 7.4.
Time Frame Q3W schedule: Day 1 to End of Cycle 1 (3 weeks); Q6W schedule: Day 1 to End of Cycle 1 (6 weeks)
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Hide Analysis Population Description
All participants who were tested for ADA.
Arm/Group Title Parts 1 and 2: ADCT-402
Hide Arm/Group Description:

In Part 1 (dose escalation) participants received intravenous (IV) infusions of ADCT-402, at escalating doses according to a 3+3 study design. Doses assessed:

  • Dose Level 1: 15 μg/kg on Day 1 of each 3 week cycle (Q3W)
  • Dose Level 2: 30 μg/kg Day 1 Q3W
  • Dose Level 3: 60 μg/kg Day 1 Q3W
  • Dose Level 4: 90 μg/kg Day 1 Q3W
  • Dose Level 5: 120 μg/kg Day 1 Q3W
  • Dose Level 6: 150 μg/kg Day 1 Q3W
  • Dose Level 7: 200 μg/kg Day 1 Q3W and on Day 1 of each 6 week cycle (Q6W).

In Part 2 (expansion), participants received intravenous (IV) infusions of ADCT-402 at either 120 μg/kg or 150 μg/kg on Day 1 of each 3 week cycle (Q3W).
Overall Number of Participants Analyzed 183
Measure Type: Count of Participants
Unit of Measure: Participants
Confirmed positive ADA pre-dose
5
   2.7%
Confirmed positive ADA post-dose only
1
   0.5%
Confirmed positive ADA at anytime
6
   3.3%
Time Frame Day 1 to End of Study (a maximum of 18 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part 1: 15 μg/kg Q3W Part 1: 30 μg/kg Q3W Part 1: 60 μg/kg Q3W Part 1: 90 μg/kg Q3W Part 1: 120 μg/kg Q3W Part 2: 120 μg/kg Q3W Part 1: 150 μg/kg Q3W Part 2: 150 μg/kg Q3W Part 1: 200 μg/kg Q3W and Q6W
Hide Arm/Group Description Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
All-Cause Mortality
Part 1: 15 μg/kg Q3W Part 1: 30 μg/kg Q3W Part 1: 60 μg/kg Q3W Part 1: 90 μg/kg Q3W Part 1: 120 μg/kg Q3W Part 2: 120 μg/kg Q3W Part 1: 150 μg/kg Q3W Part 2: 150 μg/kg Q3W Part 1: 200 μg/kg Q3W and Q6W
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   1/4 (25.00%)   2/4 (50.00%)   2/4 (50.00%)   3/5 (60.00%)   8/16 (50.00%)   18/26 (69.23%)   10/19 (52.63%)   47/69 (68.12%)   20/36 (55.56%) 
Hide Serious Adverse Events
Part 1: 15 μg/kg Q3W Part 1: 30 μg/kg Q3W Part 1: 60 μg/kg Q3W Part 1: 90 μg/kg Q3W Part 1: 120 μg/kg Q3W Part 2: 120 μg/kg Q3W Part 1: 150 μg/kg Q3W Part 2: 150 μg/kg Q3W Part 1: 200 μg/kg Q3W and Q6W
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   1/4 (25.00%)   1/4 (25.00%)   0/4 (0.00%)   4/5 (80.00%)   4/16 (25.00%)   4/26 (15.38%)   6/19 (31.58%)   40/69 (57.97%)   15/36 (41.67%) 
Blood and lymphatic system disorders                   
Febrile neutropenia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  1/16 (6.25%)  1/26 (3.85%)  1/19 (5.26%)  5/69 (7.25%)  1/36 (2.78%) 
Anaemia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Neutropenia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Cardiac disorders                   
Pericardial effusion * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  1/69 (1.45%)  1/36 (2.78%) 
Cardiac arrest * 1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Supraventricular tachycardia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  1/36 (2.78%) 
Endocrine disorders                   
Hypothyroidism * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Gastrointestinal disorders                   
Abdominal pain * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  2/26 (7.69%)  0/19 (0.00%)  1/69 (1.45%)  1/36 (2.78%) 
Gastrointestinal haemorrhage * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Nausea * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  2/69 (2.90%)  0/36 (0.00%) 
Small intestinal obstruction * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  0/69 (0.00%)  1/36 (2.78%) 
Abdominal compartment syndrome * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Abdominal distension * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Anal fissure * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Constipation * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Diarrhoea * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Intestinal obstruction * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Intestinal perforation * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Lower gastrointestinal haemorrhage * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Melaena * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  1/36 (2.78%) 
Rectal haemorrhage * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  1/19 (5.26%)  0/69 (0.00%)  0/36 (0.00%) 
General disorders                   
Disease progression * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  2/26 (7.69%)  1/19 (5.26%)  8/69 (11.59%)  0/36 (0.00%) 
Pyrexia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  4/26 (15.38%)  1/19 (5.26%)  2/69 (2.90%)  0/36 (0.00%) 
General physical health deterioration * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  0/69 (0.00%)  2/36 (5.56%) 
Fatigue * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Generalised oedema * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  1/19 (5.26%)  1/69 (1.45%)  0/36 (0.00%) 
Gait disturbance * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Injection site extravasation * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  1/36 (2.78%) 
Non-cardiac chest pain * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Oedema peripheral * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  1/19 (5.26%)  0/69 (0.00%)  0/36 (0.00%) 
Hepatobiliary disorders                   
Hepatic failure * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Infections and infestations                   
Sepsis * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  4/69 (5.80%)  0/36 (0.00%) 
Lung infection * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  2/69 (2.90%)  0/36 (0.00%) 
Cellulitis * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  2/69 (2.90%)  0/36 (0.00%) 
Pneumonia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  0/69 (0.00%)  1/36 (2.78%) 
Clostridium difficile colitis * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  1/36 (2.78%) 
Clostridium difficile infection * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Cytomegalovirus infection * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Enterocolitis infectious * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Influenza * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Lower respiratory tract infection * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Oesophageal candidiasis * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  1/19 (5.26%)  0/69 (0.00%)  0/36 (0.00%) 
Oropharyngeal candidiasis * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  1/19 (5.26%)  0/69 (0.00%)  0/36 (0.00%) 
Parainfluenzae virus infection * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Pneumonia haemophilus * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Pneumonia influenzal * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Pneumonia staphylococcal * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Progressive multifocal leukoencephalopathy * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  1/36 (2.78%) 
Rhinovirus infection * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Septic shock * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Staphylococcal sepsis * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Upper respiratory tract infection * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Injury, poisoning and procedural complications                   
Procedural pain * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Subdural haematoma * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Wound * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  1/19 (5.26%)  0/69 (0.00%)  0/36 (0.00%) 
Investigations                   
Alanine aminotransferase increased * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  1/36 (2.78%) 
Aspartate aminotransferase increased * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  1/36 (2.78%) 
Gamma-glutamyltransferase increased * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Platelet count decreased * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  1/19 (5.26%)  0/69 (0.00%)  0/36 (0.00%) 
Metabolism and nutrition disorders                   
Fluid overload * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  1/36 (2.78%) 
Failure to thrive * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Hypokalaemia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Hyponatraemia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  1/19 (5.26%)  0/69 (0.00%)  0/36 (0.00%) 
Musculoskeletal and connective tissue disorders                   
Muscular weakness * 1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  1/19 (5.26%)  1/69 (1.45%)  0/36 (0.00%) 
Arthralgia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Neck mass * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  1/36 (2.78%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                   
Diffuse large B-cell lymphoma * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  2/26 (7.69%)  0/19 (0.00%)  2/69 (2.90%)  0/36 (0.00%) 
Lymphoma * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  1/36 (2.78%) 
Burkitt's lymphoma * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Mantle cell lymphoma * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  1/36 (2.78%) 
Nervous system disorders                   
Aphasia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Depressed level of consciousness * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Headache * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Paraesthesia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Syncope * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Psychiatric disorders                   
Confusional state * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Disorientation * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  1/36 (2.78%) 
Mental status changes * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Renal and urinary disorders                   
Acute kidney injury * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  1/19 (5.26%)  1/69 (1.45%)  1/36 (2.78%) 
Haematuria * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Urinary retention * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Reproductive system and breast disorders                   
Oedema genital * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  1/19 (5.26%)  0/69 (0.00%)  0/36 (0.00%) 
Perineal pain * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  1/36 (2.78%) 
Scrotal pain * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  1/36 (2.78%) 
Respiratory, thoracic and mediastinal disorders                   
Pleural effusion * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  2/26 (7.69%)  0/19 (0.00%)  2/69 (2.90%)  3/36 (8.33%) 
Dyspnoea * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  1/19 (5.26%)  3/69 (4.35%)  1/36 (2.78%) 
Pneumonitis * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Pulmonary embolism * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  1/36 (2.78%) 
Hypoxia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Pneumomediastinum * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Pneumonia aspiration * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Pulmonary oedema * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Vascular disorders                   
Embolism * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Lymphoedema * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  1/19 (5.26%)  0/69 (0.00%)  0/36 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1: 15 μg/kg Q3W Part 1: 30 μg/kg Q3W Part 1: 60 μg/kg Q3W Part 1: 90 μg/kg Q3W Part 1: 120 μg/kg Q3W Part 2: 120 μg/kg Q3W Part 1: 150 μg/kg Q3W Part 2: 150 μg/kg Q3W Part 1: 200 μg/kg Q3W and Q6W
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   4/4 (100.00%)   3/4 (75.00%)   4/4 (100.00%)   5/5 (100.00%)   16/16 (100.00%)   25/26 (96.15%)   19/19 (100.00%)   65/69 (94.20%)   36/36 (100.00%) 
Blood and lymphatic system disorders                   
Anaemia * 1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  3/5 (60.00%)  1/16 (6.25%)  9/26 (34.62%)  7/19 (36.84%)  25/69 (36.23%)  14/36 (38.89%) 
Neutropenia * 1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  2/5 (40.00%)  3/16 (18.75%)  4/26 (15.38%)  3/19 (15.79%)  17/69 (24.64%)  10/36 (27.78%) 
Thrombocytopenia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  3/16 (18.75%)  6/26 (23.08%)  3/19 (15.79%)  13/69 (18.84%)  9/36 (25.00%) 
Lymphopenia * 1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  0/69 (0.00%)  1/36 (2.78%) 
Leukopenia * 1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Cardiac disorders                   
Pericardial effusion * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  3/26 (11.54%)  0/19 (0.00%)  3/69 (4.35%)  3/36 (8.33%) 
Atrial fibrillation * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  1/26 (3.85%)  2/19 (10.53%)  2/69 (2.90%)  1/36 (2.78%) 
Eye disorders                   
Periorbital oedema * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/16 (12.50%)  1/26 (3.85%)  1/19 (5.26%)  5/69 (7.25%)  0/36 (0.00%) 
Dry eye * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  3/69 (4.35%)  2/36 (5.56%) 
Visual impairment * 1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  2/69 (2.90%)  0/36 (0.00%) 
Gastrointestinal disorders                   
Nausea * 1  1/4 (25.00%)  0/4 (0.00%)  1/4 (25.00%)  1/5 (20.00%)  4/16 (25.00%)  8/26 (30.77%)  5/19 (26.32%)  22/69 (31.88%)  16/36 (44.44%) 
Constipation * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  2/5 (40.00%)  2/16 (12.50%)  9/26 (34.62%)  2/19 (10.53%)  18/69 (26.09%)  6/36 (16.67%) 
Vomiting * 1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  2/16 (12.50%)  5/26 (19.23%)  2/19 (10.53%)  15/69 (21.74%)  7/36 (19.44%) 
Diarrhoea * 1  1/4 (25.00%)  1/4 (25.00%)  0/4 (0.00%)  0/5 (0.00%)  3/16 (18.75%)  2/26 (7.69%)  3/19 (15.79%)  13/69 (18.84%)  5/36 (13.89%) 
Abdominal pain * 1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/16 (12.50%)  6/26 (23.08%)  4/19 (21.05%)  7/69 (10.14%)  7/36 (19.44%) 
Abdominal distension * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  2/26 (7.69%)  2/19 (10.53%)  4/69 (5.80%)  2/36 (5.56%) 
Abdominal pain upper * 1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/16 (0.00%)  2/26 (7.69%)  0/19 (0.00%)  5/69 (7.25%)  2/36 (5.56%) 
Dyspepsia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  2/26 (7.69%)  1/19 (5.26%)  2/69 (2.90%)  3/36 (8.33%) 
Dry mouth * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  4/69 (5.80%)  2/36 (5.56%) 
Anal incontinence * 1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  1/36 (2.78%) 
Salivary hypersecretion * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
General disorders                   
Fatigue * 1  1/4 (25.00%)  1/4 (25.00%)  2/4 (50.00%)  3/5 (60.00%)  11/16 (68.75%)  11/26 (42.31%)  8/19 (42.11%)  24/69 (34.78%)  16/36 (44.44%) 
Oedema peripheral * 1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  8/16 (50.00%)  4/26 (15.38%)  9/19 (47.37%)  22/69 (31.88%)  14/36 (38.89%) 
Pyrexia * 1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  6/26 (23.08%)  2/19 (10.53%)  8/69 (11.59%)  11/36 (30.56%) 
Asthenia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  2/26 (7.69%)  2/19 (10.53%)  2/69 (2.90%)  4/36 (11.11%) 
Face oedema * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/16 (12.50%)  1/26 (3.85%)  0/19 (0.00%)  3/69 (4.35%)  4/36 (11.11%) 
Non-cardiac chest pain * 1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  2/16 (12.50%)  0/26 (0.00%)  1/19 (5.26%)  2/69 (2.90%)  4/36 (11.11%) 
Chills * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  2/26 (7.69%)  1/19 (5.26%)  2/69 (2.90%)  3/36 (8.33%) 
Localised oedema * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/16 (12.50%)  1/26 (3.85%)  0/19 (0.00%)  4/69 (5.80%)  0/36 (0.00%) 
Pain * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  0/26 (0.00%)  0/19 (0.00%)  5/69 (7.25%)  1/36 (2.78%) 
Malaise * 1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  1/69 (1.45%)  3/36 (8.33%) 
Axillary pain * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  2/36 (5.56%) 
Immune system disorders                   
Food allergy * 1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Infections and infestations                   
Urinary tract infection * 1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  1/26 (3.85%)  1/19 (5.26%)  7/69 (10.14%)  0/36 (0.00%) 
Cellulitis * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  0/26 (0.00%)  3/19 (15.79%)  3/69 (4.35%)  0/36 (0.00%) 
Rhinitis * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  5/69 (7.25%)  1/36 (2.78%) 
Pneumonia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  1/19 (5.26%)  2/69 (2.90%)  1/36 (2.78%) 
Clostridium difficile infection * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  1/69 (1.45%)  1/36 (2.78%) 
Upper respiratory tract infection * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  2/36 (5.56%) 
Oral candidiasis * 1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  0/69 (0.00%)  1/36 (2.78%) 
Respiratory tract infection * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  0/69 (0.00%)  2/36 (5.56%) 
Clostridium difficile colitis * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  1/36 (2.78%) 
Influenza * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Sinusitis * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  2/36 (5.56%) 
Corona virus infection * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Pyelonephritis acute * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Injury, poisoning and procedural complications                   
Fall * 1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/16 (12.50%)  3/26 (11.54%)  4/19 (21.05%)  7/69 (10.14%)  0/36 (0.00%) 
Contusion * 1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  3/19 (15.79%)  2/69 (2.90%)  1/36 (2.78%) 
Skin abrasion * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  1/16 (6.25%)  0/26 (0.00%)  1/19 (5.26%)  1/69 (1.45%)  1/36 (2.78%) 
Investigations                   
Gamma-glutamyltransferase increased * 1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  4/5 (80.00%)  4/16 (25.00%)  9/26 (34.62%)  3/19 (15.79%)  19/69 (27.54%)  17/36 (47.22%) 
Blood alkaline phosphatase increased * 1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  3/5 (60.00%)  1/16 (6.25%)  5/26 (19.23%)  2/19 (10.53%)  16/69 (23.19%)  9/36 (25.00%) 
Aspartate aminotransferase increased * 1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  2/5 (40.00%)  1/16 (6.25%)  4/26 (15.38%)  1/19 (5.26%)  14/69 (20.29%)  11/36 (30.56%) 
Platelet count decreased * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  7/26 (26.92%)  3/19 (15.79%)  11/69 (15.94%)  11/36 (30.56%) 
Alanine aminotransferase increased * 1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  2/5 (40.00%)  1/16 (6.25%)  5/26 (19.23%)  3/19 (15.79%)  11/69 (15.94%)  9/36 (25.00%) 
Neutrophil count decreased * 1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  3/16 (18.75%)  3/26 (11.54%)  5/19 (26.32%)  8/69 (11.59%)  8/36 (22.22%) 
White blood cell count decreased * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/16 (12.50%)  5/26 (19.23%)  2/19 (10.53%)  4/69 (5.80%)  9/36 (25.00%) 
Lymphocyte count decreased * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  4/26 (15.38%)  1/19 (5.26%)  6/69 (8.70%)  6/36 (16.67%) 
Blood creatinine increased * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  3/26 (11.54%)  2/19 (10.53%)  2/69 (2.90%)  3/36 (8.33%) 
Weight decreased * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  2/16 (12.50%)  1/26 (3.85%)  1/19 (5.26%)  2/69 (2.90%)  3/36 (8.33%) 
Blood bilirubin increased * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  3/69 (4.35%)  3/36 (8.33%) 
Amylase increased * 1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/16 (0.00%)  2/26 (7.69%)  0/19 (0.00%)  1/69 (1.45%)  1/36 (2.78%) 
Blood cholesterol increased * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  3/26 (11.54%)  0/19 (0.00%)  0/69 (0.00%)  2/36 (5.56%) 
Lipase increased * 1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  1/69 (1.45%)  1/36 (2.78%) 
International normalised ratio increased * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  2/36 (5.56%) 
Blood bicarbonate increased * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Metabolism and nutrition disorders                   
Decreased appetite * 1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  1/5 (20.00%)  1/16 (6.25%)  6/26 (23.08%)  2/19 (10.53%)  11/69 (15.94%)  12/36 (33.33%) 
Hypokalaemia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  2/16 (12.50%)  1/26 (3.85%)  3/19 (15.79%)  12/69 (17.39%)  4/36 (11.11%) 
Hyperglycaemia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  3/26 (11.54%)  3/19 (15.79%)  7/69 (10.14%)  5/36 (13.89%) 
Hyponatraemia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  4/26 (15.38%)  1/19 (5.26%)  5/69 (7.25%)  2/36 (5.56%) 
Hypomagnesaemia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  0/26 (0.00%)  1/19 (5.26%)  8/69 (11.59%)  2/36 (5.56%) 
Dehydration * 1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  2/69 (2.90%)  6/36 (16.67%) 
Hypocalcaemia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  2/26 (7.69%)  1/19 (5.26%)  3/69 (4.35%)  3/36 (8.33%) 
Hypertriglyceridaemia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  2/26 (7.69%)  1/19 (5.26%)  2/69 (2.90%)  4/36 (11.11%) 
Hypoalbuminaemia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  2/26 (7.69%)  0/19 (0.00%)  4/69 (5.80%)  3/36 (8.33%) 
Hypophosphataemia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  2/26 (7.69%)  0/19 (0.00%)  1/69 (1.45%)  2/36 (5.56%) 
Hypercalcaemia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  2/69 (2.90%)  0/36 (0.00%) 
Hyperuricaemia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  2/36 (5.56%) 
Gout * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Musculoskeletal and connective tissue disorders                   
Myalgia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  3/16 (18.75%)  1/26 (3.85%)  1/19 (5.26%)  3/69 (4.35%)  9/36 (25.00%) 
Back pain * 1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  4/26 (15.38%)  3/19 (15.79%)  5/69 (7.25%)  1/36 (2.78%) 
Pain in extremity * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  2/26 (7.69%)  1/19 (5.26%)  7/69 (10.14%)  3/36 (8.33%) 
Muscular weakness * 1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  0/26 (0.00%)  2/19 (10.53%)  4/69 (5.80%)  2/36 (5.56%) 
Arthralgia * 1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  2/16 (12.50%)  1/26 (3.85%)  0/19 (0.00%)  0/69 (0.00%)  4/36 (11.11%) 
Musculoskeletal pain * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/16 (12.50%)  0/26 (0.00%)  1/19 (5.26%)  4/69 (5.80%)  1/36 (2.78%) 
Neck pain * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  2/19 (10.53%)  2/69 (2.90%)  2/36 (5.56%) 
Bone pain * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  2/36 (5.56%) 
Joint swelling * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  2/69 (2.90%)  0/36 (0.00%) 
Limb mass * 1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Muscle twitching * 1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Nervous system disorders                   
Dizziness * 1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  5/26 (19.23%)  4/19 (21.05%)  5/69 (7.25%)  4/36 (11.11%) 
Headache * 1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/16 (12.50%)  3/26 (11.54%)  2/19 (10.53%)  4/69 (5.80%)  5/36 (13.89%) 
Dysgeusia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  1/26 (3.85%)  0/19 (0.00%)  2/69 (2.90%)  2/36 (5.56%) 
Neuropathy peripheral * 1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  0/26 (0.00%)  0/19 (0.00%)  2/69 (2.90%)  1/36 (2.78%) 
Peripheral sensory neuropathy * 1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  1/16 (6.25%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  1/36 (2.78%) 
Psychiatric disorders                   
Insomnia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/16 (12.50%)  2/26 (7.69%)  1/19 (5.26%)  4/69 (5.80%)  4/36 (11.11%) 
Anxiety * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  1/26 (3.85%)  0/19 (0.00%)  1/69 (1.45%)  3/36 (8.33%) 
Renal and urinary disorders                   
Bladder spasm * 1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Urinary retention * 1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Reproductive system and breast disorders                   
Breast oedema * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Dyspnoea * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  4/16 (25.00%)  7/26 (26.92%)  4/19 (21.05%)  15/69 (21.74%)  7/36 (19.44%) 
Pleural effusion * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  2/5 (40.00%)  4/16 (25.00%)  4/26 (15.38%)  3/19 (15.79%)  15/69 (21.74%)  8/36 (22.22%) 
Cough * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  3/16 (18.75%)  7/26 (26.92%)  2/19 (10.53%)  14/69 (20.29%)  8/36 (22.22%) 
Nasal congestion * 1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  1/16 (6.25%)  2/26 (7.69%)  1/19 (5.26%)  2/69 (2.90%)  3/36 (8.33%) 
Productive cough * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  2/16 (12.50%)  1/26 (3.85%)  1/19 (5.26%)  3/69 (4.35%)  1/36 (2.78%) 
Oropharyngeal pain * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  2/26 (7.69%)  2/19 (10.53%)  1/69 (1.45%)  0/36 (0.00%) 
Chronic obstructive pulmonary disease * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Organising pneumonia * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Pulmonary oedema * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Sinus congestion * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Skin and subcutaneous tissue disorders                   
Rash * 1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  1/5 (20.00%)  3/16 (18.75%)  4/26 (15.38%)  8/19 (42.11%)  19/69 (27.54%)  9/36 (25.00%) 
Erythema * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  2/16 (12.50%)  3/26 (11.54%)  2/19 (10.53%)  9/69 (13.04%)  4/36 (11.11%) 
Pruritus * 1  1/4 (25.00%)  0/4 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  2/16 (12.50%)  2/26 (7.69%)  2/19 (10.53%)  5/69 (7.25%)  7/36 (19.44%) 
Rash maculo-papular * 1  1/4 (25.00%)  0/4 (0.00%)  2/4 (50.00%)  0/5 (0.00%)  3/16 (18.75%)  1/26 (3.85%)  2/19 (10.53%)  5/69 (7.25%)  5/36 (13.89%) 
Skin hyperpigmentation * 1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  3/16 (18.75%)  0/26 (0.00%)  2/19 (10.53%)  3/69 (4.35%)  4/36 (11.11%) 
Photosensitivity reaction * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  3/16 (18.75%)  1/26 (3.85%)  1/19 (5.26%)  2/69 (2.90%)  3/36 (8.33%) 
Dry skin * 1  1/4 (25.00%)  0/4 (0.00%)  1/4 (25.00%)  1/5 (20.00%)  1/16 (6.25%)  2/26 (7.69%)  0/19 (0.00%)  1/69 (1.45%)  2/36 (5.56%) 
Dermatitis bullous * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  2/19 (10.53%)  1/69 (1.45%)  4/36 (11.11%) 
Rash pruritic * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  1/26 (3.85%)  2/19 (10.53%)  2/69 (2.90%)  3/36 (8.33%) 
Night sweats * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  2/26 (7.69%)  1/19 (5.26%)  2/69 (2.90%)  1/36 (2.78%) 
Skin ulcer * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  2/36 (5.56%) 
Decubitus ulcer * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  1/36 (2.78%) 
Pruritus generalised * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  1/26 (3.85%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Rash macular * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  1/19 (5.26%)  0/69 (0.00%)  0/36 (0.00%) 
Skin lesion * 1  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  1/69 (1.45%)  0/36 (0.00%) 
Dermatitis acneiform * 1  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Drug eruption * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/5 (20.00%)  0/16 (0.00%)  0/26 (0.00%)  0/19 (0.00%)  0/69 (0.00%)  0/36 (0.00%) 
Vascular disorders                   
Hypertension * 1  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/5 (0.00%)  2/16 (12.50%)  3/26 (11.54%)  0/19 (0.00%)  4/69 (5.80%)  4/36 (11.11%) 
Hypotension * 1  2/4 (50.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  1/16 (6.25%)  3/26 (11.54%)  1/19 (5.26%)  3/69 (4.35%)  4/36 (11.11%) 
Flushing * 1  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/5 (0.00%)  0/16 (0.00%)  3/26 (11.54%)  1/19 (5.26%)  3/69 (4.35%)  0/36 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
PI can publish after first multi-site publication, or if no multi-site publication is made within 18 months of study completion/termination. The only disclosure restriction on the PI is the sponsor can review results comms. prior to public release and can embargo comms. regarding trial results for a period that is more than 60 but less than or equal to 180 days from the time submitted to sponsor for review. The sponsor can't require changes to the communication and can't extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: ADC Therapeutics
Organization: ADC Therapeutics
Phone: 954-903-7994
EMail: clinical.trials@adctherapeutics.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: ADC Therapeutics S.A.
ClinicalTrials.gov Identifier: NCT02669017    
Other Study ID Numbers: ADCT-402-101
2016-000952-92 ( EudraCT Number )
First Submitted: January 21, 2016
First Posted: January 29, 2016
Results First Submitted: February 19, 2020
Results First Posted: April 13, 2020
Last Update Posted: May 19, 2021