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Study of CB-103 in Adult Patients With Advanced or Metastatic Solid Tumours and Haematological Malignancies

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: NCT03422679
Recruitment Status : Terminated (business reason)
First Posted : February 6, 2018
Results First Posted : January 16, 2024
Last Update Posted : January 16, 2024
Sponsor:
Information provided by (Responsible Party):
Cellestia Biotech AG

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Cancer
Colorectal Cancer
Adenoid Cystic Carcinoma
Non-hodgkin Lymphoma
Glomus Tumor, Malignant
Hepatocellular Carcinoma
Osteosarcoma
T-ALL
Intervention Drug: CB-103
Enrollment 79
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Cohort 7 Cohort 8 Cohort 9 Cohort 10 Cohort 11 Cohort 12 Confirmatory Cohort
Hide Arm/Group Description CB-103 13mg once daily. CB-103 26mg once daily CB-103 52mg once daily CB-103 104mg once daily CB-103 148mg once daily CB-103 217mg once daily CB-103 348mg once daily CB-103 522mg once daily CB-103 250mg twice daily CB-103 300mg twice daily, 5 days on, 2 days off CB-103 400mg twice daily, 5 days on, 2 days off CB-103 500mg twice daily, 5 days on, 2 days off CB-103 500mg once daily
Period Title: Overall Study
Started [1] 5 3 7 7 3 4 3 9 5 6 4 8 15
Completed [1] 5 3 7 7 3 4 3 9 5 6 4 8 15
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0
[1]
Part A - dose escalation was completed. Part B - dose expansion was never opened.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Cohort 7 Cohort 8 Cohort 9 Cohort 10 Cohort 11 Cohort 12 Confirmatory Cohort Total
Hide Arm/Group Description CB-103 13mg once daily CB-103 26mg once daily CB-103 52mg once daily CB-103 104mg once daily CB-103 148mg once daily CB-103 217mg once daily CB-103 348mg once daily CB-103 522mg once daily CB-103 250mg twice daily CB-103 300mg twice daily, 5 days on, 2 days off CB-103 400mg twice daily, 5 days on, 2 days off CB-103 500mg twice daily, 5 days on, 2 days off CB-103 500mg once daily Total of all reporting groups
Overall Number of Baseline Participants 5 3 7 7 3 4 3 9 5 6 4 8 15 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 7 participants 7 participants 3 participants 4 participants 3 participants 9 participants 5 participants 6 participants 4 participants 8 participants 15 participants 79 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  60.0%
3
 100.0%
4
  57.1%
5
  71.4%
3
 100.0%
3
  75.0%
2
  66.7%
5
  55.6%
3
  60.0%
5
  83.3%
3
  75.0%
4
  50.0%
12
  80.0%
55
  69.6%
>=65 years
2
  40.0%
0
   0.0%
3
  42.9%
2
  28.6%
0
   0.0%
1
  25.0%
1
  33.3%
4
  44.4%
2
  40.0%
1
  16.7%
1
  25.0%
4
  50.0%
3
  20.0%
24
  30.4%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants 3 participants 7 participants 7 participants 3 participants 4 participants 3 participants 9 participants 5 participants 6 participants 4 participants 8 participants 15 participants 79 participants
57.2
(39 to 74)
55.7
(39 to 74)
52.7
(25 to 67)
54.4
(38 to 70)
51.3
(44 to 62)
54.8
(41 to 69)
61.7
(49 to 76)
56.6
(28 to 76)
64.6
(56 to 75)
54
(42 to 72)
51.5
(23 to 74)
58.6
(25 to 75)
46.9
(23 to 71)
54.4
(23 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 7 participants 7 participants 3 participants 4 participants 3 participants 9 participants 5 participants 6 participants 4 participants 8 participants 15 participants 79 participants
Female
1
  20.0%
1
  33.3%
3
  42.9%
3
  42.9%
3
 100.0%
2
  50.0%
2
  66.7%
5
  55.6%
2
  40.0%
4
  66.7%
1
  25.0%
2
  25.0%
5
  33.3%
34
  43.0%
Male
4
  80.0%
2
  66.7%
4
  57.1%
4
  57.1%
0
   0.0%
2
  50.0%
1
  33.3%
4
  44.4%
3
  60.0%
2
  33.3%
3
  75.0%
6
  75.0%
10
  66.7%
45
  57.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 7 participants 7 participants 3 participants 4 participants 3 participants 9 participants 5 participants 6 participants 4 participants 8 participants 15 participants 79 participants
American Indian or Alaska 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%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
6
  40.0%
7
   8.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
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
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.3%
White
5
 100.0%
3
 100.0%
7
 100.0%
7
 100.0%
2
  66.7%
4
 100.0%
3
 100.0%
9
 100.0%
4
  80.0%
6
 100.0%
4
 100.0%
7
  87.5%
9
  60.0%
70
  88.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
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
   1.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 5 participants 3 participants 7 participants 7 participants 3 participants 4 participants 3 participants 9 participants 5 participants 6 participants 4 participants 8 participants 15 participants 79 participants
South Korea 0 0 0 0 0 0 0 0 0 0 0 0 9 9
United States 0 0 0 0 0 0 0 0 1 2 2 5 3 13
Switzerland 1 2 3 3 0 0 1 4 1 0 0 0 0 15
Germany 0 0 0 0 0 0 0 0 0 1 2 1 1 5
Spain 4 1 4 4 3 4 2 5 3 3 0 2 2 37
1.Primary Outcome
Title Dose Limiting Toxicity (DLT)
Hide Description

Number of patients with dose limiting toxicity during the first cycle.

DLT is defined as a severe adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications, that occurs ≤ 28 days following the first dose of CB-103 (Cycle 1).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Cohort 7 Cohort 8 Cohort 9 Cohort 10 Cohort 11 Cohort 12 Confirmatory Cohort
Hide Arm/Group Description:
CB-103 13mg once daily
CB-103 26mg once daily
CB-103 52mg once daily
CB-103 104mg once daily
CB-103 148mg once daily
CB-103 217mg once daily
CB-103 348mg once daily
CB-103 522mg once daily
CB-103 250mg twice daily
CB-103 300mg twice daily, 5 days on, 2 days off
CB-103 400mg twice daily, 5 days on, 2 days off
CB-103 500mg twice daily, 5 days, 2 days off
CB-103 500mg once daily
Overall Number of Participants Analyzed 5 3 7 7 3 4 3 9 5 6 4 8 15
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Overall Response Rate
Hide Description Number of patients with an overall response rate (CR+PR assessed by RECSIT v1.1 or CR or CRi by NCCN guidelines) up to 24 months
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Cohort 7 Cohort 8 Cohort 9 Cohort 10 Cohort 11 Cohort 12 Confirmatory Cohort
Hide Arm/Group Description:
CB-103 13mg once daily
CB-103 26mg once daily
CB-103 52mg once daily
CB-103 104mg once daily
CB-103 148mg once daily
CB-103 217mg once daily
CB-103 348mg once daily
CB-103 522mg once daily
CB-103 250mg twice daily
CB-103 300mg twice daily, 5 days on, 2 days off
CB-103 400mg twice daily, 5 days on, 2 days off
CB-103 500mg twice daily, 5 days, 2 days off
CB-103 500mg once daily
Overall Number of Participants Analyzed 5 3 7 7 3 4 3 9 5 6 4 8 15
Measure Type: Count of Participants
Unit of Measure: Participants
1
  20.0%
2
  66.7%
5
  71.4%
5
  71.4%
2
  66.7%
1
  25.0%
2
  66.7%
4
  44.4%
2
  40.0%
5
  83.3%
1
  25.0%
4
  50.0%
3
  20.0%
Time Frame From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
Adverse Event Reporting Description The occurrence of the adverse events was sought by questioning of the patient at each visit during the study. Adverse events also may be detected when they are volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
 
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Cohort 7 Cohort 8 Cohort 9 Cohort 10 Cohort 11 Cohort 12 Confirmatory Cohort
Hide Arm/Group Description CB-103 13mg once daily CB-103 26mg once daily CB-103 52mg once daily CB-103 104mg once daily CB-103 148mg once daily CB-103 217mg once daily CB-103 348mg once daily CB-103 522mg once daily CB-103 250mg twice daily CB-103 300mg twice daily, 5 days on, 2 days off CB-103 400mg twice daily, 5 days on, 2 days off CB-103 500mg twice daily, 5 days on, 2 days off CB-103 500mg once daily
All-Cause Mortality
Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Cohort 7 Cohort 8 Cohort 9 Cohort 10 Cohort 11 Cohort 12 Confirmatory Cohort
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)      0/3 (0.00%)      0/7 (0.00%)      0/7 (0.00%)      0/3 (0.00%)      0/4 (0.00%)      0/3 (0.00%)      0/9 (0.00%)      0/5 (0.00%)      0/6 (0.00%)      0/4 (0.00%)      0/8 (0.00%)      0/15 (0.00%)    
Hide Serious Adverse Events
Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Cohort 7 Cohort 8 Cohort 9 Cohort 10 Cohort 11 Cohort 12 Confirmatory Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/3 (0.00%)      0/7 (0.00%)      1/7 (14.29%)      0/3 (0.00%)      0/4 (0.00%)      0/3 (0.00%)      0/9 (0.00%)      1/5 (20.00%)      0/6 (0.00%)      0/4 (0.00%)      0/8 (0.00%)      1/15 (6.67%)    
Hepatobiliary disorders                           
Liver Function Test Increased †  0/5 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0 1/15 (6.67%)  1
Drug Induced Liver Injury †  0/5 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0 0/15 (0.00%)  0
Skin and subcutaneous tissue disorders                           
Steven-Johnson Syndrome †  0/5 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0 0/15 (0.00%)  0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Cohort 7 Cohort 8 Cohort 9 Cohort 10 Cohort 11 Cohort 12 Confirmatory Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/5 (60.00%)      2/3 (66.67%)      5/7 (71.43%)      4/7 (57.14%)      2/3 (66.67%)      3/4 (75.00%)      3/3 (100.00%)      7/9 (77.78%)      4/5 (80.00%)      6/6 (100.00%)      4/4 (100.00%)      7/8 (87.50%)      9/15 (60.00%)    
Blood and lymphatic system disorders                           
anaemia †  0/5 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  2 1/9 (11.11%)  4 2/5 (40.00%)  6 2/6 (33.33%)  4 2/4 (50.00%)  8 3/8 (37.50%)  13 2/15 (13.33%)  2
Eye disorders                           
dyschromatopsia †  0/5 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 2/9 (22.22%)  2 1/5 (20.00%)  2 5/6 (83.33%)  6 3/4 (75.00%)  3 3/8 (37.50%)  4 1/15 (6.67%)  1
vision blurred †  0/5 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 1/3 (33.33%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0 2/9 (22.22%)  2 1/5 (20.00%)  1 2/6 (33.33%)  2 0/4 (0.00%)  0 3/8 (37.50%)  3 1/15 (6.67%)  1
Gastrointestinal disorders                           
Nausea †  2/5 (40.00%)  2 1/3 (33.33%)  1 2/7 (28.57%)  2 2/7 (28.57%)  3 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 2/9 (22.22%)  4 1/5 (20.00%)  1 2/6 (33.33%)  2 0/4 (0.00%)  0 1/8 (12.50%)  1 3/15 (20.00%)  4
dyspepsia †  0/5 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 3/9 (33.33%)  3 0/5 (0.00%)  0 2/6 (33.33%)  2 0/4 (0.00%)  0 1/8 (12.50%)  1 2/15 (13.33%)  2
diarrhoea †  1/5 (20.00%)  1 0/3 (0.00%)  0 3/7 (42.86%)  3 1/7 (14.29%)  3 0/3 (0.00%)  0 1/4 (25.00%)  2 0/3 (0.00%)  0 2/9 (22.22%)  3 0/5 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 1/8 (12.50%)  1 0/15 (0.00%)  0
vomiting †  0/5 (0.00%)  0 0/3 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/3 (33.33%)  2 0/4 (0.00%)  0 0/3 (0.00%)  0 2/9 (22.22%)  4 1/5 (20.00%)  1 2/6 (33.33%)  2 1/4 (25.00%)  1 2/8 (25.00%)  2 2/15 (13.33%)  2
General disorders                           
fatigue †  1/5 (20.00%)  1 1/3 (33.33%)  1 1/7 (14.29%)  1 0/7 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 1/9 (11.11%)  1 1/5 (20.00%)  1 1/6 (16.67%)  2 2/4 (50.00%)  2 0/8 (0.00%)  0 0/15 (0.00%)  0
†
Indicates events were collected by 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.
Partners shall provide to Cellestia any proposed publication or oral pesentation relating to the study or the study drug or the results at least 60 days prior to the intended submission or presentation of the publication to allow Cellestia to review it. If Cellestia doesn't provide any comments within the sixty day period, Partner are free to publish.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Maria Bobadilla, Chief Development Officer
Organization: Cellestia Biotech AG
Phone: +41616332957
EMail: maria.bobadilla@cellestia.com
Publications:
Layout table for additonal information
Responsible Party: Cellestia Biotech AG
ClinicalTrials.gov Identifier: NCT03422679    
Other Study ID Numbers: CB103-C-101
First Submitted: January 19, 2018
First Posted: February 6, 2018
Results First Submitted: October 23, 2023
Results First Posted: January 16, 2024
Last Update Posted: January 16, 2024