Trial Outcomes & Findings for Study of CB-103 in Adult Patients With Advanced or Metastatic Solid Tumours and Haematological Malignancies (NCT NCT03422679)
NCT ID: NCT03422679
Last Updated: 2024-01-16
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
79 participants
Primary outcome timeframe
28 days
Results posted on
2024-01-16
Participant Flow
Participant milestones
| Measure |
Cohort 1
CB-103 13mg once daily.
|
Cohort 2
CB-103 26mg once daily
|
Cohort 3
CB-103 52mg once daily
|
Cohort 4
CB-103 104mg once daily
|
Cohort 5
CB-103 148mg once daily
|
Cohort 6
CB-103 217mg once daily
|
Cohort 7
CB-103 348mg once daily
|
Cohort 8
CB-103 522mg once daily
|
Cohort 9
CB-103 250mg twice daily
|
Cohort 10
CB-103 300mg twice daily, 5 days on, 2 days off
|
Cohort 11
CB-103 400mg twice daily, 5 days on, 2 days off
|
Cohort 12
CB-103 500mg twice daily, 5 days on, 2 days off
|
Confirmatory Cohort
CB-103 500mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
7
|
7
|
3
|
4
|
3
|
9
|
5
|
6
|
4
|
8
|
15
|
|
Overall Study
COMPLETED
|
5
|
3
|
7
|
7
|
3
|
4
|
3
|
9
|
5
|
6
|
4
|
8
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of CB-103 in Adult Patients With Advanced or Metastatic Solid Tumours and Haematological Malignancies
Baseline characteristics by cohort
| Measure |
Cohort 1
n=5 Participants
CB-103 13mg once daily
|
Cohort 2
n=3 Participants
CB-103 26mg once daily
|
Cohort 3
n=7 Participants
CB-103 52mg once daily
|
Cohort 4
n=7 Participants
CB-103 104mg once daily
|
Cohort 5
n=3 Participants
CB-103 148mg once daily
|
Cohort 6
n=4 Participants
CB-103 217mg once daily
|
Cohort 7
n=3 Participants
CB-103 348mg once daily
|
Cohort 8
n=9 Participants
CB-103 522mg once daily
|
Cohort 9
n=5 Participants
CB-103 250mg twice daily
|
Cohort 10
n=6 Participants
CB-103 300mg twice daily, 5 days on, 2 days off
|
Cohort 11
n=4 Participants
CB-103 400mg twice daily, 5 days on, 2 days off
|
Cohort 12
n=8 Participants
CB-103 500mg twice daily, 5 days on, 2 days off
|
Confirmatory Cohort
n=15 Participants
CB-103 500mg once daily
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
5 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=62 Participants
|
3 Participants
n=95 Participants
|
4 Participants
n=129 Participants
|
12 Participants
n=36 Participants
|
55 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
4 Participants
n=129 Participants
|
3 Participants
n=36 Participants
|
24 Participants
n=36 Participants
|
|
Age, Continuous
|
57.2 years
n=93 Participants
|
55.7 years
n=4 Participants
|
52.7 years
n=27 Participants
|
54.4 years
n=483 Participants
|
51.3 years
n=36 Participants
|
54.8 years
n=10 Participants
|
61.7 years
n=115 Participants
|
56.6 years
n=40 Participants
|
64.6 years
n=8 Participants
|
54 years
n=62 Participants
|
51.5 years
n=95 Participants
|
58.6 years
n=129 Participants
|
46.9 years
n=36 Participants
|
54.4 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
5 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
2 Participants
n=129 Participants
|
5 Participants
n=36 Participants
|
34 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=62 Participants
|
3 Participants
n=95 Participants
|
6 Participants
n=129 Participants
|
10 Participants
n=36 Participants
|
45 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
1 Participants
n=129 Participants
|
6 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
9 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=62 Participants
|
4 Participants
n=95 Participants
|
7 Participants
n=129 Participants
|
9 Participants
n=36 Participants
|
70 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
|
Region of Enrollment
South Korea
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=40 Participants
|
0 participants
n=8 Participants
|
0 participants
n=62 Participants
|
0 participants
n=95 Participants
|
0 participants
n=129 Participants
|
9 participants
n=36 Participants
|
9 participants
n=36 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=40 Participants
|
1 participants
n=8 Participants
|
2 participants
n=62 Participants
|
2 participants
n=95 Participants
|
5 participants
n=129 Participants
|
3 participants
n=36 Participants
|
13 participants
n=36 Participants
|
|
Region of Enrollment
Switzerland
|
1 participants
n=93 Participants
|
2 participants
n=4 Participants
|
3 participants
n=27 Participants
|
3 participants
n=483 Participants
|
0 participants
n=36 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
4 participants
n=40 Participants
|
1 participants
n=8 Participants
|
0 participants
n=62 Participants
|
0 participants
n=95 Participants
|
0 participants
n=129 Participants
|
0 participants
n=36 Participants
|
15 participants
n=36 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=40 Participants
|
0 participants
n=8 Participants
|
1 participants
n=62 Participants
|
2 participants
n=95 Participants
|
1 participants
n=129 Participants
|
1 participants
n=36 Participants
|
5 participants
n=36 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=93 Participants
|
1 participants
n=4 Participants
|
4 participants
n=27 Participants
|
4 participants
n=483 Participants
|
3 participants
n=36 Participants
|
4 participants
n=10 Participants
|
2 participants
n=115 Participants
|
5 participants
n=40 Participants
|
3 participants
n=8 Participants
|
3 participants
n=62 Participants
|
0 participants
n=95 Participants
|
2 participants
n=129 Participants
|
2 participants
n=36 Participants
|
37 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 28 daysNumber 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).
Outcome measures
| Measure |
Cohort 1
n=5 Participants
CB-103 13mg once daily
|
Cohort 2
n=3 Participants
CB-103 26mg once daily
|
Cohort 3
n=7 Participants
CB-103 52mg once daily
|
Cohort 4
n=7 Participants
CB-103 104mg once daily
|
Cohort 5
n=3 Participants
CB-103 148mg once daily
|
Cohort 6
n=4 Participants
CB-103 217mg once daily
|
Cohort 7
n=3 Participants
CB-103 348mg once daily
|
Cohort 8
n=9 Participants
CB-103 522mg once daily
|
Cohort 9
n=5 Participants
CB-103 250mg twice daily
|
Cohort 10
n=6 Participants
CB-103 300mg twice daily, 5 days on, 2 days off
|
Cohort 11
n=4 Participants
CB-103 400mg twice daily, 5 days on, 2 days off
|
Cohort 12
n=8 Participants
CB-103 500mg twice daily, 5 days, 2 days off
|
Confirmatory Cohort
n=15 Participants
CB-103 500mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 monthsNumber 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
Outcome measures
| Measure |
Cohort 1
n=5 Participants
CB-103 13mg once daily
|
Cohort 2
n=3 Participants
CB-103 26mg once daily
|
Cohort 3
n=7 Participants
CB-103 52mg once daily
|
Cohort 4
n=7 Participants
CB-103 104mg once daily
|
Cohort 5
n=3 Participants
CB-103 148mg once daily
|
Cohort 6
n=4 Participants
CB-103 217mg once daily
|
Cohort 7
n=3 Participants
CB-103 348mg once daily
|
Cohort 8
n=9 Participants
CB-103 522mg once daily
|
Cohort 9
n=5 Participants
CB-103 250mg twice daily
|
Cohort 10
n=6 Participants
CB-103 300mg twice daily, 5 days on, 2 days off
|
Cohort 11
n=4 Participants
CB-103 400mg twice daily, 5 days on, 2 days off
|
Cohort 12
n=8 Participants
CB-103 500mg twice daily, 5 days, 2 days off
|
Confirmatory Cohort
n=15 Participants
CB-103 500mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate
|
1 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 4
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 5
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 6
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 7
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 8
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 9
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 10
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 11
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 12
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Confirmatory Cohort
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=5 participants at risk
CB-103 13mg once daily
|
Cohort 2
n=3 participants at risk
CB-103 26mg once daily
|
Cohort 3
n=7 participants at risk
CB-103 52mg once daily
|
Cohort 4
n=7 participants at risk
CB-103 104mg once daily
|
Cohort 5
n=3 participants at risk
CB-103 148mg once daily
|
Cohort 6
n=4 participants at risk
CB-103 217mg once daily
|
Cohort 7
n=3 participants at risk
CB-103 348mg once daily
|
Cohort 8
n=9 participants at risk
CB-103 522mg once daily
|
Cohort 9
n=5 participants at risk
CB-103 250mg twice daily
|
Cohort 10
n=6 participants at risk
CB-103 300mg twice daily, 5 days on, 2 days off
|
Cohort 11
n=4 participants at risk
CB-103 400mg twice daily, 5 days on, 2 days off
|
Cohort 12
n=8 participants at risk
CB-103 500mg twice daily, 5 days on, 2 days off
|
Confirmatory Cohort
n=15 participants at risk
CB-103 500mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Liver Function Test Increased
|
0.00%
0/5 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/7 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/7 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/4 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/9 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/5 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/6 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/4 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/8 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
6.7%
1/15 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
|
Skin and subcutaneous tissue disorders
Steven-Johnson Syndrome
|
0.00%
0/5 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/7 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/7 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/4 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/9 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
20.0%
1/5 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/6 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/4 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/8 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/15 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
|
Hepatobiliary disorders
Drug Induced Liver Injury
|
0.00%
0/5 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/7 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
14.3%
1/7 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/4 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/9 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/5 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/6 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/4 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/8 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/15 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
Other adverse events
| Measure |
Cohort 1
n=5 participants at risk
CB-103 13mg once daily
|
Cohort 2
n=3 participants at risk
CB-103 26mg once daily
|
Cohort 3
n=7 participants at risk
CB-103 52mg once daily
|
Cohort 4
n=7 participants at risk
CB-103 104mg once daily
|
Cohort 5
n=3 participants at risk
CB-103 148mg once daily
|
Cohort 6
n=4 participants at risk
CB-103 217mg once daily
|
Cohort 7
n=3 participants at risk
CB-103 348mg once daily
|
Cohort 8
n=9 participants at risk
CB-103 522mg once daily
|
Cohort 9
n=5 participants at risk
CB-103 250mg twice daily
|
Cohort 10
n=6 participants at risk
CB-103 300mg twice daily, 5 days on, 2 days off
|
Cohort 11
n=4 participants at risk
CB-103 400mg twice daily, 5 days on, 2 days off
|
Cohort 12
n=8 participants at risk
CB-103 500mg twice daily, 5 days on, 2 days off
|
Confirmatory Cohort
n=15 participants at risk
CB-103 500mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Number of events 2 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
33.3%
1/3 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
28.6%
2/7 • Number of events 2 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
28.6%
2/7 • Number of events 3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/4 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
33.3%
1/3 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
22.2%
2/9 • Number of events 4 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
20.0%
1/5 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
33.3%
2/6 • Number of events 2 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/4 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
12.5%
1/8 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
20.0%
3/15 • Number of events 4 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
|
Eye disorders
dyschromatopsia
|
0.00%
0/5 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/7 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/7 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/4 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
22.2%
2/9 • Number of events 2 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
20.0%
1/5 • Number of events 2 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
83.3%
5/6 • Number of events 6 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
75.0%
3/4 • Number of events 3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
37.5%
3/8 • Number of events 4 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
6.7%
1/15 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
|
Blood and lymphatic system disorders
anaemia
|
0.00%
0/5 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/7 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/7 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/4 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
33.3%
1/3 • Number of events 2 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
11.1%
1/9 • Number of events 4 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
40.0%
2/5 • Number of events 6 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
33.3%
2/6 • Number of events 4 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
50.0%
2/4 • Number of events 8 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
37.5%
3/8 • Number of events 13 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
13.3%
2/15 • Number of events 2 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
|
Eye disorders
vision blurred
|
0.00%
0/5 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/7 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
14.3%
1/7 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
33.3%
1/3 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
25.0%
1/4 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
22.2%
2/9 • Number of events 2 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
20.0%
1/5 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
33.3%
2/6 • Number of events 2 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/4 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
37.5%
3/8 • Number of events 3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
6.7%
1/15 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/5 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
14.3%
1/7 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/7 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
25.0%
1/4 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
33.3%
3/9 • Number of events 3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/5 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
33.3%
2/6 • Number of events 2 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/4 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
12.5%
1/8 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
13.3%
2/15 • Number of events 2 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
|
Gastrointestinal disorders
diarrhoea
|
20.0%
1/5 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
42.9%
3/7 • Number of events 3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
14.3%
1/7 • Number of events 3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
25.0%
1/4 • Number of events 2 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
22.2%
2/9 • Number of events 3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/5 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
16.7%
1/6 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/4 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
12.5%
1/8 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/15 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
|
General disorders
fatigue
|
20.0%
1/5 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
33.3%
1/3 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
14.3%
1/7 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/7 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/4 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
33.3%
1/3 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
11.1%
1/9 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
20.0%
1/5 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
16.7%
1/6 • Number of events 2 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
50.0%
2/4 • Number of events 2 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/8 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/15 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/5 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/7 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/7 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
33.3%
1/3 • Number of events 2 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/4 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
0.00%
0/3 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
22.2%
2/9 • Number of events 4 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
20.0%
1/5 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
33.3%
2/6 • Number of events 2 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
25.0%
1/4 • Number of events 1 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
25.0%
2/8 • Number of events 2 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
13.3%
2/15 • Number of events 2 • From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months
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.
|
Additional Information
Maria Bobadilla, Chief Development Officer
Cellestia Biotech AG
Phone: +41616332957
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER