Trial Outcomes & Findings for Study Assessing Safety and Efficacy of Combination of BL-8040 and Pembrolizumab in Metastatic Pancreatic Cancer Patients (NCT NCT02826486)
NCT ID: NCT02826486
Last Updated: 2024-08-28
Results Overview
Response is determined by assessment of target lesions identified in CT or MRI imaging. The ORR is assessed according to RECIST 1.1, defined as the sum of PRs (Partial Responses) and CRs (Complete Responses) determined according to best response RECIST 1.1 criteria. PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. CR is defined as disappearance of all target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Change in response between screening, end of monotherapy (Day 5), end of cycle 2 (Day 28) and approximately every 63 days until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Results posted on
2024-08-28
Participant Flow
Cohort 1 - Total of 37 subjects were enrolled into the study at sites in Israel, South Korea and the US. Cohort 2 - Total of 43 subjects were enrolled into the study at sites in Israel, Spain and the US.
Participant milestones
| Measure |
Cohort 1: BL-8040 + Pembrolizumab
Monotherapy: BL-8040 1.25 mg/kg subcutaneous (SC) injections daily on Days 1-5 of Week 1 of treatment.
Combination Therapy: Combination therapy period begins following monotherapy treatment and consists of:
* Pembrolizumab (Keytruda®) 200 mg once every three weeks (given as a 30 minute IV infusion)
* Beginning on Day 10, BL-8040 three times a week (given as SC injections)
|
Cohort 2: BL-8040 + Pembrolizumab + Chemotherapy
Monotherapy: BL-8040 1.25 mg/kg subcutaneous (SC) injections daily on Days 1-5 of Week 1 of treatment.
Combination therapy: Combination therapy period begins following monotherapy treatment and consists of:
* Chemotherapy: IV Onivyde® 70 mg/m2 over 90 minutes, followed by IV leucovorin (LV) 400 mg/m2 over 30 minutes or according to local standard, followed by IV fluorouracil (5-FU) 2400 mg/m2 over 46 hours, every 2 weeks.
* Pembrolizumab (Keytruda®) 200 mg once every three weeks (given as a 30 minute IV infusion).
* Beginning on Day 10, BL-8040 twice a week and following the chemotherapy dosing (given by SC injections).
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
43
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
37
|
43
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Assessing Safety and Efficacy of Combination of BL-8040 and Pembrolizumab in Metastatic Pancreatic Cancer Patients
Baseline characteristics by cohort
| Measure |
Cohort 1: BL-8040 + Pembrolizumab
n=37 Participants
Monotherapy: BL-8040 1.25 mg/kg subcutaneous (SC) injections daily on Days 1-5 of Week 1 of treatment.
Combination Therapy: Combination therapy period begins following monotherapy treatment and consists of:
* Pembrolizumab (Keytruda®) 200 mg once every three weeks (given as a 30 minute IV infusion)
* Beginning on Day 10, BL-8040 three times a week (given as SC injections)
|
BL-8040 + Pembrolizumab + Chemotherapy
n=43 Participants
Monotherapy: BL-8040 1.25 mg/kg subcutaneous (SC) injections daily on Days 1-5 of Week 1 of treatment.
Combination Therapy: Combination therapy period begins following monotherapy treatment and consists of:
* Chemotherapy: IV Onivyde® 70 mg/m2 over 90 minutes followed by IV leucovorin (LV) 400 mg/m2 over 30 minutes or according to local standard, followed by IV fluorouracil (5-FU) 2400 mg/m2 over 46 hours, every 2 weeks.
* Pembrolizumab (Keytruda®) 200 mg once every three weeks (given as a 30 minute IV infusion)
* Beginning on Day 10, BL-8040 twice a week and following the chemotherapy dosing (given by SC injections)
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
65.35 years
STANDARD_DEVIATION 13.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
17 participants
n=5 Participants
|
7 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=5 Participants
|
19 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change in response between screening, end of monotherapy (Day 5), end of cycle 2 (Day 28) and approximately every 63 days until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.Population: Best Response according to RECIST 1.1 Principal analysis for this endpoint used the mITT Analysis Set
Response is determined by assessment of target lesions identified in CT or MRI imaging. The ORR is assessed according to RECIST 1.1, defined as the sum of PRs (Partial Responses) and CRs (Complete Responses) determined according to best response RECIST 1.1 criteria. PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. CR is defined as disappearance of all target lesions.
Outcome measures
| Measure |
Cohort 1: BL-8040 + Pembrolizumab
n=30 Participants
Monotherapy: BL-8040 1.25 mg/kg subcutaneous (SC) injections daily on Days 1-5 of Week 1 of treatment.
Combination Therapy: Combination therapy period begins following monotherapy treatment and consists of:
* Pembrolizumab (Keytruda®) 200 mg once every three weeks (given as a 30 minute IV infusion)
* Beginning on Day 10, BL-8040 three times a week (given as SC injections) Principal analysis for this endpoint used the mITT Analysis Set N=30
|
Cohort 2: BL-8040 + Pembrolizumab + Chemotherapy
n=39 Participants
Monotherapy: BL-8040 1.25 mg/kg subcutaneous (SC) injections daily on Days 1-5 of Week 1 of treatment.
Combination Therapy: Combination therapy period begins following monotherapy treatment and consists of:
* Chemotherapy: IV Onivyde® 70 mg/m2 over 90 minutes, followed by IV leucovorin (LV) 400 mg/m2 over 30 minutes or according to local standard, followed by IV fluorouracil (5-FU) 2400 mg/m2 over 46 hours, every 2 weeks.
* Pembrolizumab (Keytruda®) 200 mg once every three weeks (given as a 30 minute IV infusion).
* Beginning on Day 10, BL-8040 twice a week and following the chemotherapy dosing (given as SC injections) Principal analysis for this endpoint used the mITT Analysis Set N=39
|
|---|---|---|
|
Objective Response Rate (ORR) Assessed by Imaging According to RECIST 1.1 Criteria
|
1 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Through study completion, an average of 2 years for cohort of the study, and follow-up until date of death up to 100 weeks.Population: Intention To Treat (ITT)
The length of time elapsed from monotherapy Day 1 to death
Outcome measures
| Measure |
Cohort 1: BL-8040 + Pembrolizumab
n=37 Participants
Monotherapy: BL-8040 1.25 mg/kg subcutaneous (SC) injections daily on Days 1-5 of Week 1 of treatment.
Combination Therapy: Combination therapy period begins following monotherapy treatment and consists of:
* Pembrolizumab (Keytruda®) 200 mg once every three weeks (given as a 30 minute IV infusion)
* Beginning on Day 10, BL-8040 three times a week (given as SC injections) Principal analysis for this endpoint used the mITT Analysis Set N=30
|
Cohort 2: BL-8040 + Pembrolizumab + Chemotherapy
n=43 Participants
Monotherapy: BL-8040 1.25 mg/kg subcutaneous (SC) injections daily on Days 1-5 of Week 1 of treatment.
Combination Therapy: Combination therapy period begins following monotherapy treatment and consists of:
* Chemotherapy: IV Onivyde® 70 mg/m2 over 90 minutes, followed by IV leucovorin (LV) 400 mg/m2 over 30 minutes or according to local standard, followed by IV fluorouracil (5-FU) 2400 mg/m2 over 46 hours, every 2 weeks.
* Pembrolizumab (Keytruda®) 200 mg once every three weeks (given as a 30 minute IV infusion).
* Beginning on Day 10, BL-8040 twice a week and following the chemotherapy dosing (given as SC injections) Principal analysis for this endpoint used the mITT Analysis Set N=39
|
|---|---|---|
|
Overall Survival
|
3.3 months
Interval 2.8 to 7.5
|
6.6 months
Interval 4.5 to 8.7
|
SECONDARY outcome
Timeframe: Through study completion, an average of 2 yearsPopulation: Intention to treat population
Progression-free Survival (PFS) by imaging (assessed according to RECIST 1.1). Progression is determined by assessment of target lesions identified in CT or MRI imaging. Progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Cohort 1: BL-8040 + Pembrolizumab
n=37 Participants
Monotherapy: BL-8040 1.25 mg/kg subcutaneous (SC) injections daily on Days 1-5 of Week 1 of treatment.
Combination Therapy: Combination therapy period begins following monotherapy treatment and consists of:
* Pembrolizumab (Keytruda®) 200 mg once every three weeks (given as a 30 minute IV infusion)
* Beginning on Day 10, BL-8040 three times a week (given as SC injections) Principal analysis for this endpoint used the mITT Analysis Set N=30
|
Cohort 2: BL-8040 + Pembrolizumab + Chemotherapy
n=43 Participants
Monotherapy: BL-8040 1.25 mg/kg subcutaneous (SC) injections daily on Days 1-5 of Week 1 of treatment.
Combination Therapy: Combination therapy period begins following monotherapy treatment and consists of:
* Chemotherapy: IV Onivyde® 70 mg/m2 over 90 minutes, followed by IV leucovorin (LV) 400 mg/m2 over 30 minutes or according to local standard, followed by IV fluorouracil (5-FU) 2400 mg/m2 over 46 hours, every 2 weeks.
* Pembrolizumab (Keytruda®) 200 mg once every three weeks (given as a 30 minute IV infusion).
* Beginning on Day 10, BL-8040 twice a week and following the chemotherapy dosing (given as SC injections) Principal analysis for this endpoint used the mITT Analysis Set N=39
|
|---|---|---|
|
Progression-free Survival (PFS) by Imaging (RECIST 1.1)
|
1.5 Months
Interval 1.5 to 1.8
|
3.8 Months
Interval 1.6 to 5.1
|
SECONDARY outcome
Timeframe: Through study completion, an average of 2 yearsPopulation: Modified Intention To Treat (mITT)
Sum of Partial Response (PR), Complete Response (CR) and Stable Disease (SD). PR is defined as an at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. CR is defined as disappearance of all target lesions. Progressive Disease (PD) is defined as an at least 20% increase in the sum of the longest diameter of target lesions. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
Cohort 1: BL-8040 + Pembrolizumab
n=30 Participants
Monotherapy: BL-8040 1.25 mg/kg subcutaneous (SC) injections daily on Days 1-5 of Week 1 of treatment.
Combination Therapy: Combination therapy period begins following monotherapy treatment and consists of:
* Pembrolizumab (Keytruda®) 200 mg once every three weeks (given as a 30 minute IV infusion)
* Beginning on Day 10, BL-8040 three times a week (given as SC injections) Principal analysis for this endpoint used the mITT Analysis Set N=30
|
Cohort 2: BL-8040 + Pembrolizumab + Chemotherapy
n=39 Participants
Monotherapy: BL-8040 1.25 mg/kg subcutaneous (SC) injections daily on Days 1-5 of Week 1 of treatment.
Combination Therapy: Combination therapy period begins following monotherapy treatment and consists of:
* Chemotherapy: IV Onivyde® 70 mg/m2 over 90 minutes, followed by IV leucovorin (LV) 400 mg/m2 over 30 minutes or according to local standard, followed by IV fluorouracil (5-FU) 2400 mg/m2 over 46 hours, every 2 weeks.
* Pembrolizumab (Keytruda®) 200 mg once every three weeks (given as a 30 minute IV infusion).
* Beginning on Day 10, BL-8040 twice a week and following the chemotherapy dosing (given as SC injections) Principal analysis for this endpoint used the mITT Analysis Set N=39
|
|---|---|---|
|
Disease Control (DC)
|
10 Participants
|
25 Participants
|
Adverse Events
Cohort 1: BL-8040 + Pembrolizumab
Serious events: 27 serious events
Other events: 37 other events
Deaths: 5 deaths
Cohort 2: BL-8040 + Pembrolizumab + Chemotherapy
Serious events: 27 serious events
Other events: 42 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Cohort 1: BL-8040 + Pembrolizumab
n=37 participants at risk
Monotherapy: BL-8040 1.25 mg/kg subcutaneous (SC) injections daily on Days 1-5 of Week 1 of treatment.
Combination Therapy: Combination therapy period begins following monotherapy treatment and consists of:
* Pembrolizumab (Keytruda®) 200 mg once every three weeks (given as a 30 minute IV infusion).
* Beginning on Day 10, BL-8040 three times a week (given as SC injections)
|
Cohort 2: BL-8040 + Pembrolizumab + Chemotherapy
n=43 participants at risk
Monotherapy: BL-8040 1.25 mg/kg subcutaneous (SC) injections daily on Days 1-5 of Week 1 of treatment.
Combination Therapy: Combination therapy period begins following monotherapy treatment and consists of:
* Chemotherapy: IV Onivyde® 70 mg/m2 over 90 minutes, followed by IV leucovorin (LV) 400 mg/m2 over 30 minutes or according to local standard, followed by IV fluorouracil (5-FU) 2400 mg/m2 over 46 hours, every 2 weeks.
* Pembrolizumab (Keytruda®) 200 mg once every three weeks (given as a 30 minute IV infusion).
* Beginning on Day 10, BL-8040 twice a week and following the chemotherapy dosing (given as SC injections)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.8%
4/37 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Duodenal obstruction
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Nausea
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
4.7%
2/43 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
14.0%
6/43 • Number of events 6 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Asthenia
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Fatigue
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
7.0%
3/43 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
General physical health deterioration
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Malaise
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Organ failure
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Hepatobiliary disorders
Cholangitis
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Pyrexia
|
5.4%
2/37 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Infections and infestations
Clostridium difficile colitis
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Infections and infestations
Herpes zoster
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Infections and infestations
Infection
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Infections and infestations
Pneumonia
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Infections and infestations
Sepsis
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Investigations
Blood bilirubin increased
|
10.8%
4/37 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Renal and urinary disorders
Renal failure
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Reproductive system and breast disorders
Genital pain
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Vascular disorders
Deep vein thrombosis
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
9.3%
4/43 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Gastric fistula
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
4.7%
2/43 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Infections and infestations
Liver abscess
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Infections and infestations
Abscess limb
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
4.7%
2/43 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour compression
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Nervous system disorders
Vocal cord paresis
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Product Issues
Device occlusion
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
4.7%
2/43 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
Other adverse events
| Measure |
Cohort 1: BL-8040 + Pembrolizumab
n=37 participants at risk
Monotherapy: BL-8040 1.25 mg/kg subcutaneous (SC) injections daily on Days 1-5 of Week 1 of treatment.
Combination Therapy: Combination therapy period begins following monotherapy treatment and consists of:
* Pembrolizumab (Keytruda®) 200 mg once every three weeks (given as a 30 minute IV infusion).
* Beginning on Day 10, BL-8040 three times a week (given as SC injections)
|
Cohort 2: BL-8040 + Pembrolizumab + Chemotherapy
n=43 participants at risk
Monotherapy: BL-8040 1.25 mg/kg subcutaneous (SC) injections daily on Days 1-5 of Week 1 of treatment.
Combination Therapy: Combination therapy period begins following monotherapy treatment and consists of:
* Chemotherapy: IV Onivyde® 70 mg/m2 over 90 minutes, followed by IV leucovorin (LV) 400 mg/m2 over 30 minutes or according to local standard, followed by IV fluorouracil (5-FU) 2400 mg/m2 over 46 hours, every 2 weeks.
* Pembrolizumab (Keytruda®) 200 mg once every three weeks (given as a 30 minute IV infusion).
* Beginning on Day 10, BL-8040 twice a week and following the chemotherapy dosing (given as SC injections)
|
|---|---|---|
|
General disorders
Pyrexia
|
21.6%
8/37 • Number of events 21 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
23.3%
10/43 • Number of events 16 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Infections and infestations
Pharyngitis
|
5.4%
2/37 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Infections and infestations
Skin infection
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Infections and infestations
Urinary tract infection
|
5.4%
2/37 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
7.0%
3/43 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Injury, poisoning and procedural complications
Contusion
|
10.8%
4/37 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Injury, poisoning and procedural complications
Fall
|
5.4%
2/37 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
8.1%
3/37 • Number of events 6 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Injury, poisoning and procedural complications
Skin injury
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Investigations
Alanine aminotransferase increased
|
8.1%
3/37 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
14.0%
6/43 • Number of events 9 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Investigations
Aspartate aminotransferase increased
|
10.8%
4/37 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
14.0%
6/43 • Number of events 10 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Investigations
Blood alkaline phosphatase increased
|
18.9%
7/37 • Number of events 12 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
11.6%
5/43 • Number of events 6 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Investigations
Blood bilirubin increased
|
18.9%
7/37 • Number of events 11 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
11.6%
5/43 • Number of events 5 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Investigations
Blood creatinine increased
|
5.4%
2/37 • Number of events 5 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
7.0%
3/43 • Number of events 7 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Investigations
Blood glucose increased
|
8.1%
3/37 • Number of events 7 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.1%
3/37 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
11.6%
5/43 • Number of events 6 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Investigations
Platelet count decreased
|
10.8%
4/37 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
4.7%
2/43 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Investigations
Weight decreased
|
13.5%
5/37 • Number of events 11 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
20.9%
9/43 • Number of events 20 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Investigations
White blood cell count increased
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
45.9%
17/37 • Number of events 22 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
41.9%
18/43 • Number of events 30 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Metabolism and nutrition disorders
Dehydration
|
16.2%
6/37 • Number of events 8 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
14.0%
6/43 • Number of events 11 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Blood and lymphatic system disorders
Anemia
|
18.9%
7/37 • Number of events 9 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
32.6%
14/43 • Number of events 42 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
4.7%
2/43 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.8%
4/37 • Number of events 8 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
11.6%
5/43 • Number of events 10 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Cardiac disorders
Palpitation
|
8.1%
3/37 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Cardiac disorders
Sinus tachycardia
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Cardiac disorders
Tachycardia
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
4.7%
2/43 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Endocrine disorders
Hyperthyroidism
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
4.7%
2/43 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Endocrine disorders
Hypothyroidism
|
10.8%
4/37 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Eye disorders
Visual impairment
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Eye disorders
Vitreous floaters
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.1%
3/37 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Abdominal distension
|
13.5%
5/37 • Number of events 5 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
7.0%
3/43 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Abdominal pain
|
37.8%
14/37 • Number of events 21 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
32.6%
14/43 • Number of events 22 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Ascites
|
13.5%
5/37 • Number of events 12 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
4.7%
2/43 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Constipation
|
27.0%
10/37 • Number of events 17 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
18.6%
8/43 • Number of events 13 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Diarrhoea
|
27.0%
10/37 • Number of events 15 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
51.2%
22/43 • Number of events 70 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Dyspepsia
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
9.3%
4/43 • Number of events 5 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Flatulence
|
8.1%
3/37 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
9.3%
4/43 • Number of events 5 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Nausea
|
35.1%
13/37 • Number of events 21 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
67.4%
29/43 • Number of events 71 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Stomatitis
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
7.0%
3/43 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Vomiting
|
35.1%
13/37 • Number of events 29 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
53.5%
23/43 • Number of events 72 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Asthenia
|
13.5%
5/37 • Number of events 7 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
37.2%
16/43 • Number of events 24 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Chills
|
16.2%
6/37 • Number of events 12 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
7.0%
3/43 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Fatigue
|
56.8%
21/37 • Number of events 33 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
48.8%
21/43 • Number of events 58 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Injection site bruising
|
13.5%
5/37 • Number of events 8 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Injection site discomfort
|
5.4%
2/37 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
4.7%
2/43 • Number of events 6 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Injection site erythema
|
29.7%
11/37 • Number of events 36 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
11.6%
5/43 • Number of events 7 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Injection site haemorrhage
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Injection site induration
|
5.4%
2/37 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
9.3%
4/43 • Number of events 5 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Injection site nodule
|
5.4%
2/37 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Injection site pain
|
59.5%
22/37 • Number of events 45 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
65.1%
28/43 • Number of events 63 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Injection site pruritus
|
35.1%
13/37 • Number of events 15 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
11.6%
5/43 • Number of events 8 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Injection site rash
|
10.8%
4/37 • Number of events 5 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Injection site reaction
|
21.6%
8/37 • Number of events 11 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
14.0%
6/43 • Number of events 8 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Injection site swelling
|
13.5%
5/37 • Number of events 7 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Injection site warmth
|
5.4%
2/37 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Oedema peripheral
|
18.9%
7/37 • Number of events 9 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
16.3%
7/43 • Number of events 10 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Pain
|
5.4%
2/37 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
7.0%
3/43 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Metabolism and nutrition disorders
Hyperglicaemia
|
5.4%
2/37 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
7.0%
3/43 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.2%
6/37 • Number of events 6 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
9.3%
4/43 • Number of events 12 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
20.9%
9/43 • Number of events 22 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.1%
3/37 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
14.0%
6/43 • Number of events 9 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.2%
6/37 • Number of events 13 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
11.6%
5/43 • Number of events 7 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
29.7%
11/37 • Number of events 14 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
14.0%
6/43 • Number of events 10 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.8%
4/37 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
4.7%
2/43 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.4%
2/37 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.2%
6/37 • Number of events 9 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
4.7%
2/43 • Number of events 5 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Nervous system disorders
Dizziness
|
10.8%
4/37 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
20.9%
9/43 • Number of events 11 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Nervous system disorders
Dysgeusia
|
8.1%
3/37 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
18.6%
8/43 • Number of events 11 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Nervous system disorders
Headache
|
8.1%
3/37 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
11.6%
5/43 • Number of events 8 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Nervous system disorders
Neuropathy peripheral
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Psychiatric disorders
Anxiety
|
8.1%
3/37 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
4.7%
2/43 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Psychiatric disorders
Depression
|
8.1%
3/37 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
9.3%
4/43 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.8%
4/37 • Number of events 5 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
7.0%
3/43 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
29.7%
11/37 • Number of events 15 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
11.6%
5/43 • Number of events 14 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
2.3%
1/43 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
13.5%
5/37 • Number of events 19 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
18.6%
8/43 • Number of events 11 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
10.8%
4/37 • Number of events 5 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
7.0%
3/43 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
51.4%
19/37 • Number of events 68 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
34.9%
15/43 • Number of events 44 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
32.4%
12/37 • Number of events 19 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
27.9%
12/43 • Number of events 25 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
5.4%
2/37 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
0.00%
0/43 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.1%
3/37 • Number of events 15 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
4.7%
2/43 • Number of events 9 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
24.3%
9/37 • Number of events 29 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
4.7%
2/43 • Number of events 11 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Vascular disorders
Flushing
|
37.8%
14/37 • Number of events 27 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
16.3%
7/43 • Number of events 29 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Vascular disorders
Hypertension
|
18.9%
7/37 • Number of events 30 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
4.7%
2/43 • Number of events 47 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Vascular disorders
Hypotension
|
13.5%
5/37 • Number of events 10 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
4.7%
2/43 • Number of events 2 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
11.6%
5/43 • Number of events 7 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Eye disorders
Vision blurred
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
7.0%
3/43 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
9.3%
4/43 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Gastrointestinal disorders
Dry mouth
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
7.0%
3/43 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Influenza like illness
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
9.3%
4/43 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Mucosal inflammation
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
14.0%
6/43 • Number of events 10 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
General disorders
Oedema
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
7.0%
3/43 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
14.0%
6/43 • Number of events 9 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
7.0%
3/43 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
9.3%
4/43 • Number of events 6 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Metabolism and nutrition disorders
Hypothyroidism
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
14.0%
6/43 • Number of events 6 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
7.0%
3/43 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
7.0%
3/43 • Number of events 3 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Nervous system disorders
Paraesthesia
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
9.3%
4/43 • Number of events 8 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Psychiatric disorders
Insomnia
|
2.7%
1/37 • Number of events 1 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
9.3%
4/43 • Number of events 4 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
16.3%
7/43 • Number of events 14 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/37 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
32.6%
14/43 • Number of events 20 • Study treatment duration, up to 2 years for each cohort. cohort 1 and cohort 2 were conducted sequentially, with cohort 2 initiated following completion of cohort 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The restrictions are as per the signed agreement with each PI and institution.
- Publication restrictions are in place
Restriction type: OTHER