Trial Outcomes & Findings for A Phase I/II Study With BM7PE Immunotoxin in Colorectal Cancer Patients (NCT NCT04550897)
NCT ID: NCT04550897
Last Updated: 2026-05-13
Results Overview
Number of participants experiencing a dose-limiting toxicity event
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Dose limiting toxicity event from time of study treatment and until 4 weeks after last dose of IMP, a maximum of 12 months
Results posted on
2026-05-13
Participant Flow
Participant milestones
| Measure |
BM7PE 2.5 µg/kg
Dose level 1: BM7PE immunotoxin (2,5 µg/kg) was supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml and administered as a 20-minute i.v. infusion. The treatment was repeated after 2 weeks (day 15). The patients were treated as in-patients to stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease - at least an in-hospital stay minimum of 3 days. A 4 week follow-up for adverse events after last dose of BM7PE was performed.
|
BM7PE 5 µg/kg
Dose Level 2: BM7PE immunotoxin (5 µg/kg) was supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml and administered as a 20-minute i.v. infusion. The treatment was repeated after 2 weeks (day 15). The patients were treated as in-patients to stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease - at least an in-hospital stay minimum of 3 days. A 4 week follow-up for adverse events after last dose of BM7PE was performed.
|
BM7PE 7.5 µg/kg
Dose Level 3: BM7PE immunotoxin (7,5 µg/kg) was supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml and administered as a 20-minute i.v. infusion. The treatment was repeated after 2 weeks (day 15). The patients were treated as in-patients to stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease - at least an in-hospital stay minimum of 3 days. A 4 week follow-up for adverse events after last dose of BM7PE was performed.
|
BM7PE 10 µg/kg
Dose Level 4: BM7PE immunotoxin (10 µg/kg) was supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml and administered as a 20-minute i.v. infusion. The treatment was repeated after 2 weeks (day 15). The patients were treated as in-patients to stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease - at least an in-hospital stay minimum of 3 days. A 4 week follow-up for adverse events after last dose of BM7PE was performed.
|
|---|---|---|---|---|
|
Period 1: 2,5 µg/kg
STARTED
|
3
|
0
|
0
|
0
|
|
Period 1: 2,5 µg/kg
COMPLETED
|
3
|
0
|
0
|
0
|
|
Period 1: 2,5 µg/kg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2: 5 µg/kg
STARTED
|
0
|
3
|
0
|
0
|
|
Period 2: 5 µg/kg
COMPLETED
|
0
|
3
|
0
|
0
|
|
Period 2: 5 µg/kg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3: 7,5 µg/kg
STARTED
|
0
|
0
|
3
|
0
|
|
Period 3: 7,5 µg/kg
COMPLETED
|
0
|
0
|
3
|
0
|
|
Period 3: 7,5 µg/kg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 4: 10 µg/kg
STARTED
|
0
|
0
|
0
|
5
|
|
Period 4: 10 µg/kg
COMPLETED
|
0
|
0
|
0
|
5
|
|
Period 4: 10 µg/kg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Number of participants in each of the specified age categories are listed
Baseline characteristics by cohort
| Measure |
BM7PE Treatment 2.5 μg/kg
n=3 Participants
Dose level 1:The BM7PE treatment will be administered as a 20-minute i.v. infusion. The treatment is repeated after 2 weeks (day 15). The patients will be treated as in-patients and will stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease. For at least a minimum of 3 days.
The dose administered to the patient will be 2.5, 5.0, 7.5, 10.0, 15.0 and 20.0 μg/kg body weight.
BM7PE: BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
|
BM7PE Treatment 5 μg/kg
n=3 Participants
Dose level 2:The BM7PE treatment will be administered as a 20-minute i.v. infusion. The treatment is repeated after 2 weeks (day 15). The patients will be treated as in-patients and will stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease. For at least a minimum of 3 days.
The dose administered to the patient will be 2.5, 5.0, 7.5, 10.0, 15.0 and 20.0 μg/kg body weight.
BM7PE: BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
|
BM7PE Treatment 7.5 μg/kg
n=3 Participants
Dose level 3:The BM7PE treatment will be administered as a 20-minute i.v. infusion. The treatment is repeated after 2 weeks (day 15). The patients will be treated as in-patients and will stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease. For at least a minimum of 3 days.
The dose administered to the patient will be 2.5, 5.0, 7.5, 10.0, 15.0 and 20.0 μg/kg body weight.
BM7PE: BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
|
BM7PE Treatment 10 μg/kg
n=5 Participants
Dose level 4:The BM7PE treatment will be administered as a 20-minute i.v. infusion. The treatment is repeated after 2 weeks (day 15). The patients will be treated as in-patients and will stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease. For at least a minimum of 3 days.
The dose administered to the patient will be 2.5, 5.0, 7.5, 10.0, 15.0 and 20.0 μg/kg body weight.
BM7PE: BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants • Number of participants in each of the specified age categories are listed
|
0 Participants
n=3 Participants • Number of participants in each of the specified age categories are listed
|
0 Participants
n=3 Participants • Number of participants in each of the specified age categories are listed
|
0 Participants
n=5 Participants • Number of participants in each of the specified age categories are listed
|
0 Participants
n=14 Participants • Number of participants in each of the specified age categories are listed
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=3 Participants • Number of participants in each of the specified age categories are listed
|
1 Participants
n=3 Participants • Number of participants in each of the specified age categories are listed
|
1 Participants
n=3 Participants • Number of participants in each of the specified age categories are listed
|
3 Participants
n=5 Participants • Number of participants in each of the specified age categories are listed
|
6 Participants
n=14 Participants • Number of participants in each of the specified age categories are listed
|
|
Age, Categorical
>=65 years
|
2 Participants
n=3 Participants • Number of participants in each of the specified age categories are listed
|
2 Participants
n=3 Participants • Number of participants in each of the specified age categories are listed
|
2 Participants
n=3 Participants • Number of participants in each of the specified age categories are listed
|
2 Participants
n=5 Participants • Number of participants in each of the specified age categories are listed
|
8 Participants
n=14 Participants • Number of participants in each of the specified age categories are listed
|
|
Age, Continuous
|
65 years
n=3 Participants
|
63.3 years
n=3 Participants
|
65.7 years
n=3 Participants
|
59.6 years
n=5 Participants
|
62.9 years
n=14 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=14 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
ECOG Performance status
ECOG perfomance status 0
|
3 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=14 Participants
|
|
ECOG Performance status
ECOG perfomance status 1
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Dose limiting toxicity event from time of study treatment and until 4 weeks after last dose of IMP, a maximum of 12 monthsNumber of participants experiencing a dose-limiting toxicity event
Outcome measures
| Measure |
BM7PE Treatment 7.5 μg/kg
n=3 Participants
Dose level 3: The BM7PE treatment will be administered as a 20-minute i.v. infusion. The treatment is repeated after 2 weeks (day 15). The patients will be treated as in-patients and will stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease. For at least a minimum of 3 days.
The dose administered to the patient will be 2.5, 5.0, 7.5, 10.0, 15.0 and 20.0 μg/kg body weight.
BM7PE: BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
|
BM7PE Treatment 10 μg/kg
n=5 Participants
Dose level 4: The BM7PE treatment will be administered as a 20-minute i.v. infusion. The treatment is repeated after 2 weeks (day 15). The patients will be treated as in-patients and will stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease. For at least a minimum of 3 days.
The dose administered to the patient will be 2.5, 5.0, 7.5, 10.0, 15.0 and 20.0 μg/kg body weight.
BM7PE: BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
|
BM7PE Treatment 2.5 μg/kg
n=3 Participants
Dose level 1: The BM7PE treatment will be administered as a 20-minute i.v. infusion. The treatment is repeated after 2 weeks (day 15). The patients will be treated as in-patients and will stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease. For at least a minimum of 3 days.
The dose administered to the patient will be 2.5, 5.0, 7.5, 10.0, 15.0 and 20.0 μg/kg body weight.
BM7PE: BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
|
BM7PE Treatment 5 μg/kg
n=3 Participants
Dose level 2: The BM7PE treatment will be administered as a 20-minute i.v. infusion. The treatment is repeated after 2 weeks (day 15). The patients will be treated as in-patients and will stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease. For at least a minimum of 3 days.
The dose administered to the patient will be 2.5, 5.0, 7.5, 10.0, 15.0 and 20.0 μg/kg body weight.
BM7PE: BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
|
|---|---|---|---|---|
|
Dose-limiting Toxicity
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months from start study treatmentThe Overall Survival will be measured as number of months from start study treatment to date of death of any cause
Outcome measures
| Measure |
BM7PE Treatment 7.5 μg/kg
n=3 Participants
Dose level 3: The BM7PE treatment will be administered as a 20-minute i.v. infusion. The treatment is repeated after 2 weeks (day 15). The patients will be treated as in-patients and will stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease. For at least a minimum of 3 days.
The dose administered to the patient will be 2.5, 5.0, 7.5, 10.0, 15.0 and 20.0 μg/kg body weight.
BM7PE: BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
|
BM7PE Treatment 10 μg/kg
n=5 Participants
Dose level 4: The BM7PE treatment will be administered as a 20-minute i.v. infusion. The treatment is repeated after 2 weeks (day 15). The patients will be treated as in-patients and will stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease. For at least a minimum of 3 days.
The dose administered to the patient will be 2.5, 5.0, 7.5, 10.0, 15.0 and 20.0 μg/kg body weight.
BM7PE: BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
|
BM7PE Treatment 2.5 μg/kg
n=3 Participants
Dose level 1: The BM7PE treatment will be administered as a 20-minute i.v. infusion. The treatment is repeated after 2 weeks (day 15). The patients will be treated as in-patients and will stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease. For at least a minimum of 3 days.
The dose administered to the patient will be 2.5, 5.0, 7.5, 10.0, 15.0 and 20.0 μg/kg body weight.
BM7PE: BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
|
BM7PE Treatment 5 μg/kg
n=3 Participants
Dose level 2: The BM7PE treatment will be administered as a 20-minute i.v. infusion. The treatment is repeated after 2 weeks (day 15). The patients will be treated as in-patients and will stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease. For at least a minimum of 3 days.
The dose administered to the patient will be 2.5, 5.0, 7.5, 10.0, 15.0 and 20.0 μg/kg body weight.
BM7PE: BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
|
|---|---|---|---|---|
|
Efficacy of the BM7PE: Overall Survival
|
6.7 Months
Standard Error 2.8
|
5 Months
Standard Error 2.6
|
2.2 Months
Standard Error 0.4
|
11.5 Months
Standard Error 8.4
|
SECONDARY outcome
Timeframe: Time (months) from date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 monthsThe Progression-free Survival will be measured as number of months from start study treatment to date of disease progression (RECISTv1.1) or death of any cause
Outcome measures
| Measure |
BM7PE Treatment 7.5 μg/kg
n=3 Participants
Dose level 3: The BM7PE treatment will be administered as a 20-minute i.v. infusion. The treatment is repeated after 2 weeks (day 15). The patients will be treated as in-patients and will stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease. For at least a minimum of 3 days.
The dose administered to the patient will be 2.5, 5.0, 7.5, 10.0, 15.0 and 20.0 μg/kg body weight.
BM7PE: BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
|
BM7PE Treatment 10 μg/kg
n=5 Participants
Dose level 4: The BM7PE treatment will be administered as a 20-minute i.v. infusion. The treatment is repeated after 2 weeks (day 15). The patients will be treated as in-patients and will stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease. For at least a minimum of 3 days.
The dose administered to the patient will be 2.5, 5.0, 7.5, 10.0, 15.0 and 20.0 μg/kg body weight.
BM7PE: BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
|
BM7PE Treatment 2.5 μg/kg
n=3 Participants
Dose level 1: The BM7PE treatment will be administered as a 20-minute i.v. infusion. The treatment is repeated after 2 weeks (day 15). The patients will be treated as in-patients and will stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease. For at least a minimum of 3 days.
The dose administered to the patient will be 2.5, 5.0, 7.5, 10.0, 15.0 and 20.0 μg/kg body weight.
BM7PE: BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
|
BM7PE Treatment 5 μg/kg
n=3 Participants
Dose level 2: The BM7PE treatment will be administered as a 20-minute i.v. infusion. The treatment is repeated after 2 weeks (day 15). The patients will be treated as in-patients and will stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease. For at least a minimum of 3 days.
The dose administered to the patient will be 2.5, 5.0, 7.5, 10.0, 15.0 and 20.0 μg/kg body weight.
BM7PE: BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
|
|---|---|---|---|---|
|
Efficacy of the BM7PE: Progression-free Survival
|
1.2 Months
Standard Error 0
|
1.4 Months
Standard Error 0.73
|
1.47 Months
Standard Error 0.57
|
1.87 Months
Standard Error 0.57
|
SECONDARY outcome
Timeframe: From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 monthsRadiological Response Rate (assesed using RECIST v1.1) i.e. the number (and percentage) of participants in each of the response categories complete response (CR), partial response (PR), Stable disease (SD) and Progressive disease (PD).
Outcome measures
| Measure |
BM7PE Treatment 7.5 μg/kg
n=3 Participants
Dose level 3: The BM7PE treatment will be administered as a 20-minute i.v. infusion. The treatment is repeated after 2 weeks (day 15). The patients will be treated as in-patients and will stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease. For at least a minimum of 3 days.
The dose administered to the patient will be 2.5, 5.0, 7.5, 10.0, 15.0 and 20.0 μg/kg body weight.
BM7PE: BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
|
BM7PE Treatment 10 μg/kg
n=5 Participants
Dose level 4: The BM7PE treatment will be administered as a 20-minute i.v. infusion. The treatment is repeated after 2 weeks (day 15). The patients will be treated as in-patients and will stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease. For at least a minimum of 3 days.
The dose administered to the patient will be 2.5, 5.0, 7.5, 10.0, 15.0 and 20.0 μg/kg body weight.
BM7PE: BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
|
BM7PE Treatment 2.5 μg/kg
n=3 Participants
Dose level 1: The BM7PE treatment will be administered as a 20-minute i.v. infusion. The treatment is repeated after 2 weeks (day 15). The patients will be treated as in-patients and will stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease. For at least a minimum of 3 days.
The dose administered to the patient will be 2.5, 5.0, 7.5, 10.0, 15.0 and 20.0 μg/kg body weight.
BM7PE: BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
|
BM7PE Treatment 5 μg/kg
n=3 Participants
Dose level 2: The BM7PE treatment will be administered as a 20-minute i.v. infusion. The treatment is repeated after 2 weeks (day 15). The patients will be treated as in-patients and will stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease. For at least a minimum of 3 days.
The dose administered to the patient will be 2.5, 5.0, 7.5, 10.0, 15.0 and 20.0 μg/kg body weight.
BM7PE: BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
|
|---|---|---|---|---|
|
Radiological Response to BM7PE
Complete Response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Radiological Response to BM7PE
Partial Response (PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Radiological Response to BM7PE
Stable disease (SD)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Radiological Response to BM7PE
Progressive Disease (PD)
|
3 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
Adverse Events
BM7PE 2.5 µg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 3 deaths
BM7PE 5 µg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
BM7PE 7.5 µg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 2 deaths
BM7PE 10 µg/kg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
BM7PE 2.5 µg/kg
n=3 participants at risk
Dose level 1: BM7PE immunotoxin (2,5 µg/kg) was supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml and administered as a 20-minute i.v. infusion. The treatment was repeated after 2 weeks (day 15). The patients were treated as in-patients to stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease - at least an in-hospital stay minimum of 3 days. A 4 week follow-up for adverse events after last dose of BM7PE was performed.
|
BM7PE 5 µg/kg
n=3 participants at risk
Dose Level 2: BM7PE immunotoxin (5 µg/kg) was supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml and administered as a 20-minute i.v. infusion. The treatment was repeated after 2 weeks (day 15). The patients were treated as in-patients to stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease - at least an in-hospital stay minimum of 3 days. A 4 week follow-up for adverse events after last dose of BM7PE was performed.
|
BM7PE 7.5 µg/kg
n=3 participants at risk
Dose Level 3: BM7PE immunotoxin (7,5 µg/kg) was supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml and administered as a 20-minute i.v. infusion. The treatment was repeated after 2 weeks (day 15). The patients were treated as in-patients to stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease - at least an in-hospital stay minimum of 3 days. A 4 week follow-up for adverse events after last dose of BM7PE was performed.
|
BM7PE 10 µg/kg
n=5 participants at risk
Dose Level 4: BM7PE immunotoxin (10 µg/kg) was supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml and administered as a 20-minute i.v. infusion. The treatment was repeated after 2 weeks (day 15). The patients were treated as in-patients to stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease - at least an in-hospital stay minimum of 3 days. A 4 week follow-up for adverse events after last dose of BM7PE was performed.
|
|---|---|---|---|---|
|
Investigations
Aspartate aminotransferase increased - CTCAE grade 3
|
0.00%
0/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
0.00%
0/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
0.00%
0/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
20.0%
1/5 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
|
Gastrointestinal disorders
Alanine aminotransferase increased - CTCAE grade 3
|
0.00%
0/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
0.00%
0/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
0.00%
0/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
20.0%
1/5 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
Other adverse events
| Measure |
BM7PE 2.5 µg/kg
n=3 participants at risk
Dose level 1: BM7PE immunotoxin (2,5 µg/kg) was supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml and administered as a 20-minute i.v. infusion. The treatment was repeated after 2 weeks (day 15). The patients were treated as in-patients to stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease - at least an in-hospital stay minimum of 3 days. A 4 week follow-up for adverse events after last dose of BM7PE was performed.
|
BM7PE 5 µg/kg
n=3 participants at risk
Dose Level 2: BM7PE immunotoxin (5 µg/kg) was supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml and administered as a 20-minute i.v. infusion. The treatment was repeated after 2 weeks (day 15). The patients were treated as in-patients to stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease - at least an in-hospital stay minimum of 3 days. A 4 week follow-up for adverse events after last dose of BM7PE was performed.
|
BM7PE 7.5 µg/kg
n=3 participants at risk
Dose Level 3: BM7PE immunotoxin (7,5 µg/kg) was supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml and administered as a 20-minute i.v. infusion. The treatment was repeated after 2 weeks (day 15). The patients were treated as in-patients to stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease - at least an in-hospital stay minimum of 3 days. A 4 week follow-up for adverse events after last dose of BM7PE was performed.
|
BM7PE 10 µg/kg
n=5 participants at risk
Dose Level 4: BM7PE immunotoxin (10 µg/kg) was supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml and administered as a 20-minute i.v. infusion. The treatment was repeated after 2 weeks (day 15). The patients were treated as in-patients to stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease - at least an in-hospital stay minimum of 3 days. A 4 week follow-up for adverse events after last dose of BM7PE was performed.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
0.00%
0/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
0.00%
0/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
40.0%
2/5 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
33.3%
1/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
0.00%
0/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
0.00%
0/5 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
|
Infections and infestations
Fever
|
33.3%
1/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
0.00%
0/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
0.00%
0/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
0.00%
0/5 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
2/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
66.7%
2/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
0.00%
0/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
80.0%
4/5 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
|
Investigations
Alanine amonitransferase increased
|
33.3%
1/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
66.7%
2/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
0.00%
0/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
40.0%
2/5 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
0.00%
0/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
33.3%
1/3 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
0.00%
0/5 • From start study treatment and up to 4 weeks after last dose, a maximum of 12 months.
All events were graded according to CTCAE version 5.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place