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After interim-analysis: No signals of clinical or immunological efficacy detected, and decision was made not to continue the trial.
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This phase 1/2 study will evaluate the safety, tolerance and dose of BM7PE treating patients with colorectal cancer who have progressed to standard cell therapy or cannot tolerate such therapy. The study starts as a phase 1 study with the aim of assessing the final recommended dose of BM7PE for this group of patients. Based on the results, the study will continue into a phase 2. The phase 2 study aim to examine overall survival ≥ 9.3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BM7PE Dose level 1 (2.5 µg/kg) | Experimental | 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 Dose level 2 (5 µg/kg) | Experimental | 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 Dose Level 3 (7.5 µg/kg) | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BM7PE | Drug | BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting Toxicity | Number of participants experiencing a dose-limiting toxicity event | Dose limiting toxicity event from time of study treatment and until 4 weeks after last dose of IMP, a maximum of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the BM7PE: Overall Survival | The Overall Survival will be measured as number of months from start study treatment to date of death of any cause | Up to 12 months from start study treatment |
| Efficacy of the BM7PE: Progression-free Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geir O Hjortland, MDPhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | Oslo | 0310 | Norway |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: 2,5 µg/kg |
| |||||||||||||
| Period 2: 5 µg/kg |
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| Period 3: 7,5 µg/kg |
| |||||||||||||
| Period 4: 10 µg/kg |
|
Baseline characteristics are described for each treatment group
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| ID | Title | Description |
|---|---|---|
| BG000 | BM7PE Treatment 2.5 μg/kg | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number of participants in each of the age categories |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Efficacy of the BM7PE: Overall Survival | The Overall Survival will be measured as number of months from start study treatment to date of death of any cause | Posted | Median | Standard Error | Months | Up to 12 months from start study treatment |
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aspartate aminotransferase increased - CTCAE grade 3 | Investigations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | Infections and infestations | Non-systematic Assessment | Fever 38-39 degrees Celsius |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Geir Olav Hjortland | Oslo University Hospital | +4790214796 | goo@ous-hf.no |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2023 | Jan 21, 2026 | Prot_SAP_000.pdf |
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Phase 1 study in colorectal cancer patients
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| BM7PE Dose level 4 (10 µg/kg) | Experimental | 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. |
|
| BM7PE Dose level 5 (15 µg/kg) | Experimental | Dose level 5: BM7PE immunotoxin (15 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 Dose level 6 (20 µg/kg) | Experimental | Dose level 6: BM7PE immunotoxin (20 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. |
|
The 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
| 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 months |
| Radiological Response to BM7PE | Radiological 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). | 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 months |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | BM7PE Treatment 5 μg/kg | 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. |
| BG002 | BM7PE Treatment 7.5 μg/kg | 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. |
| BG003 | BM7PE Treatment 10 μg/kg | 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. |
| BG004 | Total | Total of all reporting groups |
Number of participants in each of the specified age categories are listed
| Count of Participants |
| Participants |
| No |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| ECOG Performance status | "ECOG 0 = Fully active and can perform daily activities. ECOG 1 = Restricted activity, light work only. Higher ECOG scores mean worse status | Count of Participants | Participants | No |
|
| BM7PE Treatment 5 μg/kg |
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. |
| OG002 | BM7PE Treatment 7.5 μg/kg | 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. |
| OG003 | BM7PE Treatment 10 μg/kg | 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. |
|
|
| Secondary | Efficacy of the BM7PE: Progression-free Survival | The 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 | Posted | Median | Standard Error | Months | 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 months |
|
|
|
| Secondary | Radiological Response to BM7PE | Radiological 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). | Posted | Count of Participants | Participants | 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 months |
|
|
|
| Primary | Dose-limiting Toxicity | Number of participants experiencing a dose-limiting toxicity event | Posted | Count of Participants | Participants | Dose limiting toxicity event from time of study treatment and until 4 weeks after last dose of IMP, a maximum of 12 months |
|
|
|
| 3 |
| 3 |
| 0 |
| 3 |
| 2 |
| 3 |
| EG001 | 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. | 3 | 3 | 0 | 3 | 3 | 3 |
| EG002 | 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. | 2 | 3 | 0 | 3 | 1 | 3 |
| EG003 | 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. | 5 | 5 | 2 | 5 | 5 | 5 |
| Alanine aminotransferase increased - CTCAE grade 3 | Gastrointestinal disorders | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Alanine amonitransferase increased | Investigations | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | Systematic Assessment |
|
| Lung infection | Infections and infestations | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| ECOG perfomance status 1 |
|
| Partial Response (PR) |
|
| Stable disease (SD) |
|
| Progressive Disease (PD) |
|