Colorectal Cancer MetastaticPhase 1/2BM7PENCT04550897
A Phase I/II Study With BM7PE Immunotoxin in Colorectal Cancer Patients
A Phase 1/2 study testing BM7PE in people with Colorectal Cancer Metastatic, run by Oslo University Hospital at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- BM7PE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNorway
- Study dates
- 31 Aug 2020to 6 May 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically verified adenocarcinoma of colon or rectum
- Ambulatory with an ECOG performance status 0-1
- At least 18 years of age
- Progressive disease on or last line of standard chemotherapy or intolerance to further chemotherapy
- Laboratory values as the following: ANC, Platelets, Hb, Creatinine, Bilirubin, ASAT, ALAT, Albumin levels, INR
- Signed informed consent and expected cooperation of the patients for the treatment, and follow-up must be obtained and documented according to ICH GCP, and national/local regulations
Who cannot join
- History of prior metastatic disease the last 3 years
- History of CNS or bone metastases
- Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia
- Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment
- Alcohol or drug abuse
- Any reason why, in the opinion of the investigator, the patient should not participate
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- Has a known history of Human Immunodeficiency Virus (HIV)
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected)
- Is pregnant or breastfeeding, or expecting to conceive or father children within the project duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1/2 Study With BM7PE Immunotoxin in Colorectal Cancer Patients With Metastatic Disease Who Are Refractory to or With Intolerance to Last Line of Standard Chemotherapy.
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.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- BM7PE
- Keywords
- Intolerance last line standard chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BM7PEDrug
BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: BM7PE |
| 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. Receives: Drug: BM7PE |
| 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. Receives: Drug: BM7PE |
| 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. Receives: Drug: BM7PE |
| 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. Receives: Drug: BM7PE |
| 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. Receives: Drug: BM7PE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicity
Number of participants experiencing a dose-limiting toxicity event
Measured: Dose limiting toxicity event from time of study treatment and until 4 weeks after last dose of IMP, a maximum of 12 months
Secondary outcomes (3)
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
Measured: Up to 12 months from start study treatment
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
Measured: 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).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start31 Aug 2020
- Primary completion30 Jun 2024
- Study completion6 May 2025
Why it stopped: After interim-analysis: No signals of clinical or immunological efficacy detected, and decision was made not to continue the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Phase 1 study in colorectal cancer patients
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geir Olav Hjortland, Oslo University Hospital
- Investigators
- Geir O Hjortland, MDPhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550897
- Sponsor's protocol ID
- BM7PE
- Acronym
- BM7PE
- Status last verified
- May 2026
- First submitted
- 31 Aug 2020
- Last updated
- 13 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study With BM7PE Immunotoxin in Colorectal Cancer Patients With Metastatic Disease Who Are Refractory to or With Intolerance to Last Line of Standard Chemotherapy.
- ClinicalTrials.gov ID
- NCT04550897
- Acronym / sponsor ID
- BM7PE / BM7PE
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- Intolerance last line standard chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After interim-analysis: No signals of clinical or immunological efficacy detected, and decision was made not to continue the trial.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 6 May 2025 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Posted 13 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Phase 1 study in colorectal cancer patients
| Arm | Type | Receives |
|---|---|---|
| BM7PE Dose level 1 (2.5 µg/kg) | Experimental | Drug: BM7PEDose 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 | Drug: BM7PEDose 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 | Drug: BM7PEDose 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 Dose level 4 (10 µg/kg) | Experimental | Drug: BM7PEDose 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 | Drug: BM7PEDose 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 | Drug: BM7PEDose 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically verified adenocarcinoma of colon or rectum
- Ambulatory with an ECOG performance status 0-1
- At least 18 years of age
- Progressive disease on or last line of standard chemotherapy or intolerance to further chemotherapy
- Laboratory values as the following: ANC, Platelets, Hb, Creatinine, Bilirubin, ASAT, ALAT, Albumin levels, INR
Key exclusion criteria (9 listed)
- History of prior metastatic disease the last 3 years
- History of CNS or bone metastases
- Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia
- Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment
- Alcohol or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BM7PEBM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml. | Drug | BM7PE Dose Level 3 (7.5 µg/kg), BM7PE Dose level 1 (2.5 µg/kg), BM7PE Dose level 2 (5 µg/kg), BM7PE Dose level 4 (10 µg/kg), BM7PE Dose level 5 (15 µg/kg), BM7PE Dose level 6 (20 µg/kg) |
Primary outcome
Dose-limiting Toxicity
Time frame: Dose limiting toxicity event from time of study treatment and until 4 weeks after last dose of IMP, a maximum of 12 months
Number of participants experiencing a dose-limiting toxicity event
3 secondary outcomes
Efficacy of the BM7PE: Overall Survival
Time frame: Up to 12 months from start study treatment
Efficacy of the BM7PE: Progression-free Survival
Time frame: 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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geir O Hjortland, MDPhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BM7PE in people with Colorectal Cancer Metastatic, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting Toxicity (time frame: Dose limiting toxicity event from time of study treatment and until 4 weeks after last dose of IMP, a maximum of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.