A Phase I/II Study With BM7PE Immunotoxin in Colorectal Cancer Patients

NCT04550897 | Terminated Phase 1 Results

• 1 other identifier: BM7PE
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Intolerance last line standard chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Efficacy of the BM7PE: Overall Survival

  Up to 12 months from start study treatment

• Efficacy of the BM7PE: Progression-free Survival

  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

  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

Study Arms (6)

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.

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.

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.

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.

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.

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.

Drug: BM7PE

Interventions

BM7PE DRUG

BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Oslo, 0310, Norway

Location

Results Point of Contact

• Title: Dr. Geir Olav Hjortland
• Organization: Oslo University Hospital

goo@ous-hf.no

+4790214796

Study Officials

• Geir O Hjortland, MDPhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Model Details: Phase 1 study in colorectal cancer patients

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 16, 2020
• Study Start: August 31, 2020
• Primary Completion: June 30, 2024
• Study Completion: May 6, 2025
• Last Updated: May 13, 2026
• Results First Posted: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)