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TERMINATED
NCT04550897
PHASE1/PHASE2

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

Sponsor: Oslo University Hospital

View on ClinicalTrials.gov

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.

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

14

Start Date

2020-08-31

Completion Date

2025-05-06

Last Updated

2026-05-13

Healthy Volunteers

No

Interventions

DRUG

BM7PE

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

Locations (1)

Oslo University Hospital

Oslo, Oslo, Norway