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A Phase I/II Study With BM7PE Immunotoxin in Colorectal Cancer Patients
Sponsor: Oslo University Hospital
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
Conditions
Interventions
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