Trials / Unknown
UnknownNCT04550897
A Phase I/II Study With BM7PE Immunotoxin in Colorectal Cancer Patients
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.
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Oslo University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 dose 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BM7PE | BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml. |
Timeline
- Start date
- 2020-08-31
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
- First posted
- 2020-09-16
- Last updated
- 2023-03-22
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT04550897. Inclusion in this directory is not an endorsement.