drugset / Trial / NCT04550897
A Phase I/II Study With BM7PE Immunotoxin in Colorectal Cancer Patients
Non-randomizedSingle-groupOpen-labelDiagnostic
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.
Timeline
- Start
- 2020-08-31
- Primary completion
- 2024-06-30
- Completion
- 2025-05-06
Outcome
Outcome not reported
Stopped: “After interim-analysis: No signals of clinical or immunological efficacy detected, and decision was made not to continue the trial.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BM7PE | Protein / enzyme biologic | 2.5 ug/kg | Intravenous |
| Subject | BM7PE | Protein / enzyme biologic | 5 ug/kg | Intravenous |
| Subject | BM7PE | Protein / enzyme biologic | 7.5 ug/kg | Intravenous |
| Subject | BM7PE | Protein / enzyme biologic | 10 ug/kg | Intravenous |
| Subject | BM7PE | Protein / enzyme biologic | 15 ug/kg | Intravenous |
| Subject | BM7PE | Protein / enzyme biologic | 20 ug/kg | Intravenous |