drugset / Trial / NCT05576896
Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab in the Treatment of Metastatic BRAF-mutated Colorectal Cancer Refractory
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase II, open label, single-arm trial study of adding hydroxychloroquine to encorafenib and cetuximab in patients with metastatic BRAF V600E colon cancer with progression on at least 1 prior line of therapy. We hypothesize that autophagy is a major mechanism of resistance to BRAF inhibition in stage IV BRAF V600E colorectal cancer, and that the addition of hydroxychloroquine to standard encorafenib and cetuximab therapy will help overcome this resistance.
Timeline
- Start
- 2022-10-10
- Primary completion
- 2025-10-24
- Completion
- 2026-04-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydroxychloroquine | Small molecule | 400 mg | — |
| Background | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Background | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Background | Encorafenib | Small molecule | 300 mg | — |
| Background | Panitumumab | Monoclonal antibody | 6 mg/kg | Intravenous |