drugset / Trial / NCT05985109
KN 046 Plus Regorafenib in MSS Metastatic Colorectal Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The study is an interventional Phase II clinical trial aiming to optimize immunotherapy strategies for microsatellite-stable colorectal cancer. We will include three types of metastatic colorectal cancer patients: those without liver metastasis, or carrying BRAF V600E mutation, or unable to tolerate chemotherapy as their initial or second-line treatment. The participants will receive a combination treatment of regorafenib and KN046 which is a PD-L1/CTLA-4 bispecific antibody. Treatment efficacy and safety profile would be evaluated in this study.
Timeline
- Start
- 2023-10-26
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ERFONRILIMAB | Monoclonal antibody | — | — |
| Subject | Regorafenib | Small molecule | — | — |