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Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy

StatusActive, Not Recruiting
PhasePhase 1/2
Started2023-05-11
View on ClinicalTrials.gov ↗
This phase I/II trial tests how well botensilimab, balstilimab, and regorafenib works in treating patients with microsatellite stable colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who have progressed on prior chemotherapy. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Regorafenib binds to and inhibits growth factor receptors, which may inhibit the growth of new blood vessels that tumors need to grow. Giving botensilimab, balstilimab, and regorafenib in combination may work better in treating patients with metastatic colorectal cancer than giving these drugs alone.

Amendment history 2 changes detected by DataLookout

2026-09-02
critical
Primary completion pushed: 2025-05-10 → 2026-04-08
2026-09-02
minor
Completion pushed: 2026-08-25 → 2026-12-01
Trial Details
NCT Number NCT05672316
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Advanced Colorectal Adenocarcinoma, Advanced Microsatellite Stable Colorectal Carcinoma, Metastatic Colorectal Adenocarcinoma, Metastatic Microsatellite Stable Colorectal Carcinoma, Stage III Colorectal Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8
Enrollment 28 participants
Start Date 2023-05-11
Primary Completion 2026-04-08 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-01