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New trial
Colorectal cancer

Phase 2 botensilimab Fc‑enhanced anti‑CTLA‑4 + balstilimab PD‑1 antibody in MSS colon cancer

Trial ID
NCT07595874 on ClinicalTrials.gov
Cancer type
Colorectal Cancer
Stage of research
Exploratory
Location
11 US locations (AZ, CA, GA, IL)
Published in
New in Oncology - June 4, 2026

City of Hope Medical Center is running this Phase 2 neoadjuvant study (NEST3) testing whether short-course dual checkpoint blockade—botensilimab (a next‑generation, Fc‑enhanced anti‑CTLA‑4 monoclonal antibody) plus balstilimab (an anti‑PD‑1 monoclonal antibody)—can induce meaningful pathologic tumor regression before standard colon resection in resectable stage IIB–IIIC, first-line MSS/pMMR colon cancer. Treatment is botensilimab IV on day 1 plus balstilimab IV on days 1, 15, 29, and 43, followed by surgery 5–16 weeks later, with imaging (CT/MRI) and blood/biospecimen collection to correlate immune effects with response. The scientific/commercial angle is bringing an immunotherapy backbone that has shown signals in “cold” MSS colorectal cancer into the curative-intent window, where even modest increases in deep response could translate into fewer recurrences. Today’s care for resectable stage II–III colon cancer is upfront surgery followed by risk-adapted adjuvant chemotherapy (commonly fluoropyrimidine + oxaliplatin), while immunotherapy is largely reserved for dMMR/MSI‑H disease rather than MSS/pMMR.

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