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.
More in colorectal cancer
-
New trial · Oct 15, 2026 · NCT07750158
Phase 3 STELLAR-316 tests zanzalintinib with or without pembrolizumab for ctDNA-positive, scan-negative colorectal cancer -
New trial · Oct 15, 2026 · NCT07842965
Phase 1/1b CHAMP adds CCR5 blockade with leronlimab to surgery, hepatic arterial floxuridine, and systemic therapy for colorectal liver metastases -
New trial · Oct 15, 2026 · NCT07551596
Phase 2 COMBAT tests botensilimab plus balstilimab for ctDNA-positive molecular residual disease in MSS colorectal cancer -
New trial · Oct 8, 2026 · NCT07811193
Phase 2 VVD-133214 WRN helicase covalent inhibitor + pembrolizumab (PD-1 antibody) in MSI/dMMR CRC -
New trial · Oct 8, 2026 · NCT07808151
Phase 2 porustobart CTLA-4 antibody + pembrolizumab PD-1 antibody in resectable MSS colon cancer
