eligibility_summary
Adults ≥18 with MSS metastatic/unresectable CRC limited to lung/lymph/locoregional sites (no liver/bone/brain, ≤3 with peritoneal carcinomatosis). Measurable disease, ECOG 0–1, no prior systemic CRC therapy (adjuvant/neoadjuvant per PI), biopsy willing, adequate organs, contraception, >3‑mo survival. Exclude prior ICI, pregnancy, significant autoimmune/pancreatitis/pneumonitis, immunosuppression, recent live vaccine/infection/major surgery, nonhealing wounds, severe cardiac, transplant, obstruction/refractory ascites, +TB.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06268015 tests stepwise therapy in MSS metastatic/unresectable colorectal cancer: first botensilimab + balstilimab, at progression add mFOLFOX6 plus bevacizumab or panitumumab. Mechanisms/types: Botensilimab—Fc-enhanced anti-CTLA-4 monoclonal antibody, boosts T-cell priming and can deplete intratumoral Tregs via ADCC. Balstilimab—anti-PD-1 monoclonal antibody, reverses T-cell exhaustion. Oxaliplatin—platinum cytotoxic causing DNA crosslinks. 5-fluorouracil—antimetabolite inhibiting thymidylate synthase. Leucovorin—folinic acid that stabilizes FdUMP–TS complex to potentiate 5-FU. Bevacizumab—anti-VEGF-A monoclonal antibody, anti-angiogenic. Panitumumab—anti-EGFR monoclonal antibody, blocks RAS/RAF/MEK/ERK signaling. Targets: effector T cells and regulatory T cells (CTLA-4/PD-1), tumor DNA synthesis/replication, tumor vasculature (VEGF), and EGFR-driven tumor cell signaling.