eligibility_summary
Eligibility: Adults (≥18) with locally advanced/metastatic solid tumors with KRAS G12D, ECOG 0–1. For select groups, must have progressed on, be intolerant/ineligible to, or decline standard therapy, or have no standard options, cohort-specific rules apply. Exclude: prior KRAS G12D inhibitor, another invasive cancer within 1 yr, history of organ transplant (incl. allogeneic stem cell transplant), significant uncontrolled illness, ECG abnormalities, inadequate organ function. Other criteria may apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, open-label study in adults with advanced/metastatic solid tumors harboring KRAS G12D, testing INCB161734 alone and in combinations. INCB161734: selective small-molecule KRAS G12D inhibitor that blocks RAS signaling (downstream MAPK/ERK and PI3K-AKT) in tumor cells. Combinations: cetuximab (anti-EGFR monoclonal antibody, inhibits EGFR→RAS signaling), retifanlimab (anti-PD-1 monoclonal antibody, reactivates T cells), GEMNabP (gemcitabine antimetabolite inhibiting DNA synthesis + nab-paclitaxel microtubule stabilizer), mFOLFIRINOX/FOLFOX/FOLFIRI (5-FU/leucovorin thymidylate synthase inhibition with oxaliplatin DNA crosslinking and/or irinotecan topoisomerase-I inhibition), INCA33890 (investigational, mechanism not specified). Targets/pathways: KRAS G12D–mutant cancer cells, EGFR–RAS–MAPK and PI3K–AKT signaling, PD-1 on T cells, DNA replication/mitosis.