eligibility_summary
Adults ≥18 with unresectable HER2+ mCRC (RAS/BRAF WT, no prior systemic tx or >6 mo post-adjuvant) or HER2+ biliary tract cancer (tx-naive, >6 mo post-adjuvant RT), LVEF ≥50%, adequate organ/thyroid function, survival ≥3 mo, CAPOX eligible, contraception. Exclude: untreated CNS mets, ampullary ca, prior metastatic tx/trial, recent steroids or live vaccine, ILD, autoimmune disease, HBV/HCV/HIV/TB or active infection, CVD/QTc, bleeding, transplant, severe drug allergy, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 first-line study in HER2-positive metastatic colorectal or biliary tract cancer. Interventions: KN026—HER2-targeted bispecific monoclonal antibody binding two HER2 epitopes to inhibit HER2 signaling and may enhance ADCC, KN046—bispecific immune checkpoint antibody blocking PD-L1/PD-1 and CTLA-4/CD80/86 to boost T-cell activation, XELOX—capecitabine (oral 5-FU prodrug inhibiting thymidylate synthase) plus oxaliplatin (platinum DNA crosslinker). Arms: A (mCRC: KN026+XELOX), B (mCRC: KN026+KN046+XELOX), C (BTC: KN026+KN046+XELOX). Targets/pathways: HER2 on tumor cells (ERBB2→MAPK/PI3K), PD-L1 on tumor/immune cells, PD-1 and CTLA-4 on T cells, CD80/86 on APCs, chemotherapy targets rapidly dividing tumor cells via DNA damage and impaired nucleotide synthesis.