eligibility_summary
Eligibility: 18–75, ECOG 0–1, ≥3 mo survival, measurable disease, adequate organs, consent. Coh1: HER2+ adv gastric/GEJ, no prior systemic Rx (except adjuvant >6m). Coh2: adv solid tumors w/o options, HER2‑low. Coh3: adv gastric/GEJ or CRC, HER2‑low, mCRC RAS/BRAF WT, no prior systemic Rx (except adjuvant >6m). Exclude: recent therapy/surgery or immunosuppression/live vaccines, unresolved AEs, dMMR/MSI‑H, CNS mets, active HIV/HBV/HCV, major heart/lung/autoimmune disease, other cancers <5y, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II/III trial of IAH0968 with or without CAPEOX for HER2-expressing tumors, Phase III compares IAH0968+CAPEOX vs trastuzumab+CAPEOX in HER2-positive gastric/GEJ cancer. IAH0968: investigational antibody-based immunotherapy targeting HER2, intended to inhibit HER2 signaling on tumor cells and promote immune-mediated cytotoxicity (e.g., ADCC). CAPEOX: capecitabine (oral 5‑FU prodrug, antimetabolite inhibiting thymidylate synthase) plus oxaliplatin (platinum causing DNA crosslinks). Target cells/pathways: HER2/ERBB2 on tumor cells, DNA synthesis/repair (thymidylate synthase and platinum-induced damage), immune effector killing of HER2-expressing cells. Comparator: trastuzumab (anti‑HER2 mAb)+CAPEOX.