eligibility_summary
Adults ≥18. Ib: HER2+ advanced solid tumors after standard Tx failure, GC frontline, measurable lesion, ECOG 0–1, adequate labs incl LVEF ≥50%, survival ≥3 mo, consent/contraception. IIa: untreated HER2+ LA/metastatic BTC, same requirements. Exclude: hypersensitivity, recent surgery/radiation/live vaccine/transfusion, unresolved toxicities, recent HER2 Rx or prior GC (Ib), CNS mets, transplant, severe cardiac, active HBV/HCV/HIV/TB, severe pulmonary/biliary infection, PI discretion.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drugs/interventions: 1) IAH0968 + gemcitabine + cisplatin (GC) vs placebo + GC (Phase II). IAH0968: investigational HER2-targeted monoclonal antibody (IV, q3wk). Likely blocks HER2/ERBB2 signaling and triggers Fc-mediated cytotoxicity (ADCC/ADCP). Gemcitabine: antimetabolite nucleoside analog inhibiting ribonucleotide reductase and DNA synthesis (S-phase). Cisplatin: platinum DNA crosslinker causing DNA damage and apoptosis. Targets (cells/pathways): • HER2-overexpressing/mutant tumor cells, HER2/ERBB2 receptor tyrosine kinase and downstream PI3K/AKT and RAS/MAPK pathways. • FcγR-expressing immune effector cells (e.g., NK cells, macrophages) engaged for ADCC/ADCP. • Tumor cell DNA replication/repair machinery via GC (DNA synthesis inhibition and crosslink-induced apoptosis). Intended for HER2-positive unresectable/metastatic tumors, with a focus on biliary tract cancer.