eligibility_summary
Adults ≥18 with advanced/metastatic HER2‑altered tumors (Phase 1a: any solid, Phase 1b/2: GC/BC/BTC/CRC/gynecologic), adequate marrow/organ function, LVEF ≥50%, and contraception. Exclude: recent antitumor therapy or CYP3A4 inhibitors, unresolved >G1 toxicities, symptomatic CNS mets, lung/cardiac disease, active infections incl. HIV/HBV/HCV/COVID/TB/syphilis, uncontrolled HTN, recent arterial events, GI obstruction/IBD, or inadequate washout (surgery/RT/chemo/immuno).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: First‑in‑human Phase 1/2, single‑arm study of IBI354 in advanced/unresectable or metastatic solid tumors with HER2 alterations. Drug/intervention: IBI354, a biological antibody‑drug conjugate (ADC): recombinant anti‑HER2 monoclonal antibody linked to a camptothecin‑derived payload (topoisomerase I inhibitor). Mechanism: IBI354 binds HER2 on tumor cells, is internalized, and releases the camptothecin derivative to inhibit Topo I, causing DNA damage and tumor cell death, it may also suppress HER2 signaling and engage Fc‑mediated effector functions. Cells/pathways targeted: HER2/ERBB2‑expressing tumor cells (e.g., gastric, breast, biliary, colorectal, gynecologic cancers), pathways impacted include HER2 signaling and DNA replication/repair via Topo I inhibition.