eligibility_summary
Includes adults 18–75, ECOG 0–1, ≥12‑wk survival, unresectable or recurrent/metastatic biliary cancer, post‑chemo failure/intolerance, ≥1 measurable lesion (RECIST 1.1), adequate organ function, if HBV+, DNA <500 IU/mL, contraception. Excludes anticancer tx or major surgery/trauma ≤4 wks, CNS mets, pancreatitis or Child‑Pugh C, serious heart disease ≤6 mo, uncontrolled effusions, severe infection ≤2 wks, bleeding/thrombosis, immune defects, severe comorbids, stroke/PE/DVT ≤6 mo.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: SHR-A1811, a HER2-directed antibody–drug conjugate (ADC). Type: targeted biologic plus linked cytotoxic payload. Mechanism of action: the anti-HER2 monoclonal antibody binds HER2 (ERBB2) on tumor cells, is internalized, and releases an intracellular cytotoxic payload, leading to tumor cell death, also attenuates HER2-driven signaling and may exert a bystander effect on neighboring HER2-low cells. Cells/pathways targeted: HER2-expressing or amplified biliary tract cancer cells, the HER2/ERBB2 receptor and downstream proliferative/survival pathways (PI3K/AKT and MAPK). Study context: single-arm Phase II in BTC after failure of 1–2 prior systemic therapies.