eligibility_summary
Include: 18–75, ECOG 0–1, HER2+ (IHC3+ or 2+/ISH+), BTC unresectable/recurrent/metastatic with measurable disease post standard therapy, contraception/neg pregnancy test. Exclude: recent other cancer/therapy/surgery, unresolved >G1 tox, major bleed/thrombosis/high bleeding risk, active hepatitis/TB/ILD/pneumonia, serious comorbidity, high‑dose antiplatelets, uncontrolled effusions/ascites/biliary obstruction, uncontrolled CNS mets, allergy, prior anti‑HER2 (phase 2), immunosuppression, recent trial.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06431490 (Phase 1/2, single-arm) in HER2-positive locally advanced/metastatic biliary tract cancer. Intervention: TQB2102 for injection, a HER2 dual‑antibody–drug conjugate (ADC), given IV every 3 weeks. Mechanism of action: TQB2102 uses a bispecific anti‑HER2 antibody that binds two HER2 epitopes to enhance HER2 engagement and internalization. After binding HER2 on tumor cells, the ADC is internalized and releases a cytotoxic payload intracellularly to kill cancer cells, the antibody component can also inhibit HER2 signaling and may trigger Fc‑mediated immune effector functions (e.g., ADCC). Cells/pathways targeted: HER2 (ERBB2) overexpressing or amplified/mutant biliary tract tumor cells, HER2 receptor tyrosine kinase signaling and downstream PI3K/AKT and MAPK pathways via receptor blockade and targeted payload delivery. The study evaluates efficacy, safety, and immunogenicity.