eligibility_summary
Adults 18–74 with HER2+ (IHC3+ or IHC2+/FISH+) gastric/GEJ adenocarcinoma that’s unresectable/recurrent/metastatic, measurable, ECOG 0–1, ≥12‑wk survival, failed ≥1 line (±anti‑HER2 mAb), adequate marrow/renal/hepatic function, contraception required. Exclude: allergy, LVEF<50%, prior anti‑HER2 ADC, recent immunotherapy/trial or surgery, uncontrolled CNS mets/epilepsy, serious systemic/other recent cancers, major cardiac disease/uncontrolled HTN, long‑term steroids, pregnancy/lactation, uncontrolled effusions/infection, unresolved ≥G2 AEs, concurrent study.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I/II, single-arm study testing Disitamab Vedotin (RC48) plus trastuzumab in previously treated HER2‑positive gastric/GEJ adenocarcinoma. Disitamab Vedotin is a HER2‑targeted antibody–drug conjugate (ADC) that delivers the microtubule inhibitor MMAE via a cleavable linker, after HER2 binding and internalization, MMAE disrupts tubulin, causing G2/M arrest and apoptosis, with potential bystander effect. Trastuzumab is a humanized anti‑HER2 IgG1 monoclonal antibody that inhibits HER2 signaling/dimerization and mediates ADCC via Fcγ receptor–bearing immune cells. Targets/pathways: HER2‑overexpressing tumor cells, downstream HER2–MAPK/PI3K‑AKT signaling, microtubules, immune effector ADCC. Strategy aims to saturate HER2 binding sites and improve tumor penetration of HER2‑directed therapy.