eligibility_summary
Eligible: adults 18–70 with confirmed unresectable/metastatic gastric or GEJ adenocarcinoma, HER2 IHC 1+, after ≥2nd‑line therapy with progression, ≥1 RECIST lesion, ECOG 0–1, life ≥12 wks, adequate marrow/liver/renal/cardiac function, contraception. Exclude: brain/leptomeningeal mets, bleeding risk/recent transfusion, recent other malignancy, recent chemo/IO/RT/TCM, major surgery or live vaccines, prior T‑DM1, unresolved AEs, thromboembolism, uncontrolled disease/infections (TB/HIV/HBV/HCV), uncontrolled effusions, hypersensitivity, pregnancy/poor compliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-arm phase I trial in advanced HER2-low (IHC 1+) gastric/GEJ cancer testing: 1) Disitamab vedotin (RC48): an anti-HER2 antibody–drug conjugate (ADC) delivering MMAE, a microtubule inhibitor. Mechanism: binds HER2 (ERBB2) on tumor cells, internalizes, releases MMAE to disrupt tubulin and induce apoptosis, may also drive ADCC and bystander killing. 2) Toripalimab: an anti–PD-1 IgG4 monoclonal antibody (immune checkpoint inhibitor). Mechanism: blocks PD-1 to reinvigorate cytotoxic T-cell responses. Key targets/pathways: HER2 on gastric cancer cells, microtubule dynamics via MMAE, PD-1/PD-L1 immune checkpoint on T cells, potential NK-cell engagement via Fc.