eligibility_summary
Adults 18–75 with HER2-expressing, locally advanced unresectable or metastatic gastric/GEJ adenocarcinoma, ECOG 0–1, life expectancy ≥3 mo, adequate marrow/organ function. Phase Ib: failed/intolerant of prior therapy or naive, Phase II: untreated. Exclude effusions requiring treatment, major surgery <4 wks, autoimmune disease, interstitial pneumonia, severe infection <4 wks, active TB <1 yr, serious cardio/cerebrovascular disease, GI perforation/fistula <6 mo.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase Ib/II trial in advanced/metastatic HER2-expressing gastric/GEJ adenocarcinoma tests combinations of: • SHR-A1811: HER2-directed antibody–drug conjugate (ADC) that binds HER2 on tumor cells and delivers an internalized cytotoxic payload. • SHR-1701: bifunctional fusion protein combining an anti–PD-L1 antibody with a TGF-β receptor II “trap,” blocking PD-1/PD-L1 signaling and neutralizing TGF-β–mediated immunosuppression. • SHR-1316: anti–PD-L1 monoclonal antibody checkpoint inhibitor. • Chemotherapy: capecitabine (oral prodrug of 5-FU, antimetabolite inhibiting thymidylate synthase), 5-FU (antimetabolite, TS inhibitor), and oxaliplatin (platinum DNA cross-linker). Targeted cells/pathways: HER2+ tumor cells (HER2 RTK), immune evasion via PD-L1 on tumor/immune cells (T-cell reactivation), TGF-β-driven suppressive stroma/TME, and DNA synthesis/damage pathways in proliferating cancer cells.