eligibility_summary
Eligibility: Adults with unresectable LA/metastatic gastric/GEJ adenocarcinoma, HER2 IHC 2+/3+, measurable disease, no prior systemic therapy or relapse >6 mo after (neo)adjuvant, ECOG 0–1, adequate organ function incl LVEF≥50/NYHA<III, contraception. Exclude: serious CV/CVA disease, ILD/pneumonitis, immune deficiency/HIV/transplant, serious infection/TB, CNS mets, recent major surgery, GI bleed/perf risk, recent live vaccine/trials, allergy, investigator deems unsafe.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Single-arm Phase II first-line therapy for HER2-overexpressing advanced gastric/GEJ cancer testing Disitamab Vedotin (RC48) plus Cadonilimab (AK104). Drugs/mechanisms: • Disitamab Vedotin (ADC, anti-HER2 mAb linked to MMAE). Binds HER2 on tumor cells, is internalized, and releases MMAE to inhibit microtubules, causing mitotic arrest/apoptosis, may also mediate ADCC. • Cadonilimab (tetravalent bispecific immune-checkpoint antibody). Simultaneously blocks PD‑1 and CTLA‑4, reversing T-cell exhaustion and enhancing priming/effector function. Cells/pathways targeted: • HER2-overexpressing tumor cells, HER2 signaling, microtubule/mitotic machinery. • PD‑1+ and CTLA‑4+ T cells, PD‑1/PD‑L1 and CTLA‑4/CD80/86 pathways in the tumor microenvironment. Potential synergy: ADC-induced tumor antigen release plus dual-checkpoint activation.