eligibility_summary
Adults 18–75, ECOG 0–1, HER2+ (IHC3+ or 2+/ISH+) unresectable advanced/metastatic GEA, PD‑L1 result/tissue, no prior systemic therapy for advanced disease (relapse ≥6 mo post‑adj allowed), measurable, adequate organs, contraception. Exclude: other cancer, >G1 toxicity, recent surgery/therapy/vaccine/trial drug, ILD/pneumonitis, recent thrombosis, CNS/bone‑spinal complications, bleeding, autoimmune disease/immunosuppression, hypersensitivity, psych illness/substance abuse, uncontrolled illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, HER2-positive gastroesophageal adenocarcinoma. Interventions: 1) TQB2102 for injection: a HER2-targeted antibody–drug conjugate (ADC). It is biparatopic, binding two non-overlapping HER2 extracellular epitopes (ECD2 and ECD4) to enhance receptor internalization and downregulate surface HER2, providing dual HER2 signaling blockade (trastuzumab- and pertuzumab-like) while delivering a cytotoxic payload. 2) Benmelstobart: anti–PD-L1 monoclonal antibody (immune checkpoint inhibitor). 3) Penpulimab: anti–PD-1 monoclonal antibody. 4) Chemotherapy: oral capecitabine (antimetabolite). Targets/pathways: tumor cell HER2 receptor and downstream HER2 signaling, PD-1/PD-L1 axis on T cells/tumor microenvironment, DNA synthesis in proliferating tumor cells (capecitabine/ADC payload).