eligibility_summary
Inclusion: age 18–75, consent/compliance, locally advanced HER2+ gastric or GEJ adenocarcinoma, ECOG 0–1, LVEF ≥50%, adequate organ function: bilirubin ≤ULN (≤1.5×ULN if Gilbert/liver mets), AST/ALT ≤1.5×ULN (≤3× if liver mets), creatinine ≤1.5×ULN and CrCl ≥60 mL/min, Hb ≥90 g/L, ANC ≥1.5×10^9/L, platelets ≥100×10^9/L, PT/INR/aPTT ≤1.5×ULN, life expectancy >3 mo. Exclusion: other active cancer ≤5 y, transplant, MI/arrhythmia ≤6 mo, NYHA III–IV or LVEF <50%, HIV, active TB, interstitial lung disease, prior PD‑1/PD‑L1/CTLA‑4, other high‑risk conditions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, sequential, multicenter study in HER2+ resectable gastric/GEJ adenocarcinoma. Interventions: (1) KN026 + KN046, if not meeting statistical hypothesis, (2) KN026 + KN046 + XELOX (oxaliplatin + capecitabine). Drug types/mechanisms: KN026 is a bispecific anti-HER2 monoclonal antibody that binds two non-overlapping HER2 epitopes to produce dual HER2 signaling blockade on tumor cells (blocking HER2-driven pathways such as MAPK and PI3K/AKT). KN046 is a bispecific checkpoint inhibitor antibody targeting PD-L1 and CTLA-4 to relieve immune suppression and enhance T-cell activation. XELOX: oxaliplatin (platinum DNA crosslinker) plus capecitabine (5-FU prodrug, thymidylate synthase inhibitor). Target cells/pathways: HER2-overexpressing tumor cells, PD-1/PD-L1 axis and CTLA-4 on T cells/APCs, DNA synthesis/repair in proliferating tumor cells.