eligibility_summary
Eligible: ≥19, adv/metastatic or unresectable gastric/GEJ adenocarcinoma, CLDN18.2+ (≥75% cells, mod-strong IHC), HER2–, 1L zolbetuximab, ECOG 0-1, labs: Hb ≥8 g/dL (≥9 post-tx), ANC ≥1.0, Plt ≥75 (x10^9/L), bili ≤1.5xULN (≤3x w/ liver mets), AST/ALT ≤2.5x (≤5x w/ mets), CrCl ≥30. Exclude: prior zolbetuximab trials, hypersensitivity, prior systemic chemo for adv disease (neo/adjuvant ≥6 mo ago ok), recent immunosuppression, gastric outlet obstruction, GI bleeding/ulcers, other unsuitability.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06767449 is a real-world, multicenter observational cohort of zolbetuximab plus physician’s-choice chemotherapy in CLDN18.2-positive, HER2‑negative advanced gastric/GEJ adenocarcinoma. Zolbetuximab (IMAB362) is an IgG1 monoclonal antibody that binds the tight-junction protein Claudin 18.2 on tumor cell membranes, triggering immune-mediated killing via FcγR-driven ADCC and complement-dependent cytotoxicity (with potential ADCP). The chemo backbone is standard cytotoxic therapy (non-targeted cell‑killing of proliferating cells). Targets/pathways: CLDN18.2-expressing gastric cancer cells (tight-junction/claudin pathway) and immune effector pathways (NK cell Fcγ engagement, complement cascade). Biomarker assessments include tumor PD‑L1, MMR status, CLDN18.2 by IHC, and blood-based ctDNA/scRNAseq/immune profiling to correlate with response.