eligibility_summary
Untreated, unresectable locally advanced/metastatic gastric or GEJ adenocarcinoma, submit FFPE/fresh tumor tissue, CLDN18.2+ and PD‑L1 CPS, measurable/evaluable disease, chemo‑eligible. Exclude prior systemic therapy, recent RT, anti‑CLDN18.2, recent TCM/vaccines, GI obstruction/bleeding, squamous/undiff or HER2+ tumors, active cancers, CNS mets, immunodeficiency/immunosuppression/autoimmunity, pneumonitis, ≥G2 neuropathy, active infection, recent surgery, CV/QTc, prior transplant.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3, randomized, double-blind trial in HER2–, CLDN18.2+ advanced/metastatic gastric/GEJ adenocarcinoma testing: 1) TST001: recombinant humanized monoclonal antibody against Claudin 18.2 (targeted antibody). MOA: binds CLDN18.2 on tumor cells, promoting immune-mediated killing (ADCC/CDC) and direct tumor cell targeting. 2) Nivolumab: anti–PD-1 IgG4 monoclonal antibody (immune checkpoint inhibitor) that reactivates exhausted T cells by blocking PD-1 signaling. 3) Chemotherapy backbone: CapOx or mFOLFOX6—oxaliplatin (platinum DNA cross-linker), 5-FU/capecitabine (antimetabolites inhibiting thymidylate synthase), and leucovorin (enhances 5-FU). Targets/pathways: CLDN18.2-expressing tumor cells, PD-1/PD-L1 immune checkpoint on T cells, DNA synthesis/repair pathways via thymidylate synthase inhibition and platinum-induced DNA damage.