eligibility_summary
Inclusion: histologically confirmed gastric/GEJ adenocarcinoma, advanced/recurrent/metastatic disease confirmed within 28 days, suitable for chemo plus PD-1, not a candidate for anti-HER2, at least one measurable lesion by RECIST 1.1 within 28 days, CLDN18.2 positive. Exclusion: active CNS mets/meningitis, significant gastric bleeding, uncontrolled third-space fluid, prior anti-CLDN18.2, suspected GE access obstruction.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III, first-line trial in CLDN18.2-positive unresectable/metastatic gastric/GEJ adenocarcinoma testing: 1) ASKB589: a monoclonal antibody targeting Claudin18.2 on tumor cells, promoting immune-mediated cytotoxicity (ADCC/CDC) against CLDN18.2-expressing gastric/GEJ cancer cells. 2) Tislelizumab: anti–PD-1 immune checkpoint inhibitor (IgG4) that blocks PD-1/PD-L1/PD-L2, restoring T-cell activation and antitumor immunity. 3) CAPOX chemotherapy: Oxaliplatin (platinum DNA crosslinker, can induce immunogenic cell death) and Capecitabine (oral 5-FU prodrug, thymidylate synthase inhibition → impaired DNA synthesis). Targets/pathways: Claudin18.2 on malignant epithelial cells, PD-1/PD-L1 immune checkpoint on T cells, DNA synthesis/repair in rapidly dividing tumor cells, Fc-mediated NK cell ADCC.