eligibility_summary
Adults ≥18 with advanced/metastatic solid tumors, ECOG ≤2, life >12 wks, measurable disease, and adequate organ function. Phase I: any tumor, CLDN18.2 testing. Phase II: CLDN18.2+ only (central IHC). Exclude severe mAb/topoisomerase-ADC allergy, serious illness, uncontrolled CNS mets, active infection, recent anticancer therapy/surgery, live vaccines or strong CYP3A4/2D6 use, pregnancy, Phase II also excludes prior CLDN18.2 ADC/CAR-T and multiple recent primaries. Contraception required.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: XNW27011, a first-in-human Claudin 18.2–targeted antibody-drug conjugate (biologic ADC). Mechanism: the monoclonal antibody binds CLDN18.2 on tumor cell membranes (a tight-junction claudin), is internalized, and releases a cytotoxic topoisomerase I inhibitor payload, leading to Topo‑I inhibition, DNA damage, and tumor cell death, administered Q3W. Targets: CLDN18.2-expressing epithelial tumor cells. Indications under study include gastric/gastroesophageal junction adenocarcinoma, pancreatic adenocarcinoma, ovarian cancer, and other CLDN18.2-positive tumors (esophageal adenocarcinoma, NSCLC, colorectal, biliary tract). Pathways/cells: CLDN18.2 tight-junction pathway on cancer cells and downstream DNA replication/repair via Topo‑I inhibition. Phase I dose escalation, Phase II expansion in CLDN18.2+ tumors.