eligibility_summary
Adults (≥18) CLDN18.2+, measurable disease, ECOG 0–1, adequate organs. S1: adv/met gastric or GEJ adeno, ≤2 prior lines. S2: adv/met PDAC, tissue available, no prior metastatic tx, adjuvant ok if >6 mo. S3: adv/met biliary adeno, ≤2 lines. Exclusions: active GI bleed/ascites, ILD, CNS mets, ≥G2 neuropathy, prior MMAE‑ADC or CLDN18.2(except mAb), S1: HER2+ unless ineligible, QTc prolongers, S2: DPD def, strong UGT1A1/CYP3A4 mods, UGT1A128 homozygous, S3: unresolved biliary obstruction.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06219941 tests AZD0901 (CMG901), an antibody–drug conjugate (biologic) targeting Claudin 18.2 (CLDN18.2) in advanced CLDN18.2+ solid tumors (gastric/GEJ, pancreatic ductal, biliary tract). Mechanism: AZD0901 binds CLDN18.2 on tumor cells, is internalized, and releases a cytotoxic payload to kill CLDN18.2-expressing cells. Combination partners in PDAC and their mechanisms: 5-fluorouracil (antimetabolite, thymidylate synthase inhibition and RNA/DNA effects), leucovorin or l-leucovorin (folinic acid, enhances 5-FU–TS binding), irinotecan or nanoliposomal irinotecan (topoisomerase I inhibitors), and gemcitabine (deoxycytidine analog, inhibits DNA synthesis). Targets/pathways: CLDN18.2 on epithelial tumor cells (tight junction claudin), thymidylate synthase pathway, topoisomerase I–mediated DNA relaxation, and DNA replication/repair.