eligibility_summary
Adults ≥18 with unresectable/metastatic gastric, GEJ, or distal esophageal adenocarcinoma, CLDN18.2-positive, progressed after ≥1 prior line incl fluoropyrimidine+platinum, measurable/evaluable disease, ECOG 0–1, life ≥12 wks, adequate organs, weight ≥35 kg, contraception/consent required. Exclude HER2+, significant gastric bleeding/ulcers, CNS disease/metastases, corneal disease, persistent ≥G2 toxicities, prior MMAE-ADC/CLDN18.2 tx, recent thromboembolism, or other unsafe conditions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III randomized trial in 2L+ advanced/metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2. Interventions: AZD0901 (sonesitatug vedotin) — an anti‑CLDN18.2 antibody‑drug conjugate (ADC) with an MMAE payload. Mechanism: binds CLDN18.2 on tumor cells, is internalized, releases MMAE to disrupt microtubules causing mitotic arrest/apoptosis, may also mediate Fc‑dependent ADCC. Comparators (investigator’s choice): ramucirumab (anti‑VEGFR2 mAb) ± paclitaxel, paclitaxel or docetaxel (taxane microtubule stabilizers), irinotecan (topoisomerase I inhibitor), TAS‑102 (trifluridine/tipiracil antimetabolite), apatinib (VEGFR2 TKI). Targets/pathways: CLDN18.2‑positive gastric/GEJ tumor cells, microtubule machinery, VEGF/VEGFR2 angiogenesis, DNA replication/synthesis (Topo I, nucleoside analog). Patient selection via Ventana CLDN18.2 IVD.