ArticleESMO gastrointestinal oncology2026
Randomized phase II trial of zolbetuximab as second-line treatment in patients with claudin 18.2-positive advanced gastric/GEJ cancer with previous zolbetuximab exposure: ZELDA.
Article in ESMO gastrointestinal oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Zolbetuximab, an anti-claudin 18.2 (CLDN18.2) monoclonal antibody, combined with fluoropyrimidine- and platinum-based chemotherapy, is established as first-line standard of care for patients with CLDN18.2-positive, human epidermal growth factor receptor 2-negative advanced gastric or gastroesophageal junction (GEJ) cancer, based on the phase III SPOTLIGHT and GLOW trials. However, evidence regarding the efficacy and safety of continuing zolbetuximab beyond disease progression remains lacking. Given reports that CLDN18.2 expression is maintained after chemotherapy and the absence of clearly established resistance pathways, continued CLDN18.2-targeted therapy in the second-line setting warrants investigation. Aim: To investigate whether the addition of zolbetuximab to second-line nab-paclitaxel plus ramucirumab improves overall survival (OS) in patients with CLDN18.2-positive advanced gastric or GEJ adenocarcinoma who have progressed with first-line zolbetuximab-based therapy. Trial design: ZELDA (jRCTs071250038) is a multicenter, open-label, randomized phase II (rP2) trial conducted by the West Japan Oncology Group and Kyushu Study Group of Clinical Cancer in Japan. A safety lead-in part (
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