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Sonesitatug vedotin + capecitabine is an investigational combination regimen consisting of sonesitatug vedotin (Sone-Ve, AZD0901), a Claudin 18.2 (CLDN18.2)-targeted antibody-drug conjugate (ADC), and capecitabine, an oral fluoropyrimidine chemotherapy prodrug of 5-fluorouracil. Sonesitatug vedotin comprises a humanized anti-CLDN18.2 monoclonal antibody conjugated to the cytotoxic microtubule inhibitor monomethyl auristatin E (MMAE) via a protease-cleavable linker. Capecitabine is converted enzymatically to 5-fluorouracil in vivo, where it inhibits thymidylate synthase to block DNA synthesis. This combination is being evaluated in the Phase III CLARITY-Gastric02 trial (NCT07431281) as a first-line treatment for patients with CLDN18.2-positive, HER2-negative advanced or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma, specifically in cohorts who are PD-L1 negative or ineligible for immune checkpoint inhibitors.
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