Drug intelligence / Profile preview

sonesitatug vedotin + capecitabine

Development stage
Phase 3
Lead developer
AstraZeneca
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous, Oral
01

Overview

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.

Other names
AZD0901 + capecitabineCM-G901 + capecitabineCMG901 + capecitabineSone-Ve + capecitabinesonesitatug vedotin and capecitabine
02

Targets

Claudin 18.2TS (Thymidylate synthase)

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