AstraZeneca initiates Phase 3 CLARITY-Gastric 02 trial of AZD0901 combo in CLDN18.2+ gastric cancer

CAR-T Digest - August 2020

10 March 2026: AstraZeneca initiates Phase 3 CLARITY-Gastric 02 trial of AZD0901 combo in CLDN18.2+ gastric cancer

AstraZeneca has initiated the Phase 3 CLARITY-Gastric 02 trial evaluating Sonesitatug vedotin (AZD0901) in combination with capecitabine, with or without rilvegostomig, for the first-line treatment of Claudin 18.2-positive, HER2-negative advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma
The multi-center, randomized, controlled study has now dosed its first patient and aims to evaluate the efficacy and safety of the combination regimen in a population with limited targeted treatment options in the frontline setting
AZD0901 (CMG901) is being globally developed by AstraZeneca under an exclusive licensing agreement with Keymed Biosciences and its subsidiary KYM Biosciences, and the initiation of this Phase 3 trial has triggered a milestone payment of US$45 million from AstraZeneca to the partners
The asset has previously received regulatory support, including Breakthrough Therapy designation in China for Claudin 18.2-positive advanced gastric cancer and both Orphan Drug and Fast Track designations from the U.S. FDA for relapsed or refractory gastric cancer and gastroesophageal junction adenocarcinoma
Beyond the CLARITY-Gastric 02 study, AstraZeneca continues to advance Sonesitatug vedotin across multiple clinical trials targeting several solid tumors, including gastric, pancreatic, and biliary tract cancers, reflecting its broader development strategy in Claudin 18.2-expressing malignancies