CLARITY-Gastric 02
Research type
Research Study
Full title
A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug vedotin in Combination with Capecitabine with or without Rilvegostomig in First-line Claudin18.2-positive, HER2-negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)
IRAS ID
1012992
Contact name
Juliet Wou
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
Researchers are looking for a better way to treat advanced and metastatic stomach and oesophagus cancer. Knowing which proteins are present in a person’s cancer can help doctors select the best treatment. When tumours have a lot of cells that have a particular protein, they are called positive for that protein. In this trial, researchers will study gastroesophageal cancers that are Claudin (CLDN)18.2-positive and human epidermal growth factor receptor 2 (HER2)-negative.
The trial drug sonesitatug vedotin is designed to find tumour cells that have CLDN18.2 on them and kill them, delivering targeted chemotherapy, while rilvegostomig is an immunotherapy designed to help the immune system kill tumour cells. Researchers think that sonesitatug vedotin and standard chemotherapy (capecitabine) with or without rilvegostomig can help treat adults with gastroesophageal cancers that are CLDN18.2 positive. They want to know how well these treatment combinations work and how safe they are compared to standard treatment.
This is a Phase 3, randomised, open-label, trial with two cohorts. Participants in Cohort 1 will have cancers that also show higher levels of another protein called PD-L1, which means that the cancer is more likely to respond to immunotherapy. Participants in Cohort 2 will have cancers with low levels of PD-L1 or they are not able to receive immunotherapy for another reason. Cohort 1 will receive treatments that include immunotherapy (rilvegostomig or nivolumab) while Cohort 2 will not.
AstraZeneca is the trial sponsor, and patients will be recruited from Asia/the Americas/European Union/Rest of World. The trial will include about 2310 participants, all 18 years of age or older with advanced or metastatic gastroesophageal cancer with CLDN18.2 but not HER2 proteins. Participants will receive treatment until it is no longer benefiting them, their cancer gets worse, they have to start a new cancer therapy, or they leave the trial for another reason.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
26/SC/0052
Date of REC Opinion
21 Apr 2026
REC opinion
Further Information Favourable Opinion