Phase III Trial of Sonesitatug Vedotin with Capecitabine with or without Rilvegostomig for Advanced Claudin18.2-Positive, HER2-Negative Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of sonesitatug vedotin combined with capecitabine, with or without rilvegostomig, as a first-line treatment for people with Claudin18.2-positive, HER2-negative advanced or metastatic gastric, gastroesophageal junction, and esophageal adenocarcinoma. This Phase III study also assesses the performance of investigational in vitro diagnostics used to identify eligible patients. The trial includes two groups based on PD-L1 status and eligibility for immune checkpoint inhibitor therapy. Participants will be assigned to one of several treatment groups. Cohort 1 includes participants who are PD-L1 positive and eligible for immune checkpoint inhibitors, receiving sonesitatug vedotin, rilvegostomig, and capecitabine. Cohort 2 includes PD-L1 negative or ineligible participants receiving sonesitatug vedotin with capecitabine. Other treatment arms involve combinations including nivolumab, zolbetuximab, and chemotherapy regimens such as CAPOX or FOLFOX. During the study, participants will be monitored for up to approximately five years to assess progression-free survival and overall survival. Researchers will also evaluate response rates, duration of response, pharmacokinetics, immunogenicity, safety, and tolerability. Participants will undergo regular assessments, including imaging to measure tumors and laboratory tests to monitor health and treatment effects.

Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2