NCT07431281

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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,130 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in first-line (1L) Claudin18.2 (CLDN18.2)-positive, human epidermal growth factor receptor 2 (HER2)-negative, gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.

Detailed description

The purpose of this Phase III study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in 1L CLDN18.2-positive, HER2-negative gastric, GEJ, and esophageal adenocarcinoma, and the clinical performance of the investigation in vitro diagnostics (IVDs). The study will include 2 cohorts to provide a treatment option for all participants that are HER2-negative and CLDN18.2-positive. Cohort 1 will evaluate sonesitatug vedotin in combination with rilvegostomig with capecitabine in participants who are CLDN18.2-positive and programmed death-ligand 1 (PD-L1) positive. Cohort 2 will evaluate sonesitatug vedotin in combination with capecitabine in participants who are CLDN18.2-positive and PD-L1 negative or immune checkpoint inhibitor (ICI) ineligible.

Conditions

• Gastric Cancer
• Gastroesophageal Junction Adenocarcinoma
• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Sonesitatug vedotin	Intravenous
DRUG	Rilvegostomig	Intravenous
DRUG	Nivolumab	Intravenous
DRUG	Capecitabine	Oral
DRUG	5-Fluorouracil	Intravenous
DRUG	Oxaliplatin	Intravenous
DRUG	Zolbetuximab	Intravenous
DRUG	Leucovorin	Intravenous

Timeline

• Start date: 2026-02-03
• Primary completion: 2029-08-16
• Completion: 2031-10-27
• First posted: 2026-02-24
• Last updated: 2026-04-13

Locations

258 sites across 22 countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Hungary, India, Italy, Japan, Netherlands, Poland, Puerto Rico, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study