drugset / Trial / 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

NCT07431281

Phase 3 Recruiting 2130 enrolled AstraZeneca
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2026-02-03
Primary completion
2029-08-16
Completion
2031-10-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody Intravenous
Subject Rilvegostomig Other / unclassified Intravenous
Subject Sonesitatug Vedotin Other / unclassified Intravenous
Background Capecitabine Small molecule Oral
Comparator Leucovorin Small molecule Intravenous
Comparator Oxaliplatin Small molecule Intravenous
Comparator fluorouracil Small molecule Intravenous
Comparator zolbetuximab Monoclonal antibody Intravenous