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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2130

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Gastric Cancer
  • Gastroesophageal Junction Adenocarcinoma
  • Esophageal Cancer

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-03
Primary Completion
2029-08-16
Completion
2031-10-27
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07431281 on ClinicalTrials.gov