A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination with Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-positive.

Disease Sites:

Gastric/Gastroesophageal

Staging:

Phase III

Age Group:

Adults

Therapies:

Chemotherapy - cytotoxic, Mol. targeted/Immunotherapy/Biologics

Drugs:

Capecitabine, Fluorouracil (5-FU), Leucovorin, Oxaliplatin, Pembrolizumab, Zolbetuximab

Principal Investigator(s):

Gibson, Mike

Scope:

International

Participating Institutions:

Vanderbilt University

Open Date:

12-12-2025

Trial Type:

Treatment

Protocol ID:

VICCGI24570

National Clinical Trial ID:

NCT06901531

Eligibility

Ages Eligible for Study:

Not Available

Genders Eligible for Study:

Not Available

Accepts Healthy Volunteers?:

Not Available