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Clinical trial

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

NCT06901531 is registered in ClinicalTrials.gov with Astellas Pharma Global Development, Inc. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Astellas Pharma Global Development, Inc.
Phase
Phase 3
Overall status
Recruiting
Start date
May 22, 2025
Completion date
September 30, 2028
Enrollment
500 (estimated)
Sites
251

Conditions

As the registry lists them; a condition with its own page is linked.

locally advanced unresectable gastric adenocarcinoma or cancer, locally advanced unresectable gastroesophageal junction (gej) adenocarcinoma or cancer, metastatic gastric adenocarcinoma or cancer, metastatic gastroesophageal junction (gej) adenocarcinoma