Trial Identifiers
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Scientific Title
A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Commercial Sponsor
Astellas Pharma Inc.
Summary
Patients in this trial will be randomised into one of two treatment arms. In Experimental Arm A, patients will receive a loading dose of zolbetuximab at Cycle 1 Day 1 followed by a lower dose in subsequent cycles every 3 weeks. Additionally, participants will receive 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 cycles (each cycle has 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. In Placebo Arm B, patients will receive a placebo starting at Cycle 1 Day 1 and every 3 weeks thereafter. Additionally, participants will receive 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 cycles (each cycle has 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. All patients in this trial may continue to receive fluorouracil (5-FU) and leucovorin at the investigator's discretion until the subject meets study treatment discontinuation criteria.