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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

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Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Jan 2025

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At a glance

  • Drugs Zolbetuximab (Primary) ; Fluorouracil; Folinic acid; Oxaliplatin
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms Spotlight
  • Sponsors Astellas Pharma Global Development

    • Most Recent Events

    • 05 Jan 2025 According to an Astellas Pharma media release, Professor Xu Jianming, is the lead principal investigator of this trial
    • 05 Jan 2025 According to an Astellas Pharma media release, based upon data from global Phase 3 GLOW and SPOTLIGHT ,China National Medical Products Administration (NMPA) has approved VYLOY (zolbetuximab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or GEJ adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive.
    • 18 Oct 2024 According to Astellas Pharma media release, the U.S. Food and Drug Administration (FDA) has approved VYLOYTM (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. The approval is based on results from the Phase 3 SPOTLIGHT and GLOW clinical trials.

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