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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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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: 04 Sep 2024

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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

    • 26 Jul 2024 According to an Astellas Pharma media release, company Receives Positive Committee for Medicinal Products for Human Use (CHMP) Opinion for Zolbetuximab in the European Union, based on the results from the Phase 3 SPOTLIGHT and GLOW clinical trials.
    • 04 Jun 2024 Results (At data cutoff (September 8, 2023), n=565 )assessing safety and efficacy of zolbetuximab + mFOLFOX6 as first-line (1L) treatment for patientswith locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma presented at the 60th Annual Meeting of the American Society of Clinical Oncology
    • 17 May 2024 Planned End Date changed from 31 May 2025 to 31 Mar 2025.

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