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A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression

Trial Profile

A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression

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

Latest Information Update: 08 May 2025

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At a glance

  • Drugs Bemarituzumab (Primary) ; Fluorouracil; Folinic acid; Oxaliplatin
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms FORTITUDE-101
  • Sponsors Amgen

Most Recent Events

  • 01 May 2025 According to Zai Lab media release, Data readout is anticipated in Q2 2025.
  • 27 Feb 2025 According to Zai Lab media release, potential Biologics License Application (BLA) submission to NMPA in the first half of 2025.
  • 04 Feb 2025 According to an Amgen media release, Data readout is anticipated in H1 2025.

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