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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: 06 Aug 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

  • 23 Jul 2025 Planned End Date changed from 18 Aug 2025 to 20 Jun 2026.
  • 30 Jun 2025 Interim results presented in an Amgen Media Release.
  • 30 Jun 2025 According to Zai Lab media release,Detailed results from this trial will be shared at a future medical meeting.

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