Trial Profile

A Phase 1b/2 Study Evaluating the Safety, Tolerability, Efficacy, and Pharmacokinetics of Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer (FORTITUDE-103)

Status: Recruiting

Phase of Trial: Phase I

Latest Information Update: 24 Aug 2025

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At a glance

Drugs Bemarituzumab (Primary) ; Capecitabine (Primary) ; Gimeracil/oteracil/tegafur (Primary) ; Nivolumab (Primary) ; Oxaliplatin (Primary)
Indications Gastric cancer; Oesophageal cancer
Focus Adverse reactions; Therapeutic Use
Acronyms FORTITUDE-103
Sponsors Amgen

20 Jul 2025 Planned number of patients changed from 80 to 70.
20 Jul 2025 Planned End Date changed from 1 Apr 2028 to 15 Aug 2028.
20 Jul 2025 Planned primary completion date changed from 17 Mar 2026 to 19 Jun 2026.

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