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A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors With FGFR2b Overexpression (FORTITUDE-301)

Trial Profile

A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors With FGFR2b Overexpression (FORTITUDE-301)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 26 Mar 2025

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At a glance

  • Drugs Bemarituzumab (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer; Carcinoma; Cervical cancer; Cholangiocarcinoma; Colorectal cancer; Endometrial cancer; Fallopian tube cancer; Head and neck cancer; Lung cancer; Male breast cancer; Oesophageal cancer; Ovarian cancer; Pancreatic cancer; Peritoneal cancer; Solid tumours; Squamous cell cancer; Triple negative breast cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms FORTITUDE-301
  • Sponsors Amgen
  • Most Recent Events

    • 19 Feb 2025 Planned End Date changed from 31 Dec 2027 to 30 Sep 2027.
    • 19 Feb 2025 Planned primary completion date changed from 11 Mar 2026 to 9 Dec 2025.
    • 23 Jan 2025 Planned End Date changed from 27 Jul 2027 to 31 Dec 2027.

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