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FIREFLY-1: A Phase 2, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients With RAF-Altered, Recurrent or Progressive Low-Grade Glioma and Advanced Solid Tumors

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Trial Profile

FIREFLY-1: A Phase 2, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients With RAF-Altered, Recurrent or Progressive Low-Grade Glioma and Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 05 Jun 2024

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At a glance

  • Drugs Tovorafenib (Primary) ; Tovorafenib (Primary)
  • Indications Glioma; Solid tumours
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms FIREFLY-1
  • Sponsors Day One Biopharmaceuticals
  • Most Recent Events

    • 04 Jun 2024 Results assessing additional follow-up on all cases of decreased growth velocity (GV), an adverse event of special interest (AESI), reported to the Sponsor's global safety database (GSDB) as of January 19, 2024, presented at the 60th Annual Meeting of the American Society of Clinical Oncology.
    • 06 May 2024 According to Day One Biopharmaceuticals media release, data from this study will be presented in a 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, May 31-June 4, 2024.
    • 25 Apr 2024 According to XOMA Corporation media release, the company announced today it has earned a $9 million milestone related to the U.S. Food and Drug Administrations (FDA) approval of Day One Biopharmaceuticals New Drug Application (NDA) for OJEMDA.
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