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Low-grade GliomaGeneticsChildren's healthDrugPhase 2

What this study is

This is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of Type II RAF (tovorafenib) in pediatric participants with low-grade glioma or advanced solid tumors. Qualifying genomic alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories prior to enrollment into any of the arms. The study will consist of a screening period, a treatment period, a long-term extension phase, end of treatment (EOT) visit(s), a safety follow-up visit, and long-term follow-up assessments.

What's being tested

  • Tovorafenib

    Intervention · DRUG

    Tovorafenib is an oral Type II RAF kinase inhibitor available in 100 mg immediate-release tablet or 25 mg/milliliter (mL) powder for reconstitution.

Study details

Official title
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
Sponsor
Day One Biopharmaceuticals, Inc.
Conditions
Low-grade Glioma · Advanced Solid Tumor
Enrolling
141 people
Starts
2021-04-22
Est. completion
2027-05-31
Design
Open-label, non-randomized, single group, Phase 2
Record
View on ClinicalTrials.gov ↗