NCT04775485

A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors

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: Phase 2
• Study type: Interventional
• Enrollment: 141 (estimated)
• Sponsor: Day One Biopharmaceuticals, Inc. · Industry
• Sex: All
• Age: 6 Months – 25 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Low-grade Glioma
• Advanced Solid Tumor

Interventions

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

Timeline

• Start date: 2021-04-22
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2021-03-01
• Last updated: 2025-04-10

Locations

35 sites across 11 countries: United States, Australia, Canada, Denmark, Germany, Israel, Netherlands, Singapore, South Korea, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study