At a glance
ClinicalIndex Comparison Record- ✓Relapsed or progressive low-grade glioma with documented activating BRAF alteration
- ✓Locally advanced or metastatic solid tumor with documented activating RAF fusion
- ✓Histopathologic verification of malignancy at original diagnosis or relapse
- ✓At least one prior line of systemic therapy with documented radiographic progression
- ✕Tumor with additional previously-known activating molecular alterations
- ✕Symptoms without radiographically recurrent or progressive disease
- ✕Known or suspected diagnosis of neurofibromatosis type 1 (NF-1)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Tovorafenib for Low-grade Glioma and Advanced Solid Tumor. Currently recruiting, targeting 141 participants across 35 sites in 11 countries.
Detailed 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.
Study Details
Timeline
Interventions
Tovorafenib is an oral Type II RAF kinase inhibitor available in 100 mg immediate-release tablet or 25 mg/milliliter (mL) powder for reconstitution.