Tests tovorafenib in children with returning or growing low-grade glioma
Tests tovorafenib in young patients with RAF-altered low-grade glioma or advanced solid tumors.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors
Key facts
- Where
- Zurich, SwitzerlandSee the site
- Phase
- Phase 2
Where in Switzerland
- Universitäts-Kinderspital Zürich - EleonorenstiftungZurich, SwitzerlandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Day One Biopharmaceuticals, Inc.
- Trial code
- NCT04775485EU 2024-510691-20-00
- Record updated
- 10 April 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Low Grade Glioma \& Low-Grade Glioma Extension: a relapsed or progressive LGG with documented known activating BRAF alteration; Advanced Solid Tumor: locally advanced or metastatic solid tumor with documented known or expected to be activating RAF fusion; Participants must have histopathologic verification of malignancy at either original diagnosis or relapse; Must have received at least one line of prior systemic therapy and have documented evidence of radiographic progression; Must have at least 1 measurable lesion as defined by RANO (Arms 1 \& 2) or RECIST v1.1 (Arm 3) criteria.
Exclusion: Participant's tumor has additional previously-known activating molecular alterations; Participant has symptoms of without radiographically recurrent or radiographically progressive disease; Known or suspected diagnosis of neurofibromatosis type 1 (NF-1) via genetic testing or current diagnostic criteria; Other inclusion/exclusion criteria as stipulated by protocol may apply.