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Taking people in CanadaPhase 2

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.

Key facts

Who runs it
Day One Biopharmaceuticals, Inc.
Where
Montreal and Québec, CanadaSee the 3 sitesAlso in 10 other countries, 32 sites
Registry title
A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors
Status
Recruiting
Phase
Phase 2
People taking part
141 people, planned
Started
22 Apr 2021
Expected to end
31 May 2027
Type of study
Interventional, 3 groups
Treatments tested
  • Tovorafenib
Record updated
10 April 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and young adults with low-grade glioma or an advanced solid tumor that has a RAF gene change. The tumor must have come back or grown after treatment.

Age
6 months to 25 years
Sex
All sexes can join.
Disease stage
Low-grade glioma that came back or is growing, or a locally advanced or metastatic solid tumor. The cancer must be confirmed by tissue testing and have at least 1 measurable lesion.
Earlier treatment
Must have had at least one earlier treatment that works through the whole body, and imaging must show the disease has grown.
Biomarker or test result
Low-grade glioma needs a known activating BRAF change. Advanced solid tumor needs a known or expected activating RAF fusion.

Main reasons for not taking part

  • The tumor has other known activating gene changes
  • Symptoms but no recurrence or growth seen on imaging
  • Known or suspected neurofibromatosis type 1 (NF-1)

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Canada

Also in 10 other countries, 32 sites

  • Centre Hospitalier Universitaire Ste-JustineMontreal, CanadaContact: Day One Biopharmaceuticals, Inc.Taking people
  • Montreal Children's HospitalMontreal, CanadaContact: Day One Biopharmaceuticals, Inc.Taking people
  • Centre Mère-Enfant Soleil du CHUQuébec, CanadaContact: Day One Biopharmaceuticals, Inc.Taking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Arm 1: Low-Grade GliomaTreatment being tested

    Participants with recurrent or progressive low-grade glioma will receive 420 milligrams/meters square (mg/m\^2) of tovorafenib weekly according to dose rounding guidelines and according to their baseline body surface area (BSA).

    Treatment: Tovorafenib

  • Arm 2: Low-Grade Glioma Expanded AccessTreatment being tested

    Participants with recurrent or progressive low-grade glioma will receive 420 mg/m\^2 of tovorafenib weekly according to dose rounding guidelines and according to their baseline BSA.

    Treatment: Tovorafenib

  • Arm 3: Advanced Solid TumorTreatment being tested

    Participants with advanced solid tumors will receive 420 mg/m\^2) of tovorafenib weekly according to dose rounding guidelines and according to their baseline BSA.

    Treatment: Tovorafenib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
Tests tovorafenib in children with returning or growing low-grade gliomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
10 April 2025