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NCT04775485RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 10 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
141 (estimated)
First submitted
3 Feb 2021
Start date
22 Apr 2021
Primary completion date
31 May 2027
Lead sponsor
Day One Biopharmaceuticals, Inc.
NCT number
NCT04775485
EU CT number
2024-510691-20-00
EudraCT number
2020-003657-30

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 141
  • From 22 Apr 2021 to the primary completion date, 31 May 2027
  • 35 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participant's tumor has additional previously-known activating molecular alterations.

Other illness

  • Participant has symptoms of without radiographically recurrent or radiographically progressive disease.

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 6 months to 25 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (35)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Queensland Children's Hospital
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BrisbaneAustraliaRecruiting
Royal Children's Hospital
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ParkvilleAustraliaRecruiting
Perth Children's Hospital
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PerthAustraliaRecruiting
Sydney Children's Hospital
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RandwickAustraliaRecruiting
The Children's Hospital at Westmead
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WestmeadAustraliaRecruiting
Montreal Children's Hospital
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MontrealCanadaRecruiting
Centre Hospitalier Universitaire Ste-Justine
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MontrealCanadaRecruiting
Centre Mère-Enfant Soleil du CHU
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QuébecCanadaRecruiting
Universitäts-Kinderspital Zürich - Eleonorenstiftung
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ZurichSwitzerlandRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyRecruiting
Rigshospitalet
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Copenhagen OeDenmarkRecruiting
UCL Great Ormond Street Institute of Child Health
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LondonUnited KingdomRecruiting
Newcastle University
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Newcastle upon TyneUnited KingdomRecruiting
Rambam Health Care Campus
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HaifaIsraelRecruiting
Schneider Children's Medical Center of Israel
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Petah TikvaIsraelRecruiting
The Chaim Sheba Medical Center
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Ramat GanIsraelRecruiting
Severance Hospital Yonsei University
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Prinses Maxima Centrum voor Kinderoncologie B.V.
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UtrechtNetherlandsRecruiting
KK Women's and Children's Hospital
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SingaporeSingaporeRecruiting
CS Mott Children's Hospital
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Ann ArborUnited StatesRecruiting
Johns Hopkins Hospital
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BaltimoreUnited StatesTerminated
Dana-Farber Cancer Institute
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BostonUnited StatesRecruiting
Lurie Children's Hospital of Chicago
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ChicagoUnited StatesRecruiting
Duke Cancer Center
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DurhamUnited StatesRecruiting
Texas Children's Hospital
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HoustonUnited StatesRecruiting
NYU Langone Health
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New YorkUnited StatesRecruiting
Children's Hospital of Philadelphia
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PhiladelphiaUnited StatesRecruiting
Doernbecher Children's Hospital Oregon Health & Science University
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PortlandUnited StatesTerminated
University of Utah
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Salt Lake CityUnited StatesRecruiting
UCSF Benioff Children's Hospital
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San FranciscoUnited StatesRecruiting
Seattle Children's Hospital
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SeattleUnited StatesRecruiting
St. Louis Children's Hospital
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St LouisUnited StatesRecruiting
Children's National Medical Center
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Washington D.C.United StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.