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.
- Diseases
- Childhood cancers
- 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
Sites (35)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Queensland Children's Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
| Royal Children's Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Recruiting |
| Perth Children's Hospital Coordinator of this site? Confirm its status | Perth | Australia | Recruiting |
| Sydney Children's Hospital Coordinator of this site? Confirm its status | Randwick | Australia | Recruiting |
| The Children's Hospital at Westmead Coordinator of this site? Confirm its status | Westmead | Australia | Recruiting |
| Montreal Children's Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Centre Hospitalier Universitaire Ste-Justine Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Centre Mère-Enfant Soleil du CHU Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| Universitäts-Kinderspital Zürich - Eleonorenstiftung Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| UCL Great Ormond Street Institute of Child Health Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Newcastle University Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Recruiting |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Schneider Children's Medical Center of Israel Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| The Chaim Sheba Medical Center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Severance Hospital Yonsei University Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Prinses Maxima Centrum voor Kinderoncologie B.V. Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| KK Women's and Children's Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
| CS Mott Children's Hospital Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Terminated |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Lurie Children's Hospital of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Duke Cancer Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Texas Children's Hospital Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Doernbecher Children's Hospital Oregon Health & Science University Coordinator of this site? Confirm its status | Portland | United States | Terminated |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| UCSF Benioff Children's Hospital Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| St. Louis Children's Hospital Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Children's National Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.