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A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors
Sponsor: Day One Biopharmaceuticals, Inc.
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.
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
Key Details
Gender
All
Age Range
6 Months - 25 Years
Study Type
INTERVENTIONAL
Enrollment
141
Start Date
2021-04-22
Completion Date
2027-05-31
Last Updated
2025-04-10
Healthy Volunteers
No
Conditions
Interventions
Tovorafenib
Tovorafenib is an oral Type II RAF kinase inhibitor available in 100 mg immediate-release tablet or 25 mg/milliliter (mL) powder for reconstitution.
Locations (35)
UCSF Benioff Children's Hospital
San Francisco, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
CS Mott Children's Hospital
Ann Arbor, Michigan, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
NYU Langone Health
New York, New York, United States
Duke Cancer Center
Durham, North Carolina, United States
Doernbecher Children's Hospital Oregon & Health Science University
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Texas Children's Hospital
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
Queensland Children's Hospital
Brisbane, Australia
Royal Children's Hospital
Parkville, Australia
Perth Children's Hospital
Perth, Australia
Sydney Children's Hospital
Randwick, Australia
The Children's Hospital at Westmead
Westmead, Australia
Centre Hospitalier Universitaire Ste-Justine
Montreal, Quebec, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
Centre Mère-Enfant Soleil du CHU
Québec, Quebec, Canada
Rigshospitalet
Copenhagen, Denmark
Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Otto-Heubner-Centrum für Kinder
Berlin, Germany
Hopp-Kindertumorzentrum Heidelberg (KiTZ), KiTZ Clinical Trial Unit (ZIPO)
Heidelberg, Germany
Rambam Health Care Campus
Haifa, Israel
Schneider Children's Medical Center of Israel
Petah Tikva, Israel
The Chaim Sheba Medical Center
Ramat Gan, Israel
Princess Maxima Center for Pediatric Oncology
Utrecht, Netherlands
KK Women's and Children's Hospital
Singapore, Singapore
Seoul National University Hospital
Seoul, South Korea
Severance Hospital - Yonsei University
Seoul, South Korea
Universitäts-Kinderspital Zürich - Eleonorenstiftung
Zurich, Switzerland
UCL Great Ormond Street Institute of Child Health
London, United Kingdom
Newcastle University
Newcastle upon Tyne, United Kingdom