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

Who is this study for? Pediatric patients with BRAF-altered, recurrent or progressive low-grade glioma and advanced solid tumors
What treatments are being studied? DAY101
Status: Recruiting
Location: See all (35) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 25
Healthy Volunteers: f
View:

• 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

Locations
United States
California
UCSF Benioff Children's Hospital
RECRUITING
San Francisco
Washington, D.c.
Children's National Medical Center
RECRUITING
Washington D.c.
Illinois
Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Maryland
Johns Hopkins Hospital
TERMINATED
Baltimore
Michigan
CS Mott Children's Hospital
RECRUITING
Ann Arbor
Missouri
St. Louis Children's Hospital
RECRUITING
St Louis
North Carolina
Duke Cancer Center
RECRUITING
Durham
New York
NYU Langone Health
RECRUITING
New York
Oregon
Doernbecher Children's Hospital Oregon & Health Science University
TERMINATED
Portland
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Texas
Texas Children's Hospital
RECRUITING
Houston
Utah
University of Utah
RECRUITING
Salt Lake City
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Other Locations
Australia
Queensland Children's Hospital
RECRUITING
Brisbane
Royal Children's Hospital
RECRUITING
Parkville
Perth Children's Hospital
RECRUITING
Perth
Sydney Children's Hospital
RECRUITING
Randwick
The Children's Hospital at Westmead
RECRUITING
Westmead
Canada
Centre Hospitalier Universitaire Ste-Justine
RECRUITING
Montreal
Montreal Children's Hospital
RECRUITING
Montreal
Centre Mère-Enfant Soleil du CHU
RECRUITING
Québec
Denmark
Rigshospitalet
RECRUITING
Copenhagen
Germany
Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Otto-Heubner-Centrum für Kinder
RECRUITING
Berlin
Hopp-Kindertumorzentrum Heidelberg (KiTZ), KiTZ Clinical Trial Unit (ZIPO)
RECRUITING
Heidelberg
Israel
Rambam Health Care Campus
RECRUITING
Haifa
Schneider Children's Medical Center of Israel
RECRUITING
Petah Tikva
The Chaim Sheba Medical Center
RECRUITING
Ramat Gan
Netherlands
Princess Maxima Center for Pediatric Oncology
RECRUITING
Utrecht
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital - Yonsei University
RECRUITING
Seoul
Singapore
KK Women's and Children's Hospital
RECRUITING
Singapore
Switzerland
Universitäts-Kinderspital Zürich - Eleonorenstiftung
RECRUITING
Zurich
United Kingdom
UCL Great Ormond Street Institute of Child Health
RECRUITING
London
Newcastle University
RECRUITING
Newcastle Upon Tyne
Contact Information
Primary
Day One Biopharmaceuticals, Inc.
firefly-1@dayonebio.com
650-484-0899
Time Frame
Start Date: 2021-04-22
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 141
Treatments
Experimental: Arm 1: Low-Grade Glioma
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).
Experimental: Arm 2: Low-Grade Glioma Expanded Access
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.
Experimental: Arm 3: Advanced Solid Tumor
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.
Related Therapeutic Areas
Sponsors
Leads: Day One Biopharmaceuticals, Inc.
Collaborators: Pacific Pediatric Neuro-Oncology Consortium

This content was sourced from clinicaltrials.gov