A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors

ClinicalTrials.gov ID: NCT04775485

Public ClinicalTrials.gov record NCT04775485. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 7, 2026, 1:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Study identification

NCT ID: NCT04775485
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Day One Biopharmaceuticals, Inc.; Industry
Enrollment: 141 participants

Conditions and interventions

Conditions

Interventions

Tovorafenib Drug

Drug

Eligibility (public fields only)

Age range: 6 Months to 25 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 21, 2021
Primary completion: May 30, 2027
Completion: May 30, 2027
Last update posted: Apr 9, 2025

2021 – 2027

United States locations

U.S. sites: 14
U.S. states: 14
U.S. cities: 14

Facility	City	State	ZIP	Site status
UCSF Benioff Children's Hospital	San Francisco	California	94143	Recruiting
Children's National Medical Center	Washington D.C.	District of Columbia	20010	Recruiting
Lurie Children's Hospital of Chicago	Chicago	Illinois	60611	Recruiting
Johns Hopkins Hospital	Baltimore	Maryland	21231	Terminated
Dana-Farber Cancer Institute	Boston	Massachusetts	02215	Recruiting
CS Mott Children's Hospital	Ann Arbor	Michigan	48109	Recruiting
St. Louis Children's Hospital	St Louis	Missouri	63110	Recruiting
NYU Langone Health	New York	New York	10016	Recruiting
Duke Cancer Center	Durham	North Carolina	27710	Recruiting
Doernbecher Children's Hospital Oregon & Health Science University	Portland	Oregon	97239	Terminated
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	Recruiting
Texas Children's Hospital	Houston	Texas	77030	Recruiting
University of Utah	Salt Lake City	Utah	84113	Recruiting
Seattle Children's Hospital	Seattle	Washington	98105	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04775485, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Apr 9, 2025 · Synced May 7, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04775485 live on ClinicalTrials.gov.

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