DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)

NCT05566795 · tracked via the Priya Life Science Ireland tracker

Sponsor

Day One Biopharmaceuticals, Inc.

Phase

Phase 3

Started

2023-02-27

Last updated

2026-05-14

Condition(s) studied

Low-grade GliomaRapidly Accelerated Fibrosarcoma (RAF) Altered GliomaPediatric Low-grade Glioma

Investigational drug(s) / intervention(s)

TovorafenibChemotherapeutic Agent

Tovorafenib: Oral Tablet Powder for Oral Suspension

Chemotherapeutic Agent: Intravenous solution for injection

Study summary

This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate the efficacy, safety, and tolerability of tovorafenib monotherapy versus standard of care (SoC) chemotherapy in participants with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring first-line systemic therapy.

Eligibility

Sex

ALL

Min age

—

Max age

25 Years

Healthy volunteers

Inclusion Criteria: * Less than 25 years of age with LGG with known activating RAF alteration. * Histopathologic diagnosis of glioma or glioneuronal tumor. * At least one measurable lesion as defined by RANO criteria. * Meet indication for first-line systemic therapy. Exclusion Criteria: * Participant has any of the following tumor-histological findings: 1. Schwannoma 2. Subependymal giant cell astrocytoma (Tuberous Sclerosis) 3. Diffuse intrinsic pontine glioma, even if histologically diagnosed as World Health Organization (WHO) Grade I-II * Participant's tumor has additional pathogenic molecular alterations, including but not limited to a) isocitrate dehydrogenase (IDH) 1/2 mutation, b) Histone H3 mutation, and c) neurofibromatosis Type 1 (NF-1) loss of function alteration. * Known or suspected diagnosis of NF-1/ neurofibromatosis Type 2 (NF-2). * Prior or ongoing nonsurgical anticancer therapy for this indication (eg, chemotherapy, oral/IV targeted therapy) including radiation.

Primary outcome measure(s)

Objective response rate (ORR) of tovorafenib monotherapy versus SoC chemotherapy — Up to 60 months
ORR assessed per Response Assessment in Pediatric Neuro Oncology (RAPNO) criteria by Independent Review Committee (IRC), and defined as the proportion of participants with overall confirmed response of complete response (CR), partial response (PR), or minor response (MR).

Trial sites (138)

Facility	City	Region
Children's of Alabama	Birmingham	Alabama
Phoenix Children's Hospital	Phoenix	Arizona
Children's Hospital Los Angeles	Los Angeles	California
Children's Hospital of Orange County Main Campus - Orange	Orange	California
Packard Children's Hospital Stanford	Palo Alto	California
UCSF Benioff Children's Hospital	San Francisco	California
Children's Hospital Colorado	Aurora	Colorado
Connecticut Children's Medical Center	Hartford	Connecticut
Children's National Medical Center	Washington D.C.	District of Columbia
University of Florida Health	Gainesville	Florida
Nicklaus Children's Hospital	Miami	Florida
Arnold Palmer Hospital for Children	Orlando	Florida
Johns Hopkins All Children's Hospital	St. Petersburg	Florida
Children's Healthcare of Atlanta	Atlanta	Georgia
Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
University of Chicago	Chicago	Illinois
Riley Hospital for Children at Indiana University Health	Indianapolis	Indiana
University of Iowa Hospitals Clinics	Iowa City	Iowa
Norton Children's Hospital	Louisville	Kentucky
Maine Children's Cancer Program	Scarborough	Maine
Dana-Farber Cancer Institute	Boston	Massachusetts
University of Michigan - - C.S. Mott Children's Hospital	Ann Arbor	Michigan
Children's Minnesota	Minneapolis	Minnesota
Childrens MS Cncr Ctr Bld Dsr	Jackson	Mississippi
St. Louis Children's Hospital	St Louis	Missouri
University of Nebraska Medical Center	Omaha	Nebraska
Albany Medical Center	Albany	New York
New York University Langone Health	New York	New York
Columbia University	New York	New York
University of Rochester	Rochester	New York
Duke Cancer Institute	Durham	North Carolina
Cleveland Clinic Main Campus	Cleveland	Ohio
Oregon Health Science University	Portland	Oregon
Dell Children's Medical Center of Central Texas	Austin	Texas
University of Texas Southwestern Medical Center	Dallas	Texas
Texas Children's Hospital	Houston	Texas
Seattle Children's Hospital	Seattle	Washington
University of Wisconsin - Madison	Madison	Wisconsin
Children's Health Queensland Hospital and Health Service	South Brisbane	Queensland
Perth Children's Hospital	Nedlands	Australia

+ 98 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05566795 on ClinicalTrials.gov ↗ ← All trials in Ireland