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Clinical Trials in Italy / NCT05566795
Active, not recruiting Phase 3

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 Italy 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)

Tovorafenib →Chemotherapeutic 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
No
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)

FacilityCityRegionStatus
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 Italy