Evaluating Tovorafenib for Pediatric Low-Grade Glioma and Advanced Solid Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, multi-center, open-label study aims to assess the safety and efficacy of Tovorafenib in pediatric and young adult participants with relapsed or progressive low-grade glioma and advanced solid tumors. Participants will undergo genomic testing to identify qualifying alterations before enrollment. The study includes a screening period, treatment phase, long-term extension, and follow-up assessments to monitor safety and efficacy outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Participant's tumor has additional previously-known activating molecular alterations.
* Participant has symptoms of without radiographically recurrent or radiographically progressive disease.
* Known or suspected diagnosis of neurofibromatosis type 1 (NF-1) via genetic testing or current diagnostic criteria.

Other inclusion/exclusion criteria as stipulated by protocol may apply

Where it's running

• UCSF Benioff Children's Hospital
  San Francisco, California, United States Recruiting
• Children's National Medical Center
  Washington D.C., District of Columbia, United States Recruiting
• Lurie Children's Hospital of Chicago
  Chicago, Illinois, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• CS Mott Children's Hospital
  Ann Arbor, Michigan, United States Recruiting
• St. Louis Children's Hospital
  St Louis, Missouri, United States Recruiting

Study contacts

• Study coordinator: Day One Biopharmaceuticals, Inc.
• Email: firefly-1@dayonebio.com
• Phone: 650-484-0899

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.