Study on DAY101 for Children and Young Adults with Returning or Growing Low-Grade Glioma and Advanced Solid Tumors

Sponsor: Day One Biopharmaceuticals, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04775485

Provider View

This clinical trial is testing the safety and effectiveness of a new oral medication, DAY101, in children and young adults with low-grade glioma or advanced solid tumors that have specific genetic changes.

Patient Parameters

Program Overview

The FIREFLY-1 study is a Phase 2 trial being conducted at multiple centers to evaluate the safety and effectiveness of DAY101, an oral medication, in children, adolescents, and young adults with low-grade glioma or advanced solid tumors that have a specific genetic change known as a RAF alteration.

Description

The study includes three groups:

  • Group 1 (Low-Grade Glioma): Patients aged 6 months to 25 years with low-grade glioma that has returned or is growing, and has a specific BRAF genetic change.
  • Group 2 (Low-Grade Glioma Expanded Access): Similar to Group 1, but includes patients with other RAF genetic changes. This group will open based on safety recommendations.
  • Group 3 (Advanced Solid Tumor): Patients aged 6 months to 25 years with advanced solid tumors that have a specific RAF genetic change.

Participants will take DAY101, a medication that targets RAF genetic changes, for up to 26 cycles (about 24 months). The medication is taken as a tablet once a week, with each cycle lasting 28 days. Treatment will continue unless the disease progresses, side effects become unacceptable, or the patient chooses to stop.

Patients will have scans every three cycles to check the status of their disease. If the disease progresses, patients may still continue the treatment if it is believed to be beneficial.

DAY101 is given as a tablet at a dose based on body size, not exceeding 600 mg per week.

Eligibility Criteria

Inclusion Criteria

  • Aged 6 months to 25 years.
  • For Groups 1 & 2: Have low-grade glioma that has returned or is growing, with a specific BRAF genetic change.
  • For Group 3: Have an advanced solid tumor with a specific RAF genetic change.
  • Must have had at least one previous treatment and show disease progression on scans.
  • Must have at least one measurable tumor based on specific criteria.

Exclusion Criteria

  • Tumor has other known genetic changes.
  • Symptoms of disease progression without evidence on scans.
  • Known or suspected neurofibromatosis type 1 (NF-1).
  • Other criteria may apply as per the study protocol.

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