A Study to Evaluate DAY101 in Pediatric and Young Adult Patients With Relapsed or Progressive Low-Grade Glioma

• Status: Recruiting
• Trial end date: 2024-02-28
• Target enrollment: 0
• Participant gender: All

Summary

FIREFLY-1 is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of oral pan-RAF inhibitor DAY101 in pediatric, adolescent, and young adult patients with recurrent or progressive low-grade glioma harboring a known BRAF alteration.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Day One Biopharmaceuticals, Inc.
• Collaborator: Pacific Pediatric Neuro-Oncology Consortium

Criteria

Inclusion Criteria:

• Age 6 months to 25 years with a relapsed or progressive LGG with known activating BRAF alteration

• Confirmation of histopathologic diagnosis of LGG and molecular diagnosis of activating BRAF alteration

• Must have received at least one line of systemic therapy and have evidence of radiographic progression

• Must have at least 1 measurable lesion as defined by RANO criteria

Exclusion Criteria:

• Patient's tumor has additional previously-known activating molecular alterations

• Patient has symptoms of clinical progression in the absence of radiographic progression

• Known or suspected diagnosis of neurofibromatosis type 1 (NF-1)

• Other inclusion/exclusion criteria as stipulated by protocol may apply