Summary

Eligibility
for people ages 6 months to 25 years (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

Summary

This is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of Type II RAF (tovorafenib) in pediatric participants with low-grade glioma or advanced solid tumors. Qualifying genomic alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories prior to enrollment into any of the arms. The study will consist of a screening period, a treatment period, a long-term extension phase, end of treatment (EOT) visit(s), a safety follow-up visit, and long-term follow-up assessments.

Official Title

FIREFLY-1: A Phase 2, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients With RAF-Altered, Recurrent or Progressive Low-Grade Glioma and Advanced Solid Tumors

Keywords

Low-grade Glioma, Advanced Solid Tumor, FIREFLY-1, DAY101, Tovorafenib, Glioma, Low-Grade Glioma Expanded Access

Eligibility

You can join if…

Open to people ages 6 months to 25 years

  • 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

You CAN'T join if...

  • 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

Locations

  • UCSF Benioff Children's Hospital accepting new patients
    San Francisco California 94143 United States
  • Doernbecher Children's Hospital Oregon & Health Science University terminated
    Portland Oregon 97239 United States
  • University of Utah accepting new patients
    Salt Lake City Utah 84113 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Day One Biopharmaceuticals, Inc.
ID
NCT04775485
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 141 study participants
Last Updated