A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors

Launched by DAY ONE BIOPHARMACEUTICALS, INC. · Feb 25, 2021

Keywords

ClinConnect Summary

This clinical trial, called FIREFLY-1, is studying a new medication called DAY101 for children and young adults with certain types of brain tumors, specifically low-grade gliomas and advanced solid tumors that have a known genetic change called a RAF alteration. The goal is to see how safe and effective this oral medication is for patients aged 6 months to 25 years who have had their tumors return or get worse after previous treatment.

To participate, patients must have a confirmed diagnosis of low-grade glioma with a specific genetic change or an advanced solid tumor with similar characteristics. They should have already received at least one type of treatment and show signs that their disease has progressed. Throughout the trial, participants will receive the medication and will be monitored closely to assess its effects. This study is currently recruiting participants and aims to provide valuable information about a potential new treatment option for these young patients.

Gender

ALL

Eligibility criteria

• 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