DAY101 for Brain Tumor
(FIREFLY-1 Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing a new pill called DAY101 in young patients with certain brain tumors or advanced cancers. The pill works by blocking proteins that help cancer cells grow. The goal is to see if this treatment can control the disease in patients who have specific genetic changes.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug DAY101 (Tovorafenib) for brain tumors?
What safety data exists for the treatment Tovorafenib (DAY101) in humans?
In the FIREFLY-1 trial for pediatric low-grade glioma, Tovorafenib (DAY101) was generally safe but had some side effects. Common side effects included changes in hair color, increased levels of a muscle enzyme, and anemia (low red blood cell count). More severe side effects occurred in 42% of patients, and 7% of patients stopped treatment due to these effects.23678
What makes the drug DAY101 (Tovorafenib) unique for treating brain tumors?
DAY101 (Tovorafenib) is unique because it is an oral drug specifically targeting BRAF alterations, which are common in pediatric low-grade gliomas. Unlike standard chemotherapy, it is a selective type II RAF inhibitor that penetrates the central nervous system, offering a targeted approach for tumors with BRAF mutations.1291011
Eligibility Criteria
This trial is for young patients aged 6 months to 25 years with relapsed or progressive low-grade glioma (LGG) or advanced solid tumors that have a specific BRAF gene change. Participants must have at least one measurable tumor and, for certain arms of the study, must have tried at least one other treatment before joining.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tovorafenib weekly according to dose rounding guidelines and their baseline body surface area
End of Treatment (EOT) Visit
Participants undergo assessments to evaluate the end of treatment outcomes
Safety Follow-up
Participants are monitored for safety after the end of treatment
Long-term Follow-up
Participants are monitored for long-term safety and efficacy outcomes
Treatment Details
Interventions
- DAY101
DAY101 is already approved in United States for the following indications:
- Pediatric low-grade glioma with BRAF gene mutations
Find a Clinic Near You
Who Is Running the Clinical Trial?
Day One Biopharmaceuticals, Inc.
Lead Sponsor
Pacific Pediatric Neuro-Oncology Consortium
Collaborator