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Kinase Inhibitor

DAY101 for Brain Tumor (FIREFLY-1 Trial)

Phase 2
Research Sponsored by Day One Biopharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Arm 3: locally advanced or metastatic solid tumor with documented known or expected to be activating RAF fusion
Age 6 months to 25 years with:
Must not have
Known or suspected diagnosis of neurofibromatosis type 1 (NF-1)
Patient's tumor has additional previously-known activating molecular alterations
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights


This trial is studying a BRAF inhibitor as a possible treatment for pediatric, adolescent, and young adult patients with cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
The FIREFLY-1 study is testing DAY101, an oral medication designed to inhibit a protein called pan-RAF which may be involved in tumor growth. The goal is to see if it's safe and effective in children and young adults with brain tumors or other solid tumors with BRAF alterations.See study design
What are the potential side effects?
While not specified here, similar drugs targeting proteins like RAF can cause side effects such as rash, fatigue, joint pain, heart problems, and vision changes. Each patient's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My cancer is advanced or has spread, and tests show a RAF fusion.
I am between 6 months and 25 years old.
My low-grade glioma has returned or worsened with a known BRAF mutation.
My low-grade glioma has a confirmed BRAF gene mutation.
I've had treatment for my condition and my scans show it's getting worse.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
I have been diagnosed with or suspected to have neurofibromatosis type 1.
My tumor has other known gene changes that help it grow.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Arm 1: Overall response rate (ORR) by independent radiology review committee (IRC) based on RANO criteria
Arm 2: Assess the safety and tolerability of DAY101
Arm 3: Overall response rate (ORR) by independent radiology review committee (IRC) based on RECIST v1.1 criteria
Secondary outcome measures
Upper arm
Arm 3: Clinical benefit rate based on the proportion of patients with best overall response using RECIST v1.1 criteria
Arm 3: Duration of response (DOR) with best overall response of CR or PR using RECIST v1.1 criteria by 1) an IRC and 2) the treating Investigator
+11 more
Other outcome measures
Arm 1: Compare the response and time to progression following initiation of DAY101 to that of the prior line of systemic therapy
Arm 3: Determine the durability of response following discontinuation of DAY101 for patients with a radiographic response to DAY101 (CR or PR as based on RECIST v1.1 criteria) as determined by 1) an IRC and 2) the treating Investigator
Arms 1 & 2: Characterize changes in apparent diffusion coefficients following treatment with DAY101 using diffusion-weighted imaging analysis
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm #3Experimental Treatment1 Intervention
Pediatric patients with advanced solid tumors treated with DAY101
Group II: Arm #2Experimental Treatment1 Intervention
Expanded access arm of pediatric patients with low-grade glioma treated with DAY101
Group III: Arm #1Experimental Treatment1 Intervention
Pediatric patients with low-grade glioma treated with DAY101 (Registrational Arm)

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Low Grade Glioma (LGG) include surgery, radiation therapy, and chemotherapy. Targeted therapies, such as pan-RAF inhibitors like DAY101, are designed to block the activity of RAF proteins, which are involved in cell division and survival pathways. By inhibiting these proteins, pan-RAF inhibitors can reduce tumor growth and proliferation. This is particularly important for LGG patients with RAF alterations, as these targeted treatments can offer a more personalized and potentially effective approach compared to traditional therapies. Understanding these mechanisms helps patients and doctors make informed decisions about treatment options that are tailored to the genetic profile of the tumor.

Find a Location

Who is running the clinical trial?

Day One Biopharmaceuticals, Inc.Lead Sponsor
6 Previous Clinical Trials
750 Total Patients Enrolled
Pacific Pediatric Neuro-Oncology ConsortiumOTHER
14 Previous Clinical Trials
597 Total Patients Enrolled

Media Library

DAY101 (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04775485 — Phase 2
Low Grade Glioma Research Study Groups: Arm #1, Arm #3, Arm #2
Low Grade Glioma Clinical Trial 2023: DAY101 Highlights & Side Effects. Trial Name: NCT04775485 — Phase 2
DAY101 (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04775485 — Phase 2
~33 spots leftby Jul 2025