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Kinase Inhibitor

DAY101 for Brain Tumor (FIREFLY-1 Trial)

Phase 2
Recruiting
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:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights

FIREFLY-1 Trial Summary

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.

FIREFLY-1 Trial Eligibility Criteria

Inclusion Criteria

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

FIREFLY-1 Trial Timeline

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

FIREFLY-1 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)

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main purposes of this clinical experiment?

"According to the details reported by Day One Biopharmaceuticals, Inc., the primary outcome which will be tracked over a span of 48 months is Arm 3: Overall response rate (ORR) as evaluated using RECIST v1.1 criteria and reviewed independently by an IRC. Secondary outcomes include Arm 1: Visual acuity compared with baseline measured via Teller Acuity Cards® II; ORR assessed by Investigator based on RANO or RECIST criteria; and Arm 3: Time to response following DAY101 treatment commencement monitored through patient's best overall confirmed responses of CR or PR per RECIST v1.1 standards either from"

Answered by AI

Are there numerous locations in Canada that are conducting this medical research?

"21 medical centres across the USA, Canada and beyond are currently involved in this trial. Residents should select the closest clinic to them if they wish to join as it will reduce necessary travel."

Answered by AI

Who meets the criteria necessary to be approved for participation in this trial?

"This medical trial requires 140 individuals between the ages of 6 Months and 25 with glioma. To be admitted, applicants must fulfill a series of conditions such as having at least one lesion that meets RANO or RECIST v1.1 criteria (depending on arm), evidence of an activating BRAF alteration in arms 1 & 2, confirmation of LGG pathology coupled with molecular diagnosis for activating RAF fusion in arm 3, exposure to systemic therapy before enrollment along with evident radiographic progression."

Answered by AI

How many participants are being recruited for this research initiative?

"Yes, the records hosted on clinicaltrials.gov indicate that recruitment is still open for this research project. Launched on March 17th 2021 and most recently modified on September 29 2022, 140 subjects have to be recruited from 21 distinct sites."

Answered by AI

Are any opportunities available for patients to participate in this experiment?

"Clinicaltrials.gov confirms that this medical trial is currently recruiting patients, with its inception on March 17th 2021 and last update occurring September 29th 2022."

Answered by AI

To what extent does DAY101 pose a risk to patients?

"Our team at Power gave DAY101 a score of 2 on their safety scale because there is evidence to support its security, but no proof that it can be effectively applied as treatment."

Answered by AI

Does this research include participants younger than 45 years old?

"This research initiative is seeking participants aged between 6 months and 25 years."

Answered by AI
~36 spots leftby Mar 2025