What side effects are associated with this type of intervention?

Common treatments for Low-Grade Glioma, such as chemotherapy and targeted therapies, can have a range of side effects. Chemotherapy often leads to alopecia (hair loss), fatigue, nausea, vomiting, and myelosuppression (reduced bone marrow activity). Targeted therapies, including RAF inhibitors like DAY101, may cause skin rashes, diarrhea, liver enzyme abnormalities, and fatigue. It's important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved pan-RAF inhibitors like DAY101 for the treatment of Low-Grade Glioma. However, targeted therapies and inhibitors that focus on similar pathways, such as BRAF inhibitors (e.g., vemurafenib and dabrafenib), have been explored in clinical trials for various gliomas. These treatments aim to target genetic mutations and alterations within the tumor cells, similar to the mechanism of action of DAY101.

What other types of research exist?

Promising novel alternatives to DAY101 for Low Grade Glioma patients include targeted therapies such as BRAF inhibitors (e.g., dabrafenib) and MEK inhibitors (e.g., trametinib), which have shown efficacy in tumors with specific genetic mutations. Additionally, immunotherapy agents like pembrolizumab and nivolumab are being explored for their potential benefits in glioma treatment. Clinical trials investigating these agents may provide viable options for patients in 2024.

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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:

Must not have

Known or suspected diagnosis of neurofibromatosis type 1 (NF-1)

Patient's tumor has additional previously-known activating molecular alterations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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

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My cancer is advanced or has spread, and tests show a RAF fusion.

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I am between 6 months and 25 years old.

Select...

My low-grade glioma has returned or worsened with a known BRAF mutation.

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My low-grade glioma has a confirmed BRAF gene mutation.

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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:

Select...

I have been diagnosed with or suspected to have neurofibromatosis type 1.

Select...

My tumor has other known gene changes that help it grow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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)

0 / 7Eligibility criteria met

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.