DAY101 for Brain Tumor

(FIREFLY-1 Trial)

Recruiting at 37 trial locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Day One Biopharmaceuticals, Inc.

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

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.

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

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.

Exclusion Criteria

There may be additional criteria for participation in the study as specified in the protocol.

I feel my cancer is getting worse even though scans don't show it.

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

Treatment Details

Interventions

• DAY101 (Kinase Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Arm #3 Experimental Treatment 1 Intervention

Pediatric patients with advanced solid tumors treated with DAY101

Group II: Arm #2 Experimental Treatment 1 Intervention

Expanded access arm of pediatric patients with low-grade glioma treated with DAY101

Group III: Arm #1 Experimental Treatment 1 Intervention

Pediatric patients with low-grade glioma treated with DAY101 (Registrational Arm)

Who Is Running the Clinical Trial?

Day One Biopharmaceuticals, Inc.

Lead Sponsor

Trials

8

Recruited

1,100+

Pacific Pediatric Neuro-Oncology Consortium

Collaborator

Trials

16

Recruited

840+