Study Comparing DAY101 and Standard Chemotherapy in Children with Low-Grade Glioma Needing First-Time Treatment

Sponsor: Day One Biopharmaceuticals, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05566795

Provider View

This clinical trial is testing a new drug, tovorafenib, against standard chemotherapy in children and young adults with low-grade glioma, a type of brain tumor, to see which treatment is more effective and safe.

Patient Parameters

Program Overview

This study is a global Phase 3 trial that compares the effectiveness and safety of a new drug called tovorafenib with standard chemotherapy treatments in children and young adults with low-grade glioma (LGG) who need their first systemic treatment. The trial aims to find out which treatment works better in controlling the tumor.

Description

In this study, about 400 patients with low-grade glioma who have not received treatment before will be randomly assigned to one of two groups:

  • Group 1 (Tovorafenib): Patients will receive the drug tovorafenib in cycles that repeat every 28 days, as long as the disease does not get worse. Treatment will continue until the tumor progresses, side effects become unacceptable, the patient decides to stop, or the study ends.

  • Group 2 (Standard Chemotherapy): Patients will receive one of three standard chemotherapy options chosen by their doctor before the study starts. These options include the COG-V/C regimen, the SIOPe-LGG-V/C regimen, or the VBL regimen. Treatment will continue until the therapy is completed, the tumor progresses, side effects become unacceptable, the patient decides to stop, or the study ends.

If the disease progresses, patients will be evaluated based on specific criteria to confirm the progression. Doctors are encouraged to discuss any early signs of progression with the study team before making changes to the treatment plan. Patients may continue treatment even if the disease shows signs of progression.

Eligibility Criteria

Inclusion Criteria

  • Under 25 years old with low-grade glioma and a specific RAF gene change.
  • Diagnosed with glioma or a similar type of brain tumor.
  • Have at least one tumor that can be measured by scans.
  • Need first-time systemic treatment for the tumor.

Exclusion Criteria

  • Have certain types of brain tumors like Schwannoma or Subependymal Giant Cell Astrocytoma.
  • Have additional genetic changes in the tumor, such as IDH 1/2 mutation or Histone H3 mutation.
  • Have a known or suspected diagnosis of neurofibromatosis Type 1 or 2.
  • Have received any previous non-surgical cancer treatment for this condition, including chemotherapy or radiation.

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