DAY101 vs. Standard of Care Chemotherapy in Pediatric Patients With Low-Grade Glioma Requiring First-Line Systemic Therapy

• Status: Not yet recruiting
• Trial end date: 2030-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate the efficacy, safety, and tolerability of DAY101 monotherapy versus standard of care (SoC) chemotherapy in patients with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring front-line systemic therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Day One Biopharmaceuticals, Inc.
• Collaborator: SIOPe Brain Tumor Group LOGGIC Consortium
• Treatments: Antineoplastic Agents

Criteria

Inclusion Criteria:

• Less than 25 years of age with LGG with known activating RAF alteration

• Histopathologic diagnosis of glioma or glioneuronal tumor

• At least one measurable lesion as defined by RANO criteria

• Meet indication for first-line systemic therapy

Exclusion Criteria:

• Patient has any of the following tumor-histological findings:

1. Schwannoma

2. Subependymal giant cell astrocytoma (Tuberous Sclerosis)

3. Diffuse intrinsic pontine glioma, even if histologically diagnosed as World Health Organization (WHO) Grade I-II

• Patient's tumor has additional activating molecular alterations

• Known or suspected diagnosis of neurofibromatosis Type 1 or 2 (NF-1/NF-2)

• Prior or ongoing nonsurgical anticancer therapy for this indication (eg, chemotherapy, oral/intravenous targeted therapy) including radiation