LOGGIC/FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients With Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy

Trial ID: NCT05566795

Interventional - Phase 3 - Active, not recruiting

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

Conditions

• Low-grade Glioma
• Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma
• Pediatric Low-grade Glioma

Interventions

• Tovorafenib
• Chemotherapeutic Agent

Eligibility

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

• Participant 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
• Participant's tumor has additional pathogenic molecular alterations, including but not limited to a) isocitrate dehydrogenase (IDH) 1/2 mutation, b) Histone H3 mutation, and c) neurofibromatosis Type 1 (NF-1) loss of function alteration.
• Known or suspected diagnosis of NF-1/ neurofibromatosis Type 2 (NF-2).
• Prior or ongoing nonsurgical anticancer therapy for this indication (eg, chemotherapy, oral/IV targeted therapy) including radiation.

Sponsor

Day One Biopharmaceuticals, Inc., SIOPe Brain Tumor Group LOGGIC Consortium

Source: ClinicalTrials.gov

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