LOGGIC/FIREFLY-2
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
DAY101 (Tovorafenib) vs. Standard of Care Chemotherapy in Pediatric Patients With Low-Grade Glioma Requiring First-Line Systemic Therapy
Recruiting
Summary
The 2-armed trial aims 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.
Randomization will take place 1:1 to either DAY101 (Arm 1) or an Investigator's choice of SoC chemotherapy (Arm 2).
DAY101 is a so-called Pan-RAF inhibitor, which blocks the activity of an important growth signaling pathway (MAPK / ERK) in the cancer cells and thus leads to the death of the cancer cells. The study therefore only treats patients whose tumor tissue has certain mutations in the BRAF gene, which lead to an excessive activation of the MAPK / ERK signaling pathway.
Main inclusion criteria
- Age ≤ 25 years
- Histopathologic Diagnosis of glioma or glioneuronal tumor
- LGG with known activating RAF alteration
- At least one measurable lesion as defined by RANO criteria
- Meet indication for first-line systemic therapy
Sponsor
DAY One Therapeutics Inc.