Title: “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”
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.
