FIREFLY-1: A Phase 2, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients with BRAF-Altered, Recurrent or Progressive Low-Grade Glioma



The aim of the study is to find out whether treatment with DAY101 is safe and effective in pediatric patients with recurrent or progressive Low-Grade Glioma (LGG) with a change (alteration) in the BRAF gene. 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.

Patients between 6 and 25 years of age with relapsing / refractory or progressive LGG can participate in this study. A BRAF change in the tumors must be proven by molecular assays.

DAY101 is taken in tablet form once a week in 28-day cycles.

Main inclusion criteria

  • Children, adolescents and young adults with a relapsed or progressive LGG
  • Age ≥ 6 and ≤ 25 years
  • a documented known activating BRAF alteration, as identified through molecular assays
  • Karnofsky oder Lansky > 50
  • At least one measurable lesions as defined by RANA criteria


DAY One Therapeutics Inc.

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