Day one biopharmaceuticals trial#

Secondary and exploratory endpoints include safety, duration of response, progression-free survival, and time to response.

The primary endpoint will be overall response rate (ORR) as assessed by RECIST version 1.1 criteria. In the Phase 2 monotherapy portion, patients will be enrolled either into a melanoma cohort or a 'tissue agnostic' cohort, and will receive oral DAY101 at a dose of 600mg once weekly. This study will accrue adults as well as adolescent patients as young as 12 years of age. The multi-center, open-label umbrella study, FIRELIGHT-1, will evaluate the safety and efficacy of DAY101 in patients with recurrent or progressive solid tumors with activating RAF alterations. “Expanding the development of DAY101 beyond pediatric low-grade glioma represents an important step in our overall development strategy for this promising program, and we look forward to enrolling additional RAF-altered solid tumor patients in this Phase 2 monotherapy study.” “DAY101 has demonstrated encouraging anti-tumor activity as a monotherapy in patient populations where MAPK pathway alterations are believed to play an important role in driving disease progression,” said Samuel Blackman, M.D., Ph.D., co-founder and chief medical officer of Day One. DAY101 is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway.

Day one biopharmaceuticals trial#

22, 2021 (GLOBE NEWSWIRE) - Day One Biopharmaceuticals (Nasdaq: DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for patients of all ages with genomically-defined cancers, today announced that the first patient has been dosed in a Phase 2 clinical trial evaluating DAY101 as a monotherapy in patients with RAF-altered solid tumors. Phase 1b/2 Study Evaluating DAY101 in Combination with Pimasertib, Day One’s MEK Inhibitor, Expected to Begin in First Quarter of 2022.