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 RAF-Altered, Recurrent or Progressive Low-Grade Glioma and Advanced Solid Tumors - DAY101-001

Day One Biopharmaceuticals Inc.0 个研究点目标入组 140 人开始时间: 2024年6月27日最近更新: 2024年8月21日

适应症

试验速览

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•Patients must be age 6 months to 25 years, inclusive, with: a) Arm 1 (Low-Grade Glioma): A relapsed or progressive low-grade glioma (LGG) with a documented known activating BRAF alteration. b) Arm 2 (Low-Grade Glioma Extension): A relapsed or progressive low-grade glioma with a documented known or expected to be activating BRAF mutation or RAF fusion. c) Arm 3 (Advanced Solid Tumor): Locally advanced or metastatic solid tumor with a documented known or expected to be activating RAF fusion., Patients must have histopathologic verification of malignancy at either original diagnosis or relapse., Must have received at least one line of prior systemic therapy and have documented evidence of radiographic progression (Arm 1 and Arm 2)., Patients must have evaluable and/or measurable disease as specified below: a) Arm 1 (Low-Grade Glioma):Must have at least one measurable lesion. b) Arm 2 (Low-Grade Glioma Extension): Must have evaluable and/or measurable disease c) Arm 3 (Advanced Solid Tumor): Must have at least one measurable lesion, Patients must have Karnofsky (those 16 years and older) or Lansky (those younger than 16 years) performance score of at least 50.

•Patient has symptoms of clinical progression without radiographically recurrent or radiographically progressive disease., Patient has history of any major disease, other than the primary malignancy under study, that might interfere with safe protocol participation, Patient has major surgery within 14 days (2 weeks) prior to C1D1, Patient has clinically significant active cardiovascular disease, or history of myocardial infarction, or deep vein thrombosis/pulmonary embolism within 6 months prior to C1D1, Patient is currently enrolled in any other investigational treatment study. Participation in a concurrent observational or bio-sampling study is allowed.

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