Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
0 - 25
Clinical summary
Summary
The study will consist of a screening period, a treatment period, a long-term extension phase, end of treatment visits, a safety follow-up visit, and long-term follow-up assessments.
The study has three treatment arms, and participants will be allocated to an arm based on their specific cancer type. All arms will receive the same treatment. Participants will receive DAY101 (also known as tovorafenib).
All participants must have received at least one prior line of systemic therapy and have documented evidence of progression.
- Arm 1: recurrent or progressive low-grade glioma with activating BRAF alteration
- Arm 2: recurrent or progressive low-grade glioma with activating BRAF alteration expanded acccess
- Arm 3: Advanced solid tumours with known or expected to be activating RAF fusion
Conditions
This trial is treating people with low-grade glioma or advanced solid tumours
Eligibility
Inclusion
- Low Grade Glioma & Low-Grade Glioma Extension: a relapsed or progressive LGG with documented known activating BRAF alteration.
- Advanced Solid Tumor: locally advanced or metastatic solid tumor with documented known or expected to be activating RAF fusion.
- Participants 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.
- Must have at least 1 measurable lesion as defined by RANO (Arms 1 & 2) or RECIST v1.1 (Arm 3) criteria
Exclusion
- Participant's tumor has additional previously-known activating molecular alterations.
- Participant has symptoms of without radiographically recurrent or radiographically progressive disease.
- Known or suspected diagnosis of neurofibromatosis type 1 (NF-1) via genetic testing or current diagnostic criteria.
Other inclusion/exclusion criteria as stipulated by protocol may apply
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.
Exclusion
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Day One Biopharmaceuticals, Inc.
Scientific Title
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
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