This is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of Type II RAF (tovorafenib) in pediatric participants with low-grade glioma or advanced solid tumors. Qualifying genomic alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories prior to enrollment into any of the arms. The study will consist of a screening period, a treatment period, a long-term extension phase, end of treatment (EOT) visit(s), a safety follow-up visit, and long-term follow-up assessments.
This is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of Type II RAF (tovorafenib) in pediatric participants with low-grade glioma or advanced solid tumors. Qualifying genomic alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories prior to enrollment into any of the arms. The study will consist of a screening period, a treatment period, a long-term extension phase, end of treatment (EOT) visit(s), a safety follow-up visit, and long-term follow-up assessments.
A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors
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UCSF Benioff Children's Hospital, San Francisco, California, United States, 94143
Children's National Medical Center, Washington, District of Columbia, United States, 20010
Lurie Children's Hospital of Chicago, Chicago, Illinois, United States, 60611
Johns Hopkins Hospital, Baltimore, Maryland, United States, 21231
Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215
CS Mott Children's Hospital, Ann Arbor, Michigan, United States, 48109
St. Louis Children's Hospital, Saint Louis, Missouri, United States, 63110
NYU Langone Health, New York, New York, United States, 10016
Duke Cancer Center, Durham, North Carolina, United States, 27710
Doernbecher Children's Hospital Oregon & Health Science University, Portland, Oregon, United States, 97239
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
6 Months to 25 Years
ALL
No
Day One Biopharmaceuticals, Inc.,
2027-05-31