A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors

Recruiting now · Phase 2

Conditions studied: Low-grade Glioma, Advanced Solid Tumor

In brief

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.

Key facts

Study ID

NCT04775485

Run by

Day One Biopharmaceuticals, Inc.

People needed

141

Starts

2021-04-22

Expected to finish

2027-05-31

Last updated by the study team

2025-04-10

Who can join

Age: 1 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Newcastle University — Newcastle upon Tyne, United Kingdom (enrolling)
• Children's National Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
• UCL Great Ormond Street Institute of Child Health — London, United Kingdom (enrolling)
• UCSF Benioff Children's Hospital — San Francisco, California, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• CS Mott Children's Hospital — Ann Arbor, Michigan, United States (enrolling)
• St. Louis Children's Hospital — St Louis, Missouri, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• Duke Cancer Center — Durham, North Carolina, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Texas Children's Hospital — Houston, Texas, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)
• Seattle Children's Hospital — Seattle, Washington, United States (enrolling)
• Queensland Children's Hospital — Brisbane, Australia (enrolling)
• Royal Children's Hospital — Parkville, Australia (enrolling)
• Perth Children's Hospital — Perth, Australia (enrolling)
• Sydney Children's Hospital — Randwick, Australia (enrolling)
• The Children's Hospital at Westmead — Westmead, Australia (enrolling)
• Centre Hospitalier Universitaire Ste-Justine — Montreal, Quebec, Canada (enrolling)
• Montreal Children's Hospital — Montreal, Quebec, Canada (enrolling)
• Centre Mère-Enfant Soleil du CHU — Québec, Quebec, Canada (enrolling)
• Rigshospitalet — Copenhagen, Denmark (enrolling)
• Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Otto-Heubner-Centrum für Kinder — Berlin, Germany (enrolling)
• Hopp-Kindertumorzentrum Heidelberg (KiTZ), KiTZ Clinical Trial Unit (ZIPO) — Heidelberg, Germany (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.