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A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors
NCT04775485 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Tovorafenib
Study Locations (20)
Other
- Queensland Children's Hospital — Brisbane
- Royal Children's Hospital — Parkville
- Perth Children's Hospital — Perth
- Sydney Children's Hospital — Randwick
- The Children's Hospital at Westmead — Westmead
California
- UCSF Benioff Children's Hospital — San Francisco
District of Columbia
- Children's National Medical Center — Washington D.C.
Illinois
- Lurie Children's Hospital of Chicago — Chicago
Maryland
- Johns Hopkins Hospital — Baltimore
Massachusetts
- Dana-Farber Cancer Institute — Boston
Michigan
- CS Mott Children's Hospital — Ann Arbor
Missouri
- St. Louis Children's Hospital — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2021-04-22 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04775485
The ClinicalTrials.gov registry entry for NCT04775485 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Day One Biopharmaceuticals, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 1 intervention — of which Tovorafenib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04775485 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Other, California, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04775485 about?
NCT04775485 is a clinical study titled "A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors". 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 L...
What is the current status of trial NCT04775485?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 141 participants. The study started on 2021-04-22. Estimated completion is 2027-05-31.
What conditions does trial NCT04775485 study?
This clinical trial studies the following conditions: Advanced Solid Tumor, Low-grade Glioma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04775485?
The interventions under investigation include: Tovorafenib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04775485?
This trial is sponsored by Day One Biopharmaceuticals, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04775485 being conducted?
This trial has 20 study locations across California, District of Columbia, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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