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Phase 2 Tovorafenib for Low-Grade Glioma and Advanced Solid Tumors

This study is testing a drug called Tovorafenib in children and young adults (ages 6 months to 25 years) who have low-grade glioma (a type of brain tumor) or advanced solid tumors that have come back or are getting worse. Tovorafenib is an oral medication that targets specific changes in cancer cells called RAF alterations. To join, your tumor must have a known BRAF alteration for low-grade glioma, or a RAF fusion for advanced solid tumors. Researchers want to see how well Tovorafenib works to shrink tumors and if it causes any side effects. This study aims to enroll 141 participants.

Study design
This is a Phase 2, multi-center, open-label study, meaning both you and your doctors will know you are receiving Tovorafenib. It plans to enroll 141 participants.
What's involved
The study involves a screening period, a treatment period, a long-term extension phase, and several follow-up visits after treatment ends.
Compensation
Not stated in the trial record.
Follow-up
Participants will have safety and long-term follow-up assessments after treatment, with primary endpoints measured for up to 48 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04775485

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

Recruiting
PHASE2Ages 6–25InterventionalTreatment
Day One Biopharmaceuticals, Inc.
~141 participants
Updated 2025-04-10 on ClinicalTrials.gov
What's tested:Tovorafenib

At a glance

Recruiting sites
33 of 35 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Arm 1: Overall response rate
Measured over Up to 48 months
+4 more outcomes measured

Conditions

Low-grade Glioma
Advanced Solid Tumor

Explore related trials

Low Grade GliomaSolid NeoplasmBRAF GeneRAF1 wt Allele

Where it's being run

35 sites across 24 states
Australia5
Quebec3
Israel3
Germany2
South Korea2
United Kingdom2
California1
District of Columbia1

Who to contact

Day One Biopharmaceuticals, Inc.
[email protected]
650-484-0899
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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.

What this trial measures

  • Arm 1: Overall response rateUp to 48 months

    ORR is defined as percentage of participants with best overall confirmed response of complete response (CR) or partial response (PR) by the Response Assessment in Neuro-Oncology - high-grade glioma (RANO-HGG) criteria.

  • Arm 2: Number of participants reporting adverse eventsUp to 48 months

    An adverse event (AE) is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  • Arm 2: Number of participants with clinically significant changes in clinical chemistry parametersUp to 48 months
  • Arm 2: Number of participants with clinically significant changes in hematology parametersUp to 48 months
  • Arm 3: Overall response rateUp to 48 months

    Determined by the treating investigator and measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or RANO-HGG criteria, as appropriate.