Status:
RECRUITING
A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors
Lead Sponsor:
Day One Biopharmaceuticals, Inc.
Collaborating Sponsors:
Pacific Pediatric Neuro-Oncology Consortium
Conditions:
Low-grade Glioma
Advanced Solid Tumor
Eligibility:
All Genders
6-25 years
Phase:
PHASE2
Brief 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 ...
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.
- Other inclusion/exclusion criteria as stipulated by protocol may apply
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT04775485
Start Date
April 22 2021
End Date
May 31 2027
Last Update
April 10 2025
Active Locations (35)
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1
UCSF Benioff Children's Hospital
San Francisco, California, United States, 94143
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
3
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
4
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231