Actively Recruiting
A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors
Led by Day One Biopharmaceuticals, Inc. · Updated on 2025-04-10
141
Participants Needed
35
Research Sites
318 weeks
Total Duration
On this page
Sponsors
D
Day One Biopharmaceuticals, Inc.
Lead Sponsor
P
Pacific Pediatric Neuro-Oncology Consortium
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Relapsed or progressive low-grade glioma with documented activating BRAF alteration
- Locally advanced or metastatic solid tumor with documented or expected activating RAF fusion
- Histopathologic verification of cancer at original diagnosis or relapse
- Received at least one prior systemic therapy with documented radiographic progression
- At least one measurable lesion by RANO (Arms 1 & 2) or RECIST v1.1 (Arm 3) criteria
You will not qualify if you...
- Tumor has additional previously-known activating molecular alterations
- Symptoms without radiographically recurrent or progressive disease
- Known or suspected neurofibromatosis type 1 (NF-1) diagnosis by genetic testing or criteria
- Other inclusion/exclusion criteria per protocol may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 35 locations
1
UCSF Benioff Children's Hospital
San Francisco, California, United States, 94143
Actively Recruiting
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
3
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
Terminated
5
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
CS Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
7
St. Louis Children's Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
8
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
9
Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
10
Doernbecher Children's Hospital Oregon & Health Science University
Portland, Oregon, United States, 97239
Terminated
11
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
12
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
13
University of Utah
Salt Lake City, Utah, United States, 84113
Actively Recruiting
14
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
15
Queensland Children's Hospital
Brisbane, Australia, 4101
Actively Recruiting
16
Royal Children's Hospital
Parkville, Australia, 3052
Actively Recruiting
17
Perth Children's Hospital
Perth, Australia, WA 6009
Actively Recruiting
18
Sydney Children's Hospital
Randwick, Australia, NSW 2031
Actively Recruiting
19
The Children's Hospital at Westmead
Westmead, Australia, 2145
Actively Recruiting
20
Centre Hospitalier Universitaire Ste-Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
21
Montreal Children's Hospital
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
22
Centre Mère-Enfant Soleil du CHU
Québec, Quebec, Canada, G1V 4G2
Actively Recruiting
23
Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
24
Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Otto-Heubner-Centrum für Kinder
Berlin, Germany, 13353
Actively Recruiting
25
Hopp-Kindertumorzentrum Heidelberg (KiTZ), KiTZ Clinical Trial Unit (ZIPO)
Heidelberg, Germany, 69120
Actively Recruiting
26
Rambam Health Care Campus
Haifa, Israel, 3109601
Actively Recruiting
27
Schneider Children's Medical Center of Israel
Petah Tikva, Israel, 4920235
Actively Recruiting
28
The Chaim Sheba Medical Center
Ramat Gan, Israel, 5265601
Actively Recruiting
29
Princess Maxima Center for Pediatric Oncology
Utrecht, Netherlands, 3584 CS
Actively Recruiting
30
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Actively Recruiting
31
Seoul National University Hospital
Seoul, South Korea, 3080
Actively Recruiting
32
Severance Hospital - Yonsei University
Seoul, South Korea, 3722
Actively Recruiting
33
Universitäts-Kinderspital Zürich - Eleonorenstiftung
Zurich, Switzerland, 8032
Actively Recruiting
34
UCL Great Ormond Street Institute of Child Health
London, United Kingdom, WC1N 1EH
Actively Recruiting
35
Newcastle University
Newcastle upon Tyne, United Kingdom, NE1 7RU
Actively Recruiting
Research Team
D
Day One Biopharmaceuticals, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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