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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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 6 Months - 25 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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 Criteria:

  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04775485
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Day One Biopharmaceuticals, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry, Other
Overall Status Recruiting
Countries Australia, Canada, Denmark, Germany, Israel, Korea, Republic of, Netherlands, Singapore, Switzerland, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Low-grade Glioma, Advanced Solid Tumor
Arms & Interventions

Arms

Experimental: Arm 1: Low-Grade Glioma

Participants with recurrent or progressive low-grade glioma will receive 420 milligrams/meters square (mg/m^2) of tovorafenib weekly according to dose rounding guidelines and according to their baseline body surface area (BSA).

Experimental: Arm 2: Low-Grade Glioma Expanded Access

Participants with recurrent or progressive low-grade glioma will receive 420 mg/m^2 of tovorafenib weekly according to dose rounding guidelines and according to their baseline BSA.

Experimental: Arm 3: Advanced Solid Tumor

Participants with advanced solid tumors will receive 420 mg/m^2) of tovorafenib weekly according to dose rounding guidelines and according to their baseline BSA.

Interventions

Drug: - Tovorafenib

Tovorafenib is an oral Type II RAF kinase inhibitor available in 100 mg immediate-release tablet or 25 mg/milliliter (mL) powder for reconstitution.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UCSF Benioff Children's Hospital, San Francisco, California

Status

Recruiting

Address

UCSF Benioff Children's Hospital

San Francisco, California, 94143

Children's National Medical Center, Washington, District of Columbia

Status

Recruiting

Address

Children's National Medical Center

Washington, District of Columbia, 20010

Lurie Children's Hospital of Chicago, Chicago, Illinois

Status

Recruiting

Address

Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611

Johns Hopkins Hospital, Baltimore, Maryland

Status

Terminated

Address

Johns Hopkins Hospital

Baltimore, Maryland, 21231

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

CS Mott Children's Hospital, Ann Arbor, Michigan

Status

Recruiting

Address

CS Mott Children's Hospital

Ann Arbor, Michigan, 48109

St. Louis Children's Hospital, Saint Louis, Missouri

Status

Recruiting

Address

St. Louis Children's Hospital

Saint Louis, Missouri, 63110

NYU Langone Health, New York, New York

Status

Recruiting

Address

NYU Langone Health

New York, New York, 10016

Duke Cancer Center, Durham, North Carolina

Status

Recruiting

Address

Duke Cancer Center

Durham, North Carolina, 27710

Portland, Oregon

Status

Terminated

Address

Doernbecher Children's Hospital Oregon & Health Science University

Portland, Oregon, 97239

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Recruiting

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Texas Children's Hospital, Houston, Texas

Status

Recruiting

Address

Texas Children's Hospital

Houston, Texas, 77030

University of Utah, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah

Salt Lake City, Utah, 84113

Seattle Children's Hospital, Seattle, Washington

Status

Recruiting

Address

Seattle Children's Hospital

Seattle, Washington, 98105

International Sites

Queensland Children's Hospital, Brisbane, Australia

Status

Recruiting

Address

Queensland Children's Hospital

Brisbane, , 4101

Royal Children's Hospital, Parkville, Australia

Status

Recruiting

Address

Royal Children's Hospital

Parkville, , 3052

Perth Children's Hospital, Perth, Australia

Status

Recruiting

Address

Perth Children's Hospital

Perth, , WA 6009

Sydney Children's Hospital, Randwick, Australia

Status

Recruiting

Address

Sydney Children's Hospital

Randwick, , NSW 2031

The Children's Hospital at Westmead, Westmead, Australia

Status

Recruiting

Address

The Children's Hospital at Westmead

Westmead, , 2145

Montreal, Quebec, Canada

Status

Recruiting

Address

Centre Hospitalier Universitaire Ste-Justine

Montreal, Quebec, H3T 1C5

Montreal Children's Hospital, Montreal, Quebec, Canada

Status

Recruiting

Address

Montreal Children's Hospital

Montreal, Quebec, H4A 3J1

Centre Mère-Enfant Soleil du CHU, Québec, Quebec, Canada

Status

Recruiting

Address

Centre Mère-Enfant Soleil du CHU

Québec, Quebec, G1V 4G2

Rigshospitalet, Copenhagen, Denmark

Status

Recruiting

Address

Rigshospitalet

Copenhagen, ,

Berlin, Germany

Status

Recruiting

Address

Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Otto-Heubner-Centrum für Kinder

Berlin, , 13353

Heidelberg, Germany

Status

Recruiting

Address

Hopp-Kindertumorzentrum Heidelberg (KiTZ), KiTZ Clinical Trial Unit (ZIPO)

Heidelberg, , 69120

Rambam Health Care Campus, Haifa, Israel

Status

Recruiting

Address

Rambam Health Care Campus

Haifa, , 3109601

Petah Tikva, Israel

Status

Recruiting

Address

Schneider Children's Medical Center of Israel

Petah Tikva, , 4920235

The Chaim Sheba Medical Center, Ramat Gan, Israel

Status

Recruiting

Address

The Chaim Sheba Medical Center

Ramat Gan, , 5265601

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, , 3080

Severance Hospital - Yonsei University, Seoul, Korea, Republic of

Status

Recruiting

Address

Severance Hospital - Yonsei University

Seoul, , 3722

Utrecht, Netherlands

Status

Recruiting

Address

Princess Maxima Center for Pediatric Oncology

Utrecht, , 3584 CS

KK Women's and Children's Hospital, Singapore, Singapore

Status

Recruiting

Address

KK Women's and Children's Hospital

Singapore, , 229899

Zürich, Switzerland

Status

Recruiting

Address

Universitäts-Kinderspital Zürich - Eleonorenstiftung

Zürich, , 8032

London, United Kingdom

Status

Recruiting

Address

UCL Great Ormond Street Institute of Child Health

London, , WC1N 1EH

Newcastle University, Newcastle Upon Tyne, United Kingdom

Status

Recruiting

Address

Newcastle University

Newcastle Upon Tyne, , NE1 7RU

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