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

Part of paid clinical trials in San Francisco, California.

Sponsor
Day One Biopharmaceuticals, Inc.
Study ID
NCT04775485
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Low-grade Glioma

Eligibility Criteria

Sex
ALL
Age
6 Months - 25 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 22, 2021
Status verified
Mar 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
141 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Arm 1: Overall response rate [ Time Frame: Up to 48 months ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
UCSF Benioff Children's HospitalSan FranciscoCalifornia94143-
Children's National Medical CenterWashington D.C.District of Columbia20010
202-476-5000
Lurie Children's Hospital of ChicagoChicagoIllinois60611-
Johns Hopkins HospitalBaltimoreMaryland21231-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
CS Mott Children's HospitalAnn ArborMichigan48109-
St. Louis Children's HospitalSt LouisMissouri63110-
NYU Langone HealthNew YorkNew York10016-
Duke Cancer CenterDurhamNorth Carolina27710-
Doernbecher Children's Hospital Oregon & Health Science UniversityPortlandOregon97239-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Texas Children's HospitalHoustonTexas77030-
University of UtahSalt Lake CityUtah84113-
Seattle Children's HospitalSeattleWashington98105-

Find similar trials in San Francisco, CA

By research site
UCSF Benioff Children's Hospital· San Francisco, CAChildren's National Medical Center· Washington D.C., DCLurie Children's Hospital of Chicago· Chicago, ILJohns Hopkins Hospital· Baltimore, MDDana-Farber Cancer Institute· Boston, MACS Mott Children's Hospital· Ann Arbor, MI

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