NCT04775485Recruiting
A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors
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 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.
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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Countries
- Switzerland, Germany, United States, Australia, Canada, Denmark, Israel, Netherlands, Singapore, South Korea, United Kingdom
- Sponsor
- Day One Biopharmaceuticals, Inc.(Industry)
- Protocol no.
- DAY101-001/PNOC026
- Conditions
- Low-grade Glioma, Advanced Solid Tumor
- Interventions
- Drug
Treatments studied
- Tovorafenib
Collaborators
Pacific Pediatric Neuro-Oncology Consortium
Locations · 33
- Zurich, SwitzerlandUniversitäts-Kinderspital Zürich - EleonorenstiftungRecruiting at this site
- Berlin, GermanyCharité Universitätsmedizin Berlin, Campus Virchow Klinikum, Otto-Heubner-Centrum für KinderRecruiting at this site
- Heidelberg, GermanyHopp-Kindertumorzentrum Heidelberg (KiTZ), KiTZ Clinical Trial Unit (ZIPO)Recruiting at this site
- San Francisco, United StatesUCSF Benioff Children's HospitalRecruiting at this site
- Washington D.C., United StatesChildren's National Medical CenterRecruiting at this site
- Chicago, United StatesLurie Children's Hospital of ChicagoRecruiting at this site
- Boston, United StatesDana-Farber Cancer InstituteRecruiting at this site
- Ann Arbor, United StatesCS Mott Children's HospitalRecruiting at this site
- St Louis, United StatesSt. Louis Children's HospitalRecruiting at this site
- New York, United StatesNYU Langone HealthRecruiting at this site
- Durham, United StatesDuke Cancer CenterRecruiting at this site
- Philadelphia, United StatesChildren's Hospital of PhiladelphiaRecruiting at this site
- Houston, United StatesTexas Children's HospitalRecruiting at this site
- Salt Lake City, United StatesUniversity of UtahRecruiting at this site
- Seattle, United StatesSeattle Children's HospitalRecruiting at this site
- Brisbane, AustraliaQueensland Children's HospitalRecruiting at this site
- Parkville, AustraliaRoyal Children's HospitalRecruiting at this site
- Perth, AustraliaPerth Children's HospitalRecruiting at this site
- Randwick, AustraliaSydney Children's HospitalRecruiting at this site
- Westmead, AustraliaThe Children's Hospital at WestmeadRecruiting at this site
- Montreal, CanadaCentre Hospitalier Universitaire Ste-JustineRecruiting at this site
- Montreal, CanadaMontreal Children's HospitalRecruiting at this site
- Québec, CanadaCentre Mère-Enfant Soleil du CHURecruiting at this site
- Copenhagen, DenmarkRigshospitaletRecruiting at this site
- Haifa, IsraelRambam Health Care CampusRecruiting at this site
- Petah Tikva, IsraelSchneider Children's Medical Center of IsraelRecruiting at this site
- Ramat Gan, IsraelThe Chaim Sheba Medical CenterRecruiting at this site
- Utrecht, NetherlandsPrincess Maxima Center for Pediatric OncologyRecruiting at this site
- Singapore, SingaporeKK Women's and Children's HospitalRecruiting at this site
- Seoul, South KoreaSeoul National University HospitalRecruiting at this site
In total, worldwide, 33 of the 35 sites listed in the registry are recruiting; the other 2 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: April 10, 2025).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 3 more locations
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.