DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
Launched by DAY ONE BIOPHARMACEUTICALS, INC. · Oct 3, 2022
Trial Information
Current as of July 27, 2025
Recruiting
Keywords
ClinConnect Summary
The DAY101 vs. Standard of Care Chemotherapy trial is studying a new treatment for children and young adults with low-grade glioma (LGG), a type of brain tumor that is generally less aggressive. The trial compares a medication called tovorafenib, which targets specific changes in the tumor, to the standard chemotherapy currently used. This research is important because it aims to find out if tovorafenib is more effective and safe for treating this condition.
To participate in this trial, patients must be under 25 years old and have a specific kind of low-grade glioma that has a known change in a gene called RAF. They should have at least one measurable tumor and require first-line treatment. Patients with certain types of tumors or other specific conditions will not be eligible. Those who join can expect to receive either the new medication or standard chemotherapy and will be closely monitored for safety and how well the treatment works. This trial is actively recruiting participants, and it is an opportunity to potentially access a new therapy while helping advance medical knowledge.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Less than 25 years of age with LGG with known activating RAF alteration.
- • Histopathologic diagnosis of glioma or glioneuronal tumor.
- • At least one measurable lesion as defined by RANO criteria.
- • Meet indication for first-line systemic therapy.
- Exclusion Criteria:
- * Participant has any of the following tumor-histological findings:
- • 1. Schwannoma
- • 2. Subependymal giant cell astrocytoma (Tuberous Sclerosis)
- • 3. Diffuse intrinsic pontine glioma, even if histologically diagnosed as World Health Organization (WHO) Grade I-II
- • Participant's tumor has additional pathogenic molecular alterations, including but not limited to a) isocitrate dehydrogenase (IDH) 1/2 mutation, b) Histone H3 mutation, and c) neurofibromatosis Type 1 (NF-1) loss of function alteration.
- • Known or suspected diagnosis of NF-1/ neurofibromatosis Type 2 (NF-2).
- • Prior or ongoing nonsurgical anticancer therapy for this indication (eg, chemotherapy, oral/IV targeted therapy) including radiation.
About Day One Biopharmaceuticals, Inc.
Day One Biopharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for patients with cancer, particularly focusing on targeted treatments for pediatric populations. With a commitment to advancing precision medicine, Day One leverages cutting-edge research and development to address unmet medical needs in oncology. The company aims to transform the treatment landscape by delivering novel, effective, and safe therapeutic options, while fostering collaboration within the scientific community to enhance patient outcomes and improve quality of life.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ottawa, Ontario, Canada
Copenhagen, , Denmark
Scarborough, Maine, United States
Saint Louis, Missouri, United States
Calgary, Alberta, Canada
Phoenix, Arizona, United States
Madrid, , Spain
Boston, Massachusetts, United States
Los Angeles, California, United States
Rochester, New York, United States
Houston, Texas, United States
Washington, District Of Columbia, United States
Dallas, Texas, United States
Aurora, Colorado, United States
Seattle, Washington, United States
Orlando, Florida, United States
Hamburg, , Germany
Chicago, Illinois, United States
Atlanta, Georgia, United States
Sevilla, , Spain
Lyon, , France
Heidelberg, , Germany
Marseille, , France
Villejuif, , France
Tübingen, , Germany
Freiburg, Baden Württemberg, Germany
Erlangen, Bayern, Germany
Hannover, Niedersachsen, Germany
Madison, Wisconsin, United States
Edmonton, Alberta, Canada
Seoul, , Korea, Republic Of
Freiburg, , Germany
Barcelona, , Spain
Paris, , France
Lausanne, , Switzerland
Vancouver, British Columbia, Canada
Sheffield, South Yorkshire, United Kingdom
Taipei, , Taiwan
Berlin, , Germany
Petah Tikva, , Israel
Seoul, , Korea, Republic Of
Sutton, Surrey, United Kingdom
Cambridge, , United Kingdom
Cleveland, Ohio, United States
Wien, , Austria
Genova, , Italy
Würzburg, Bayern, Germany
Tampere, , Finland
Taoyuan, , Taiwan
Valencia, , Spain
Lille, , France
Ghent, , Belgium
Madrid, , Spain
Birmingham, Alabama, United States
Brussel, , Belgium
Frankfurt, Hessen, Germany
Gainesville, Florida, United States
Southampton, Hampshire, United Kingdom
Minneapolis, Minnesota, United States
Indianapolis, Indiana, United States
Leipzig, Sachsen, Germany
Innsbruck, Tirol, Austria
Durham, North Carolina, United States
South Brisbane, Queensland, Australia
Seoul, Jongno Gu, Korea, Republic Of
San Francisco, California, United States
Essen, Nordrhein Westfalen, Germany
Westmead, , Australia
Barakaldo, , Spain
New York, New York, United States
Hartford, Connecticut, United States
Birmingham, England, United Kingdom
Glasgow, Scotland, United Kingdom
Leuven, , Belgium
Montréal, Quebec, Canada
Nedlands, , Australia
Aarhus, Midtjylland, Denmark
Orange, California, United States
Bari, , Italy
Lausanne, , Switzerland
Padova, , Italy
Utrecht, , Netherlands
Crumlin, Dublin, Ireland
Barcelona, , Spain
Montréal, Quebec, Canada
Ann Arbor, Michigan, United States
Prague, , Czechia
North Adelaide, , Australia
Randwick, , Australia
Québec, , Canada
Bielefeld, , Germany
Ulm, , Germany
Athens, , Greece
Grafton, , New Zealand
Ljubljana, , Slovenia
Stockholm, , Sweden
Zurich, , Switzerland
Augsburg, Bayern, Germany
Athens, , Greece
Budapest, , Hungary
Singapore, , Singapore
Parkville, , Australia
Innsbruck, , Austria
Brno, , Czechia
Toronto, , Canada
Helsinki, , Finland
Napoli, , Italy
Göteborg, , Sweden
Lund, , Sweden
Ramat Gan, , Israel
Oslo, , Norway
Bristol, , United Kingdom
Roma, Rome, Italy
Milano, Milan, Italy
Torino, Turin, Italy
Newcastle Upon Tyne, England, United Kingdom
Tromsø, Troms, Norway
Oxford, England, United Kingdom
Leeds, England, United Kingdom
Udine, , Italy
Manchester, England, United Kingdom
Liverpool, England, United Kingdom
Belfast, Northern Ireland, United Kingdom
Omaha, Nebraska, United States
Hamilton, Ontario, Canada
St. Petersburg, Florida, United States
Amman, Muhafazat Al Asima, Jordan
São Paulo, , Brazil
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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