Tovorafenib

DRUG15 trials

Conditions

Advanced Solid TumorBRAF FusionBRAF Gene FusionBladder CancerBladder Urothelial CarcinomaCRAF FusionCRAF Gene AmplificationCRAF Gene Fusion

Early Phase 1

Pilot Study of Vinblastine and Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas

RecruitingNCT06381570

Daniel MorgensternLow-grade Glioma

Start: 2024-03-21End: 2029-03-21Target: 57Updated: 2025-05-15

Phase 1

Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia

RecruitingNCT06965114

National Cancer Institute (NCI)Hairy Cell Leukemia, Recurrent Hairy Cell Leukemia, Refractory Hairy Cell Leukemia

Start: 2026-06-27End: 2030-03-01Target: 84Updated: 2026-04-03

Tovorafenib (DAY101) or in Combination With Pimasertib for Participants With Melanoma and Other Solid Tumors

TerminatedNCT07121829

Day One Biopharmaceuticals, Inc.Colorectal Cancer, MAP Kinase Family Gene Mutation, MEK Mutation +7

Start: 2022-05-02End: 2024-12-18Updated: 2025-08-14

A Study to Assess a Medicine Called Tovorafenib in Japanese Children and Young Adults With Brain Tumours

Not yet recruitingNCT07441707

IpsenLow-grade Glioma

Start: 2026-02-16End: 2030-07-31Target: 6Updated: 2026-03-02

Phase I/II combination umbrella trial in progressive/relapsed/refractory pediatric low-grade glioma (pLGG) (EPILOGUE)

Not yet recruitingCTIS2024-516896-34-00

Universitaetsklinikum Heidelberg AöRprogressive/relapsed/refractory pediatric low-grade glioma (pLGG)

Target: 28Updated: 2026-03-18

Phase 2

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

RecruitingNCT04775485

Day One Biopharmaceuticals, Inc.Advanced Solid Tumor, Low-grade Glioma

Start: 2021-04-22End: 2027-05-31Target: 141Updated: 2025-04-10

Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors

TerminatedNCT04985604

Day One Biopharmaceuticals, Inc.Bladder Cancer, Bladder Urothelial Carcinoma, BRAF Fusion +20

Start: 2021-07-15End: 2024-07-08Updated: 2025-10-02

Tovorafenib for Treatment of Craniopharyngioma in Children and Young Adults

RecruitingNCT05465174

Sabine Mueller, MD, PhDCraniopharyngioma, Craniopharyngioma, Child, Recurrent Craniopharyngioma

Start: 2022-09-12End: 2028-03-01Target: 57Updated: 2026-03-09

A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis

RecruitingNCT05828069

National Cancer Institute (NCI)Recurrent Langerhans Cell Histiocytosis, Refractory Langerhans Cell Histiocytosis

Start: 2024-03-28End: 2028-09-30Target: 48Updated: 2026-04-03

FIREFLY-1: A Phase 2, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients with RAF-Altered, Recurrent or Progressive Low-Grade Glioma and Advanced Solid Tumors

RecruitingCTIS2024-510691-20-00

Day One Biopharmaceuticals Inc., Day One Biopharmaceuticals Inc.RAF-Altered, Recurrent or Progressive Low-Grade Glioma and Advanced Solid Tumors in pediatric patients

Start: 2021-09-23Target: 16Updated: 2025-07-21

Study of Tovorafenib in High-Grade Glioma and Diffuse Intrinsic Pontine Glioma (DIPG)

Not yet recruitingNCT07206849

Nationwide Children's HospitalDiffuse Intrinsic Pontine Glioma, High Grade Glioma, High Grade Glioma (HGG) of the Brain With BRAF Aberration +4

Start: 2026-03-01End: 2037-03-01Target: 79Updated: 2025-10-29

PNOC029_Tovorafenib for the treatment of newly diagnosed or recurrent craniopharyngioma in children and young adults

Not yet recruitingCTIS2024-511510-20-00

Prinses Maxima Centrum voor Kinderoncologie B.V.craniopharyngioma

Target: 5Updated: 2026-03-25

Phase 3

DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)

RecruitingNCT05566795

Day One Biopharmaceuticals, Inc.Low-grade Glioma, Pediatric Low-grade Glioma, Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma

Start: 2023-02-27End: 2031-06-01Target: 400Updated: 2026-03-02

LOGGIC/FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients with Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy

RecruitingCTIS2024-510742-13-00

Day One Biopharmaceuticals Inc.Pediatric low-grade glioma harboring an activating RAF alteration requiring first-line systemic therapy

Start: 2023-04-19Target: 245Updated: 2025-11-19

Unknown Phase

Expanded Access Program (EAP) for Tovorafenib (DAY101) in RAF-Altered, Relapsed or Refractory Low-Grade Glioma

NCT05760586

Day One Biopharmaceuticals, Inc.Low-grade Glioma

Updated: 2024-08-12

Neuro-Oncology2025-11-01

Growth recovery in patients with BRAF altered pediatric low-grade gliomas (LGG) after discontinuation of tovorafenib.

Journal of Clinical Oncology2025-05-28

Post hoc analysis of rashes reported in patients (pts) with BRAF -altered relapsed/refractory (r/r) pediatric low-grade glioma (pLGG) treated with the type II RAF inhibitor tovorafenib in FIREFLY-1.

Journal of Clinical Oncology2025-05-28

FDA Approval Summary: Tovorafenib for Relapsed or Refractory BRAF-Altered Pediatric Low-Grade Glioma

Clinical Cancer Research2025-01-1411 citations

Omnigene-Guttm ensures fecal microbiome stability in the pediatric population.

2024-12-06

CTNI-09. TYPE II RAF INHIBITOR TOVORAFENIB IN RELAPSED/REFRACTORY (R/R) PEDIATRIC LOW-GRADE GLIOMA (PLGG): RESULTS FROM PATIENTS ON A DRUG HOLIDAY (DH) IN THE PHASE 2 FIREFLY-1 TRIAL

Neuro-Oncology2024-11-01

NCOG-05. HEALTH-RELATED QUALITY OF LIFE (HRQOL) IN THE PHASE 2 FIREFLY-1 (PNOC026) TRIAL OF THE TYPE II RAF INHIBITOR TOVORAFENIB IN RELAPSED/REFRACTORY (R/R) PEDIATRIC LOW-GRADE GLIOMA (PLGG)

Neuro-Oncology2024-11-01

Anti–Programmed Death Ligand 1 Plus Targeted Therapy in Anaplastic Thyroid Carcinoma

JAMA Oncology2024-10-2446 citations

LGG-40. TYPE II RAF INHIBITOR TOVORAFENIB IN RELAPSED/REFRACTORY PEDIATRIC LOW-GRADE GLIOMA (PLGG): REVERSIBLE DECREASES IN GROWTH VELOCITY IN THE PHASE 2 FIREFLY-1 TRIAL

Neuro-Oncology2024-06-181 citations

Type II RAF inhibitor tovorafenib in relapsed/refractory pediatric low-grade glioma (pLGG): Reversible decreases in growth velocity in the phase 2 FIREFLY-1 trial.

Journal of Clinical Oncology2024-06-012 citations

Abstract 1972: Preclinical activity of the type II RAF inhibitor tovorafenib in tumor models harboring either a BRAF fusion or a NF1-LOF mutation

Cancer Research2024-03-222 citations

LOGGIC/FIREFLY-2: a phase 3, randomized trial of tovorafenib vs. chemotherapy in pediatric and young adult patients with newly diagnosed low-grade glioma harboring an activating RAF alteration

BMC Cancer2024-01-3048 citations

The type II RAF inhibitor tovorafenib in relapsed/refractory pediatric low-grade glioma: the phase 2 FIREFLY-1 trial.

2023-11-17102 citations

CTNI-37. CLINICAL ACTIVITY OF RAF INHIBITOR TOVORAFENIB ACCORDING TO PRIOR MAPK INHIBITOR TREATMENT IN THE REGISTRATIONAL PEDIATRIC LOW-GRADE GLIOMA ARM OF THE PHASE 2 FIREFLY-1 (PNOC026) STUDY

Neuro-Oncology2023-11-011 citations

CTNI-24. CLINICAL ACTIVITY AND SAFETY OF THE RAF INHIBITOR TOVORAFENIB IN PATIENTS WITH OPTIC PATHWAY GLIOMAS IN THE REGISTRATIONAL PEDIATRIC LOW-GRADE GLIOMA ARM OF THE PHASE 2 FIREFLY-1 (PNOC026) STUDY

Neuro-Oncology2023-11-011 citations

Clinical activity of pan-RAF inhibitor tovorafenib in the registrational pediatric low-grade glioma arm of the phase 2 FIREFLY-1 (PNOC026) study.

Journal of Clinical Oncology2023-06-0113 citations

LOGGIC/FIREFLY-2: A phase 3, randomized trial of tovorafenib vs. chemotherapy in pediatric and young adult patients with newly diagnosed low-grade glioma harboring an activating RAF alteration.

Journal of Clinical Oncology2023-06-014 citations

LGG-09. CLINICAL ACTIVITY OF PAN-RAF INHIBITOR TOVORAFENIB IN THE REGISTRATIONAL PEDIATRIC LOW-GRADE GLIOMA ARM OF THE PHASE 2 FIREFLY-1 (PNOC026) STUDY

Neuro-Oncology2023-06-012 citations

Phase 1 study of the pan-RAF inhibitor tovorafenib in patients with advanced solid tumors followed by dose expansion in patients with metastatic melanoma.

2023-05-2327 citations

CTNI-68. FIREFLY-1 (PNOC026): PHASE 2 STUDY OF PAN-RAF INHIBITOR TOVORAFENIB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH RAF-ALTERED RECURRENT OR PROGRESSIVE LOW-GRADE GLIOMA OR ADVANCED SOLID TUMORS

Neuro-Oncology2022-11-0113 citations

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