5 recruiting, 3 completed, 3 terminated, 2 active not recruiting. 7 Phase 1, 6 Phase 2, 1 Early Phase 1, 1 Phase 3.
Follow tovorafenib: new trials by email Literature Review of tovorafenib trials Research Report on tovorafenib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study of Tovorafenib in High-Grade Glioma and Diffuse Intrinsic Pontine Glioma (DIPG) Tovorafenib - High Grade Glioma (HGG) of the Brain With BRAF Aberration, High Grade Glioma (III or IV) | Phase 2 | Not yet recruiting | Nationwide Children's Hospital | 79 | 2027-02-01 | 2026-10-20 |
| Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy - Hairy Cell Leukemia, Recurrent Hairy Cell Leukemia | Phase 1 / Phase 2 | Recruiting | National Cancer Institute (NCI) | 84 | 2026-05-29 | 2026-07-31 |
| A Study to Assess a Medicine Called Tovorafenib in Japanese Children and Young Adults With Brain Tumours Tovorafenib - Low-grade Glioma | Phase 1 | Active not recruiting | Ipsen | 6 | 2026-03-10 | 2026-10-01 |
| A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy - Recurrent Langerhans Cell Histiocytosis, Refractory Langerhans Cell Histiocytosis | Phase 2 | Recruiting | National Cancer Institute (NCI) | 48 | 2024-03-28 | 2026-10-30 |
| Pilot Study of Vinblastine and Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas Tovorafenib, Vinblastine - Low-grade Glioma | Early Phase 1 | Recruiting | Daniel Morgenstern | 57 | 2024-03-21 | 2025-05-15 |
| DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2) Tovorafenib, Chemotherapeutic Agent - Low-grade Glioma, Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma | Phase 3 | Active not recruiting | Day One Biopharmaceuticals, Inc. | 418 | 2023-02-27 | 2026-10-19 |
| Tovorafenib for Treatment of Craniopharyngioma in Children and Young Adults Tovorafenib - Craniopharyngioma, Child, Craniopharyngioma | Phase 2 | Recruiting | Sabine Mueller, MD, PhD | 57 | 2022-09-12 | 2026-04-23 |
| Tovorafenib (DAY101) or in Combination With Pimasertib for Participants With Melanoma and Other Solid Tumors Tovorafenib, Tovorafenib Drug: Pimasertib - Melanoma, Solid Tumor | Phase 1 | Terminated | Day One Biopharmaceuticals, Inc. | 44 | 2022-05-02 | 2025-08-14 |
| Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors Tovorafenib - Melanoma, Solid Tumor | Phase 2 | Terminated | Day One Biopharmaceuticals, Inc. | 23 | 2021-07-15 | 2025-10-02 |
| A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors Tovorafenib - Low-grade Glioma, Advanced Solid Tumor | Phase 2 | Recruiting | Day One Biopharmaceuticals, Inc. | 141 | 2021-04-22 | 2025-04-10 |
| DAY101 In Gliomas and Other Tumors DAY101 - Low-grade Glioma | Phase 1 | Completed | Karen D. Wright, MD | 44 | 2018-02-27 | 2026-02-19 |
| Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma TAK-580, TAK-202, vedolizumab - Melanoma | Phase 1 | Terminated | Millennium Pharmaceuticals, Inc. | 22 | 2016-06-22 | 2024-03-05 |
| A Study MLN2480 in Combination With MLN0128 or Alisertib, or Paclitaxel, or Cetuximab, or Irinotecan in Adult Participants With Advanced Nonhematologic Malignancies MLN2480, MLN0128, Alisertib - Advanced Nonhematologic Malignancies | Phase 1 | Completed | Millennium Pharmaceuticals, Inc. | 81 | 2015-01-14 | 2020-02-25 |
| Study of MLN2480 in Participants With Relapsed or Refractory Solid Tumors Followed by a Dose Expansion in Participants With Metastatic Melanoma MLN2480 - Melanoma, Metastatic Melanoma | Phase 1 | Completed | Millennium Pharmaceuticals, Inc. | 149 | 2011-09-15 | 2020-08-10 |
| Expanded Access Program (EAP) for Tovorafenib (DAY101) in RAF-Altered, Relapsed or Refractory Low-Grade Glioma Tovorafenib - Low-grade Glioma | Approved for marketing | Day One Biopharmaceuticals, Inc. | 2024-08-12 |
Melanoma (4) · Astrocytoma (2) · Carcinoma, Non-Small-Cell Lung (2) · Colorectal Neoplasms (2) · Glioma (2) · Neoplasms (2) · Pancreatic Neoplasms (2) · Brain Neoplasms (1) · Craniopharyngioma (1) · Diffuse Intrinsic Pontine Glioma (1) · Histiocytosis, Langerhans-Cell (1) · Leukemia, Hairy Cell (1) · Noonan Syndrome 5 (1) · Thyroid Cancer, Papillary (1) · Urinary Bladder Neoplasms (1)
Day One Biopharmaceuticals, Inc. (5) · Millennium Pharmaceuticals, Inc. (3) · National Cancer Institute (NCI) (2) · Daniel Morgenstern (1) · Ipsen (1) · Karen D. Wright, MD (1) · Nationwide Children's Hospital (1) · Sabine Mueller, MD, PhD (1)
United States (11) · Canada (6) · Australia (5) · United Kingdom (4) · France (3) · South Korea (3) · Spain (3) · Belgium (2) · Denmark (2) · Germany (2) · Israel (2) · Netherlands (2) · Singapore (2) · Switzerland (2) · Austria (1)
Carl E Allen (1) · Cassie Kline, MD (1) · Daniel Morgenstern (1) · Karen D. Wright, MD (1) · Sabine Mueller, MD, PhD, MAS (1) · Seema A Bhat (1)
PMID 37219686, PMID 37978284, PMID 38291372, PMID 41198344, PMID 42826365
2014 (1), 2015 (1), P50CA165962 (1), U10CA180886 (1), UM1CA186712 (1)