Trials / Terminated
TerminatedNCT07121829
Tovorafenib (DAY101) or in Combination With Pimasertib for Participants With Melanoma and Other Solid Tumors
A Phase 1b/2, Subprotocol of DAY101 in Combination With Pimasertib for Patients With Recurrent, Progressive, or Refractory Solid Tumors and MAPK Pathway Aberrations
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Day One Biopharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This is a subprotocol of Master Protocol DAY101-102 and is a Phase 1b/2, multi-center, open label subprotocol of participants ≥12 years of age, with recurrent or progressive solid tumors with alterations in the key proteins of the MAPK pathway, such as tumors that harbor RAS or RAF alterations. \*Note: Study concluded as Phase 1b only.
Conditions
- Melanoma
- Solid Tumor
- Pilocytic Astrocytoma
- Non Small Cell Lung Cancer
- Colorectal Cancer
- Pancreatic Cancer
- MAP Kinase Family Gene Mutation
- RAS Mutation
- RAF Mutation
- MEK Mutation
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tovorafenib | Tovorafenib tablet for oral use. |
| DRUG | Tovorafenib Drug: Pimasertib | Tovorafenib tablet for oral use. Pimasertib capsule for oral use |
Timeline
- Start date
- 2022-05-02
- Primary completion
- 2024-12-18
- Completion
- 2024-12-18
- First posted
- 2025-08-14
- Last updated
- 2025-08-14
Locations
10 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07121829. Inclusion in this directory is not an endorsement.