Tovorafenib (DAY101) or in Combination With Pimasertib for Participants With Melanoma and Other Solid Tumors
NCT07121829 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2025-08-14
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
- DRUG
-
Tovorafenib
Tovorafenib tablet for oral use.
- DRUG
-
Tovorafenib Drug: Pimasertib
Tovorafenib tablet for oral use. Pimasertib capsule for oral use
Sponsors & Collaborators
-
Day One Biopharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-02
- Primary Completion
- 2024-12-18
- Completion
- 2024-12-18
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
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