Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors
Purpose
This is a Phase 2, multi-center, open-label to evaluate the efficacy and safety of tovorafenib (DAY101) in participants ≥12 years of age with recurrent or progressive melanoma or solid tumors with BRAF fusion or CRAF/RAF1 fusions or amplification.
Conditions
- Melanoma
- Solid Tumor
- CRAF Gene Amplification
- RAF1 Gene Amplification
- BRAF Gene Fusion
- BRAF Fusion
- CRAF Gene Fusion
- CRAF Fusion
- RAF1 Gene Fusion
- RAF1 Fusion
- Thyroid Cancer, Papillary
- Spitzoid Melanoma
- Pilocytic Astrocytoma
- Pilocytic Astrocytoma, Adult
- Non Small Cell Lung Cancer
- Non-Small Cell Adenocarcinoma
- Colorectal Cancer
- Pancreatic Acinar Carcinoma
- Spitzoid Malignant Melanoma
- Bladder Cancer
- Bladder Urothelial Carcinoma
- MAP Kinase Family Gene Mutation
- RAF Mutation
Eligibility
- Eligible Ages
- Over 12 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Signed informed consent by participants ≥ 12 years of age either a Consent or an Assent Form will be provided to the patient based on their capacity, local regulations, and guidelines. - Participants must have a histologically confirmed diagnosis of melanoma or other solid tumor and a BRAF fusion, CRAF/RAF1 fusion, or CRAF/RAF1 amplifications obtained through a tumor or liquid biopsy as assessed by genomic sequencing, polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or another clinically accepted molecular diagnostic method recognized by local laboratory or regulatory agency. - Participants must have radiographically-recurrent or radiographically-progressive disease that is measurable using the appropriate tumor response criteria (e.g. RECIST version 1.1 or RANO). - Archival tumor tissue (preferably less than 3 years old) or fresh tumor tissue for correlative studies is required - If brain metastases are present, they must have been previously treated and be stable as assessed by radiographic imaging
Exclusion Criteria
- Prior therapy of any RAS-, RAF-, MEK-, or ERK-directed inhibitor therapy - Known presence of concurrent activating mutation - Participants with current evidence or a history of central serous retinopathy (CSR), retinal vein occlusion (RVO)
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Melanoma Cohort |
Tovorafenib monotherapy |
|
|
Experimental Tissue Agnostic Cohort |
Tovorafenib monotherapy |
|
More Details
- Status
- Terminated
- Sponsor
- Day One Biopharmaceuticals, Inc.