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

Day One Biopharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: BRAF Fusion; CRAF Gene Fusion; Solid Tumor; Thyroid Cancer, Papillary; Non-Small Cell Adenocarcinoma; Melanoma; CRAF Fusion; RAF1 Fusion; CRAF Gene Amplification; Pilocytic Astrocytoma; MAP Kinase Family Gene Mutation; Spitzoid Melanoma; BRAF Gene Fusion; Bladder Urothelial Carcinoma; Non Small Cell Lung Cancer; Pilocytic Astrocytoma, Adult; Bladder Cancer; RAF1 Gene Amplification; Spitzoid Malignant Melanoma; RAF Mutation; RAF1 Gene Fusion; Pancreatic Acinar Carcinoma; Colorectal Cancer

Treatments: Drug: Tovorafenib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04985604

2021-003768-29 (EudraCT Number)

DAY101-102a

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Melanoma Cohort

Experimental group

Description:

Tovorafenib monotherapy

Treatment:

Drug: Tovorafenib

Tissue Agnostic Cohort

Experimental group

Description:

Tovorafenib monotherapy

Treatment:

Drug: Tovorafenib