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

Stopped early · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT04985604

Run by

Day One Biopharmaceuticals, Inc.

People needed

23

Starts

2021-07-15

Expected to finish

2024-07-08

Last updated by the study team

2025-10-02

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• The Angeles Clinic — Los Angeles, California, United States
• Hoag Health — Newport Beach, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Cancer Specialists of North Florida — Jacksonville, Florida, United States
• Community North Cancer Center — Indianapolis, Indiana, United States
• OHSU Knight Cancer Institute — Portland, Oregon, United States
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• Monash Medical Centre — Clayton, Victoria, Australia
• Antwerp University Hospital — Edegem, Belgium
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• The Hospital for Sick Children — Toronto, Ontario, Canada
• Hopital de La Timone - APHM — Marseille, Bouches-du-Rhône, France
• Dong-A University Hospital — Busan, South Korea
• Asan Medical Center — Seoul, South Korea
• Samsung Medical Center — Seoul, South Korea
• Severance Hospital, Yonsei University Health System — Seoul, South Korea
• Hospital Clinic Barcelona — Barcelona, Spain
• Hospital Universitari Vall d'Hebron — Barcelona, Spain
• Hospital Universitario Ramón y Cajal — Madrid, Spain

Full record on ClinicalTrials.gov

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