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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedTovorafenib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · BRAF · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 2, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?20 U.S. locations

Locations may change over time.

Who runs it?Day One Biopharmaceuticals, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Day One Biopharmaceuticals, Inc.
Interventions being studied: Drug: Tovorafenib

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Recurrent or relapsed→

Biomarkers

BRAF→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

The Angeles ClinicLos Angeles, California
Hoag HealthNewport Beach, California
University of Colorado HospitalAurora, Colorado
Cancer Specialists of North FloridaJacksonville, Florida
Community North Cancer CenterIndianapolis, Indiana
OHSU Knight Cancer InstitutePortland, Oregon
UPMC Hillman Cancer CenterPittsburgh, Pennsylvania
Vanderbilt-Ingram Cancer CenterNashville, Tennessee
Monash Medical CentreClayton, Victoria
Antwerp University HospitalEdegem
Princess Margaret Cancer CentreToronto, Ontario
The Hospital for Sick ChildrenToronto, Ontario

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 2, 2025. Always confirm current availability with the study team.

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