TerminatedPhase 2NCT04985604

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

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.

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

StatusTerminated
PhasePhase 2
U.S. locations20
SponsorDay One Biopharmaceuticals, Inc.
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

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)

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

04
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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