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

NCT04985604 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-10-02

Study results available
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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.

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

Interventions

DRUG

Tovorafenib

Tovorafenib tablet for oral use.

Sponsors & Collaborators

  • Day One Biopharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-15
Primary Completion
2024-07-08
Completion
2024-07-08
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04985604 on ClinicalTrials.gov