Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Advanced Malignant Neoplasm, Pigmented Villonodular Synovitis, Giant Cell Tumor of Tendon Sheath, Tenosynovial Giant Cell Tumor, Tenosynovial Giant Cell Tumor, Diffuse

In brief

This is a multicenter, open-label Phase 1/2 study of vimseltinib in patients with malignant solid tumors and tenosynovial giant cell tumor (TGCT). There will be 2 distinct parts in this study: Dose Escalation (Phase 1) and Expansion (Phase 2). Phase 1 will enroll both malignant solid tumor and TGCT patients. Phase 2 will comprise two cohorts (Cohort A and Cohort B) and will only enroll TGCT patients.

Key facts

Study ID

NCT03069469

Run by

Deciphera Pharmaceuticals, LLC

People needed

120

Starts

2017-02-16

Expected to finish

2028-08-01

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Dose Escalation Phase:
• Patients ≥18 years of age
• Patients must have:
• advanced malignant solid tumors; or
• symptomatic TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening)
• Malignant solid tumor patients only: Able to provide a tumor tissue sample
• Must have 1 measurable lesion according to RECIST Version 1.1
• Malignant solid tumor patients only: Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Adequate organ and bone marrow function
• If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements.
• Must provide signed consent to participate in the study and is willing to comply with study-specific procedures.
• Expansion Phase (Cohorts A and B)
• Patients ≥18 years of age
• Patients must have symptomatic TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening)
• a) Expansion Cohort B: patients must have prior systemic treatment with anti-CSF1 or anti-CSF1R therapy, with the exception of imatinib or nilotinib
• Adequate organ and bone marrow function
• Must have at least 1 measurable lesion according to RECIST Version 1.1
• If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements.
• Must provide signed consent to participate in the study and is willing to comply with study-specific procedures.

You may not qualify if…

• Dose Escalation Phase:
• Received anticancer therapy or therapy for TGCT, including investigational therapy, within 2 weeks or 28 days for therapies with half-life (t1/2) longer than 3 days prior to the administration of study drug.
• Unresolved toxicity (Grade >1 or baseline) from previous anticancer therapy or TGCT therapy, excluding alopecia.
• Known active central nervous system (CNS) metastases.
• History or presence of clinically relevant cardiovascular abnormalities.
• Systemic arterial or venous thrombotic or embolic events.
• QT interval corrected by Fridericia's formula (QTcF) >450 ms in males or >470 ms in females or history of long QT syndrome.
• Left ventricular ejection fraction (LVEF) <50%.
• Concurrent treatment with proton-pump inhibitor(s).
• Major surgery within 2 weeks of the first dose of study drug.
• Malabsorption syndrome or other illness that could affect oral absorption.
• Known human immunodeficiency virus, active hepatitis B, active hepatitis C, or active mycobacterium tuberculosis infection.
• If female, the patient is pregnant or lactating.
• Known allergy or hypersensitivity to any component of the study drug.
• Any other clinically significant comorbidities.
• Expansion Phase (Cohorts A and B)
• Expansion Cohort A: received systemic therapy targeting CSF1 or CSF1R; previous therapy with imatinib and nilotinib is allowed.
• Expansion Cohort B: discontinued systemic therapy targeting anti-CSF1 or anti-CSF1R due to drug-induced liver injury.
• Treatment with therapy for TGCT, including investigational therapy, within 2 weeks or 28 days for therapies with a t1/2 longer than 3 days prior to the administration of the study drug.
• Known metastatic TGCT or other active cancer that requires concurrent treatment.
• QT interval corrected by Fridericia's formula (QTcF) >450 ms in males or >470 ms in females or history of long QT syndrome.
• Left ventricular ejection fraction (LVEF) <55%.
• Concurrent treatment with proton-pump inhibitor(s).
• Major surgery within 2 weeks of the first dose of study drug.
• Any clinically significant comorbidities

Where it is running

• Stanford Cancer Institute — Palo Alto, California, United States
• University of Colorado - Denver — Denver, Colorado, United States
• Mayo Clinic — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Dana Farber — Boston, Massachusetts, United States
• MSKCC — New York, New York, United States
• OHSU — Portland, Oregon, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Peter MacCallum Cancer Centre — Melbourne, Australia
• McGill University Health Centre — Montreal, Quebec, Canada
• Princess Margaret Cancer Center — Toronto, Canada
• Centre Leon Berard — Lyon, France
• Gustave Roussy Cancer Campus Grand Paris — Paris, France
• IRCCS Istituto Ortopedico Rizzoli — Bologna, Italy
• Fondazione IRCCS Istituto Nazionale Dei Tumori — Milan, Italy
• Istituto Nazionale dei Tumori — Milan, Italy
• Regina Elena National Cancer Institute — Rome, Italy
• Leiden University Medical Center — Leiden, Netherlands
• M. Sklodowska-Curie Memorial Cancer Center — Warsaw, Poland
• Hospital Universitario Vall d'Hebron — Barcelona, Spain
• Hospital Clinico San Carlos — Madrid, Spain
• Hospital Universitario Virgen del Rocío, Sevilla — Seville, Spain
• University College Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.