Program Status
Active, not recruitingPhase
Phase 1 Phase 2Prior Immunotherapy Allowed
YesCRC-directed Trial
NoDrugs
DCC-3014Tags
MSS/ MMRpComments
Study of DCC-3014 (anti-CSF1R) in Patients With Advanced Malignancies
Location | Location Status |
---|---|
United States | |
Stanford Cancer Institute Palo Alto, California 94304 |
Active, not recruiting |
University of Colorado - Denver Denver, Colorado 80204 |
Active, not recruiting |
Mayo Clinic Jacksonville, Florida 32224 |
Active, not recruiting |
University of Miami Miami, Florida 33136 |
Active, not recruiting |
Dana Farber Boston, Massachusetts 02215 |
Active, not recruiting |
MSKCC New York, New York 10065 |
Active, not recruiting |
OHSU Portland, Oregon 97239 |
Active, not recruiting |
Oregon Health & Science University Portland, Oregon 97239 |
Active, not recruiting |
Sarah Cannon Research Institute Nashville, Tennessee 37203 |
Active, not recruiting |
Australia | |
Peter MacCallum Cancer Centre Melbourne |
Active, not recruiting |
Canada | |
McGill University Health Centre Montréal, Quebec |
Active, not recruiting |
Princess Margaret Cancer Center Toronto |
Active, not recruiting |
France | |
Centre Leon Berard Lyon |
Active, not recruiting |
Gustave Roussy Cancer Campus Grand Paris Paris |
Active, not recruiting |
Italy | |
IRCCS Istituto Ortopedico Rizzoli Bologna |
Active, not recruiting |
Fondazione IRCCS Istituto Nazionale Dei Tumori Milan |
Active, not recruiting |
Istituto Nazionale dei Tumori Milan |
Active, not recruiting |
Regina Elena National Cancer Institute Rome |
Active, not recruiting |
Netherlands | |
Leiden University Medical Center Leiden |
Active, not recruiting |
Poland | |
M. Sklodowska-Curie Memorial Cancer Center Warsaw |
Active, not recruiting |
Spain | |
Hospital Universitario Vall d'Hebron Barcelona |
Active, not recruiting |
Hospital Clinico San Carlos Madrid |
Active, not recruiting |
Hospital Universitario Virgen del Rocío, Sevilla Sevilla |
Active, not recruiting |
United Kingdom | |
University College Hospital London |
Active, not recruiting |
Inclusion Criteria
Inclusion Criteria
Dose Escalation Phase:
1. Patients ≥18 years of age
2. Patients must have:
1. advanced malignant solid tumors; or
2. symptomatic TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening)
3. Malignant solid tumor patients only: Able to provide a tumor tissue sample
4. Must have 1 measurable lesion according to RECIST Version 1.1
5. Malignant solid tumor patients only: Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
6. Adequate organ and bone marrow function
7. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements.
8. Must provide signed consent to participate in the study and is willing to comply with study-specific procedures.
Expansion Phase (Cohorts A and B)
1. Patients ≥18 years of age
2. 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
3. Adequate organ and bone marrow function
4. Must have at least 1 measurable lesion according to RECIST Version 1.1
5. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements.
6. Must provide signed consent to participate in the study and is willing to comply with study-specific procedures.
Exclusion Criteria
Exclusion Criteria
Dose Escalation Phase:
1. 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.
2. Unresolved toxicity (Grade >1 or baseline) from previous anticancer therapy or TGCT therapy, excluding alopecia.
3. Known active central nervous system (CNS) metastases.
4. History or presence of clinically relevant cardiovascular abnormalities.
5. Systemic arterial or venous thrombotic or embolic events.
6. QT interval corrected by Fridericia's formula (QTcF) >450 ms in males or >470 ms in females or history of long QT syndrome.
7. Left ventricular ejection fraction (LVEF)