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

Program Status

Active, not recruiting

Phase

Phase 1 Phase 2

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

No

Drugs

DCC-3014

Tags

MSS/ MMRp

Comments

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)

NCT ID

NCT03069469

Date Trial Added

2017-03-03

Updated Date

2024-11-20