This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of cabiralizumab in PVNS/dt-TGCT patients.
A Phase 1/2 study was an open-label, dose escalation and dose expansion study designed to evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary efficacy of cabiralizumab, a CSF1-R monoclonal antibody, inpatients with unresectable diffuse tenosynovial giant cell tumors (TGCT).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
FPA008 will be administered by IV infusion over approximately 30 minutes every 2 or 4 weeks
Cedars-Sinai Medical Center
Los Angeles, California, United States
Sarcoma Oncology Research Center LLC
Santa Monica, California, United States
Stanford Medicine
Stanford, California, United States
The Incidence of Grade 3 and Grade 4 Adverse Events (AEs) and Defined as Dose-limiting Toxicities (DLTs) in Phase 1
Number of participants with grade 3 and grade 4 adverse events (AE) defined as dose limiting toxicities (DLTs) in Phase 1
Time frame: 52 weeks
The Incidence of Investigator-assessed, Confirmed Objective Responses (ORR) Per RECIST 1.1 (Phase 2)
Number of confirmed objective responses (ORR) as assessed by the investigator per RECIST 1.1 (Phase 2)
Time frame: 52 weeks
PK Parameters of Cabiralizumab: Area Under Concentration-time Curve (AUC)
Area under serum concentration-time curve (AUC) for cabiralizumab as a PK parameter
Time frame: 52 weeks
Maximum Serum Concentration (Cmax).
Composite PK parameters of cabiralizumab: Maximum observed serum concentration
Time frame: 52 weeks
Minimum Serum Concentration (Cmin).
Composite PK parameters of cabiralizumab: minimum serum concentration (Cmin).
Time frame: 52 weeks
Pharmacokinetic Clearance (CL).
Composite PK parameters of cabiralizumab: clearance (CL)
Time frame: 52 weeks
The Incidence of AEs.
treatment-emergent adverse events (TEAEs) by incidence for the Safety Population. Patients with at lease 1 TEAE.
Time frame: 52 weeks
The Incidence of Clinical Laboratory Abnormalities.
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Institut Bergonie- CRLCC de Bordeaux et du Sud-Ouest
Bordeaux, France
Centre Léon Bérard
Lyon, France
Leiden University Medical Center
Leiden, Netherlands
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow, Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie
Warsaw, Poland
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
...and 2 more locations
The number of patients with a clinical laboratory that is outside the normal range at some time point during the study
Time frame: 52 weeks
The Incidence of ECG Abnormalities.
The number of patients who had a change in their ECG that were clinically significant
Time frame: 52 weeks
Duration of Response Per RECIST 1.1 in Phase 2
The length of response per RECIST 1.1 from the time of first response to progression or going off study in Phase 2
Time frame: 52 weeks