Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor (FPA008-002)
Pigmented Villonodular Synovitis, Tenosynovial Giant Cell Tumor
About this trial
This is an interventional treatment trial for Pigmented Villonodular Synovitis focused on measuring Diffuse Type Tenosynovial Giant Cell Tumor (dt-TGCT)
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of inoperable PVNS/ dt-TGCT or potentially resectable tumor that would result in unacceptable functional loss or morbidity as determined by a qualified surgeon or multi-disciplinary tumor board (must be documented in the CRF during screening)
- Measurable PVNS/dt-TGCT by RECIST 1.1 on MRI
- ECOG performance status <1
Exclusion Criteria:
- Prior therapy with an anti-CSF1R antibody
- Prior therapy with PLX3397 unless discontinued for intolerance (i.e., non-progression on prior kinase inhibitor)
- Liver function tests (including ALT, AST, and total bilirubin), outside of the range of local laboratory normal at Screening
- Inadequate organ or bone marrow function
- History of congestive heart failure or myocardial infarction <1 year prior to first study dose administration
- Significant abnormalities on ECG at Screening
- Contraindications to MRI and use of intravenous gadolinium-based contrast agents
- Creatine Kinase ≥ 1.5x the upper limit of normal
- Positive test for latent TB at Screening (Quantiferon test)
- Active known or suspected autoimmune disease
Sites / Locations
- Cedars-Sinai Medical Center
- Sarcoma Oncology Research Center LLC
- Stanford Medicine
- Dana-Farber Cancer Institute
- The University of Texas, MD Anderson Cancer Center
- Institut Bergonie- CRLCC de Bordeaux et du Sud-Ouest
- Centre Léon Bérard
- Seoul National University Hospital
- Leiden University Medical Center
- Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow, Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie
- University Hospitals Birmingham NHS Foundation Trust
- Oxford University Hospital NHS Trust
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Phase 1 FPA008 Dose Escalation
Phase 2 FPA008 Dose Expansion
IV infusion; safety data will be reviewed prior to dose escalation decision. Dose escalation will complete when recommended dose (RD) is determined. RD will be the maximum tolerated dose or lower dose that provide adequate PK exposure and biologic activity with tolerability.
IV infusion; once MTD and/or RD has been determined in Phase 1, expansion cohorts of approximately 30 patients (each cohort) with PVNS or dt-TGCT will be enrolled to characterize clinical activity and safety profile of the RD. Treatment is planned to continue for up to 24 weeks or 56 weeks.