A Phase 1/2 Study of Cabiralizumab, an Anti-CSF1 Receptor Antibody, in Patients With Pigmented Villonodular Synovitis (PVNS)/ Diffuse Type Tenosynovial Giant Cell Tumor (Dt-TGCT)
Status: Completed
Location: See all (12) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of cabiralizumab in PVNS/dt-TGCT patients.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Cedars-Sinai Medical Center
Los Angeles
Sarcoma Oncology Research Center LLC
Santa Monica
Stanford Medicine
Stanford
Massachusetts
Dana-Farber Cancer Institute
Boston
Texas
The University of Texas, MD Anderson Cancer Center
Houston
Other Locations
France
Institut Bergonie- CRLCC de Bordeaux et du Sud-Ouest
Bordeaux
Centre Léon Bérard
Lyon
Netherlands
Leiden University Medical Center
Leiden
Poland
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow, Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie
Warsaw
Republic of Korea
Seoul National University Hospital
Seoul
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham
Oxford University Hospital NHS Trust
Oxford
Time Frame
Start Date: 2015-06
Completion Date: 2020-04-30
Participants
Target number of participants: 66
Treatments
Experimental: Phase 1 FPA008 Dose Escalation
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.
Experimental: Phase 2 FPA008 Dose Expansion
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.
Authors
Related Therapeutic Areas
Sponsors
Leads: Five Prime Therapeutics, Inc.