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Keep this study
Lead
Five Prime Therapeutics, Inc.
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).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor
