Clinical trial · Interventional
Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor
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)
NCT02471716CI-TRIAL-00053594FPA008-002completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of cabiralizumab in PVNS/dt-TGCT patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pigmented Villonodular Synovitis | Tenosynovial Giant Cell Tumor, Diffuse Type | ALIAS | 0.90 |
| Tenosynovial Giant Cell Tumor | Tenosynovial Giant Cell Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FPA008 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1 FPA008 Dose Escalation
- description
- 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.
- interventionNames
- Biological: FPA008
- type
- EXPERIMENTAL
- label
- Phase 2 FPA008 Dose Expansion
- description
- 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.
- interventionNames
- Biological: FPA008
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.