Phase 2
N=66
Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor
Pigmented Villonodular Synovitis · Tenosynovial Giant Cell Tumor
Bottom Line
View on ClinicalTrials.gov: NCT02471716 ↗Enrolled (actual)
66
Serious AEs
24.2%
Results posted
Aug 2021
Primary outcome: Primary: The Incidence of Grade 3 and Grade 4 Adverse Events (AEs) and Defined as Dose-limiting Toxicities (DLTs) in Phase 1 — 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- FPA008 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Five Prime Therapeutics, Inc.
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Incidence of Grade 3 and Grade 4 Adverse Events (AEs) and Defined as Dose-limiting Toxicities (DLTs) in Phase 1 |
0; 0; 0 | — |
| PRIMARY The Incidence of Investigator-assessed, Confirmed Objective Responses (ORR) Per RECIST 1.1 (Phase 2) |
8; 8 | — |
| SECONDARY PK Parameters of Cabiralizumab: Area Under Concentration-time Curve (AUC) |
102; 283; 593; 660; 593 | — |
| SECONDARY Maximum Serum Concentration (Cmax). |
22.5; 52.1; 91.2; 91.8; 87 | — |
| SECONDARY Minimum Serum Concentration (Cmin). |
2.18; 7.26; 21.2; 23.9; 22.6 | — |
| SECONDARY Pharmacokinetic Clearance (CL). |
.663; .416; .694; .307; .525 | — |
| SECONDARY The Incidence of AEs. |
3; 3; 3; 33; 24 | — |
| SECONDARY The Incidence of Clinical Laboratory Abnormalities. |
3; 2; 3; 33; 24 | — |
| SECONDARY The Incidence of ECG Abnormalities. |
0; 0; 0; 0; 0 | — |
| SECONDARY Duration of Response Per RECIST 1.1 in Phase 2 |
4.4; NA | — |
Summary
This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of cabiralizumab in PVNS/dt-TGCT patients.
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
Data sourced from ClinicalTrials.gov (NCT02471716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.