Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor

NCT02471716 | Completed Phase 1 Results DMC

• 1 other identifier: FPA008-002
• Study Type: interventional
• Target: 66
• Locations: 6 countries
• Sites: 12

Brief Summary

This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of cabiralizumab in PVNS/dt-TGCT patients.

Conditions

Pigmented Villonodular Synovitis; Tenosynovial Giant Cell Tumor

Keywords

Diffuse Type Tenosynovial Giant Cell Tumor (dt-TGCT)

Outcome Measures

Primary Outcomes (2)

• The Incidence of Grade 3 and Grade 4 Adverse Events (AEs) and Defined as Dose-limiting Toxicities (DLTs) in Phase 1

  Number of participants with grade 3 and grade 4 adverse events (AE) defined as dose limiting toxicities (DLTs) in Phase 1

  52 weeks

• The Incidence of Investigator-assessed, Confirmed Objective Responses (ORR) Per RECIST 1.1 (Phase 2)

  Number of confirmed objective responses (ORR) as assessed by the investigator per RECIST 1.1 (Phase 2)

  52 weeks

Secondary Outcomes (8)

• PK Parameters of Cabiralizumab: Area Under Concentration-time Curve (AUC)

  52 weeks

• Maximum Serum Concentration (Cmax).

  52 weeks

• Minimum Serum Concentration (Cmin).

  52 weeks

• Pharmacokinetic Clearance (CL).

  52 weeks

• The Incidence of AEs.

  52 weeks

Study Arms (2)

Phase 1 FPA008 Dose Escalation

EXPERIMENTAL

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.

Biological: FPA008

Phase 2 FPA008 Dose Expansion

EXPERIMENTAL

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.

Biological: FPA008

Interventions

FPA008 BIOLOGICAL

FPA008 will be administered by IV infusion over approximately 30 minutes every 2 or 4 weeks

Also known as: Cabiralizumab

Phase 1 FPA008 Dose Escalation; Phase 2 FPA008 Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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

Sponsors & Collaborators

• Five Prime Therapeutics, Inc.: lead

Study Sites (12)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Sarcoma Oncology Research Center LLC

Santa Monica, California, 90403, United States

Location

Stanford Medicine

Stanford, California, 94301-5821, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

The University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Institut Bergonie- CRLCC de Bordeaux et du Sud-Ouest

Bordeaux, 33076, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow, Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie

Warsaw, 02-781, Poland

Location

Seoul National University Hospital

Seoul, Jongno-gu, 110-744, South Korea

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2TH, United Kingdom

Location

Oxford University Hospital NHS Trust

Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Synovitis, Pigmented Villonodular; Giant Cell Tumor of Tendon Sheath

Interventions

cabiralizumab

Condition Hierarchy (Ancestors)

Giant Cell Tumors; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Synovitis; Joint Diseases; Musculoskeletal Diseases; Tendinopathy; Muscular Diseases

Results Point of Contact

• Title: Medical
• Organization: FivePrime Theraputics

nick.mahasuwan@fiveprime.com

415-365-5600

Study Officials

• Medical Lead

  Five Prime Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 15, 2015
• Study Start: June 1, 2015
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: August 31, 2021
• Results First Posted: August 31, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); PL (1); KR (1); GB (2); NL (1); US (5)