Musculoskeletal Diseases

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Wounds and Injuries

Nervous System Diseases

Rare Diseases

Synovitis

Giant Cell Tumors

Giant Cell Tumor of Tendon Sheath

Synovitis, Pigmented Villonodular

Joint Diseases

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Tendinopathy

Muscular Diseases

Pigmented Villonodular Synovitis

All Drugs and Chemicals

Antibodies

Immunoglobulins

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.

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.

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

FPA008

Medical Lead

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

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).

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)

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

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

Area under serum concentration-time curve (AUC) for cabiralizumab as a PK parameter

Composite PK parameters of cabiralizumab: Maximum observed serum concentration

Composite PK parameters of cabiralizumab: minimum serum concentration (Cmin).

Composite PK parameters of cabiralizumab: clearance (CL)

treatment-emergent adverse events (TEAEs) by incidence for the Safety Population. Patients with at lease 1 TEAE.

The number of patients with a clinical laboratory that is outside the normal range at some time point during the study

The number of patients who had a change in their ECG that were clinically significant

The length of response per RECIST 1.1 from the time of first response to progression or going off study in Phase 2

Five Prime Therapeutics, Inc.

Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks

Phase 1 FPA008 Dose Escalation 1mg/kg

Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks

Phase 1 FPA008 Dose Escalation 2mg/kg

Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks

Phase 1 FPA008 Dose Escalation 4mg/kg

Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.

Phase 2 FPA008 Dose Expansion Cohort 2A

Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.

Phase 2 FPA008 Dose Expansion Cohort 2B

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

American Indian/alaska Native

Black

Native Hawaiian/Pacific Islander

White

Asian

Other

Unknown

Race/Ethnicity, Customized

Medical

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

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

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

Maximum Serum Concentration (Cmax).

Minimum Serum Concentration (Cmin).

Pharmacokinetic Clearance (CL).

The Incidence of AEs.

The Incidence of Clinical Laboratory Abnormalities.

The changes in the ECG parameters were not clinically significant in any dosing cohort in the study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor	NCT02471716	Pigmented Villo... Tenosynovial Gi...	FPA008	18 Years -	Five Prime Therapeutics, Inc.
Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor	NCT02471716	Pigmented Villo... Tenosynovial Gi...	FPA008	18 Years -	Five Prime Therapeutics, Inc.

Spots Global Cancer Trial Database for fpa008

Every month we try and update this database with for fpa008 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fpa008

Every month we try and update this database with for fpa008 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fpa008 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.