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An Open-Label Study of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor of the Knee | Clinical Trials | Clareo Health

COMPLETEDPHASE2

An Open-Label Study of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor of the Knee

An Adaptive, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor of the Knee

NCT04731675•AmMax Bio, Inc.

View on ClinicalTrials.gov

Summary

AMB-051-01 is a multicenter study with an adaptive design that will enroll subjects with Tenosynovial Giant Cell Tumor (TGCT) of the knee for 12 weeks of multiple-dose, open-label treatment with intra-articular AMB-05X.

Detailed Description

AMB-05X drug substance is a human monoclonal antibody against the colony-stimulating factor 1 receptor (CSF1R). Study

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject ≥ 18 years
•2. A confirmed diagnosis of tenosynovial giant cell tumor (TGCT) of the knee joint
•3. Measurable disease based on RECIST v1.1
•4. Stable prescription of analgesic regimen
•5. Negative urine drug screen (UDS) at Screening and Baseline
•6. Women of childbearing potential must have a negative pregnancy test
•7. Agrees to follow contraception guidelines
•8. Adequate hematologic, hepatic, and renal function, at Screening
•9. Willing and able to complete self-assessment instruments throughout the study

Exclusion Criteria

•1. Prior investigational drug use within 4 weeks or 5 half-lives of Baseline
•2. Previous use of therapeutics targeting CSF1 or CSF1R or oral tyrosine kinase inhibitors
•3. History of extensive knee surgery
•4. Active cancer (either currently or within 1 year before Baseline) that requires therapy (e.g., surgery, chemotherapy, or radiation therapy)
•5. Metastatic TGCT
•6. Hepatitis C virus (HCV) or hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
•7. Known active tuberculosis
•8. Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history
•9. Women who are breastfeeding
•10. A screening Fridericia-corrected QT interval (QTcF) ≥ 450 ms (men) or ≥ 470 ms (women)
+5 more criteria

Locations (6)

AmMax Bio Clinical Site

Columbus, Ohio, United States

AmMax Bio Clinical Site

Leiden, Netherlands

AmMax Bio Clinical Site

Warsaw, Poland

AmMax Bio Clinical Site

Dnipro, Ukraine

AmMax Bio Clinical Site

Kharkiv, Ukraine

AmMax Bio Clinical Site

Kyiv, Ukraine

Key Dates

Start Date

May 25, 2021

Primary Completion Date

May 5, 2022

Completion Date

May 5, 2022

Last Updated

June 27, 2024

Enrollment

ACTUAL participants

Conditions

Tenosynovial Giant Cell TumorPigmented Villonodular Synovitis (PVNS)

Interventions

AMB-05X

BIOLOGICAL

A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment

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HepatotoxicityTenosynovial Giant Cell Tumor

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ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

An Open-Label Study of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor of the Knee

Inclusion Criteria

Exclusion Criteria

A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment

Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor

A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT

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