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A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase 2, Open-Label, Adaptive, Dose-Ranging Study With Long-Term Extension to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intra Articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor

NCT05349643•AmMax Bio, Inc.

View on ClinicalTrials.gov

Summary

AMB-051-07 is an open-label, adaptive, dose-ranging study with long-term extension in adults with tenosynovial giant cell tumor

Detailed Description

AMB-051-07 is an open-label, adaptive, dose-ranging study with long-term extension which will enroll up to 48 adult subjects with tenosynovial giant cell tumor for intra-articular doses over a 24-week dosing period (Part 1) with a Part 2 open-label extension of 6 treatment and/or observational cycles of 12 weeks each followed by 12 weeks of follow-up.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject ≥ 18 years
•2. TGCT with only 1 joint involvement
•3. Symptomatic Measurable disease of at least 1 cm based on RECIST v1.1
•4. Stable prescription of analgesic regimen
•5. Agrees to follow contraception guidelines
•6. Women of childbearing potential must have a negative pregnancy test
•7. Adequate hematologic, hepatic, and renal function

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 within 3 months prior to Baseline
•3. History of extensive or reconstructive surgery on the affected joint
•4. Active cancer (either currently or within 3 mo before Baseline) that requires/required therapy (e.g., surgery, chemotherapy, or radiation therapy)
•5. Metastatic or malignant transformation of 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) ≥ 470 ms
+5 more criteria

Locations (6)

AmMax Bio, Clinical Site

Sacramento, California, United States

AmMax Bio, Clinical Site

Miami, Florida, United States

AmMax Bio, Clinical Site

Houston, Texas, United States

AmMax Bio, Clinical Site

Camperdown, Australia

AmMax Bio, Clinical Site

Woolloongabba, Australia

AmMax Bio, Clinical Site

Leiden, Netherlands

Key Dates

Start Date

January 26, 2023

Primary Completion Date

June 3, 2024

Completion Date

June 3, 2024

Last Updated

July 5, 2024

Enrollment

ACTUAL participants

Conditions

Pigmented Villonodular SynovitisTGCTTenosynovial Giant Cell Tumor

Interventions

AMB-05X

BIOLOGICAL

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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: July 5, 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.

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

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

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

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

Study of Nilotinib Efficacy in Pigmented Villo-Nodular Synovitis/ Tenosynovial Giant Cell Tumour (PVNS/TGCT)