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

Completed · Phase 2

Conditions studied: Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis (PVNS)

In brief

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.

Key facts

Study ID

NCT04731675

Run by

AmMax Bio, Inc.

People needed

11

Starts

2021-05-25

Expected to finish

2022-05-05

Last updated by the study team

2024-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Prior investigational drug use within 4 weeks or 5 half-lives of Baseline
• Previous use of therapeutics targeting CSF1 or CSF1R or oral tyrosine kinase inhibitors
• History of extensive knee surgery
• Active cancer (either currently or within 1 year before Baseline) that requires therapy (e.g., surgery, chemotherapy, or radiation therapy)
• Metastatic TGCT
• Hepatitis C virus (HCV) or hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
• Known active tuberculosis
• Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history
• Women who are breastfeeding
• A screening Fridericia-corrected QT interval (QTcF) ≥ 450 ms (men) or ≥ 470 ms (women)
• MRI contraindications (e.g., pacemaker, loose metallic implants)
• History of hypersensitivity to any ingredient of the study drug
• History of drug or alcohol abuse within 3 months before the first dose of study drug
• Any other severe acute or chronic medical or psychiatric condition or clinically significant laboratory abnormality that may increase the risk associated with study participation/treatment or interfere with interpretation of study results and, in the Investigator's opinion, make the subject inappropriate for this study
• Subjects who, in the Investigator's opinion, should not participate in the study for any reason, including if there is a question about their ability to comply with study requirements

Where it is running

• 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

Full record on ClinicalTrials.gov

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