Columbus, Ohio 43201

  • Pigmented Villonodular Synovitis

Purpose:

AMB-051-01 is a multicenter study with an adaptive design that will enroll approximately 12 subjects with TGCT of the knee for 12 weeks of multiple-dose, open-label treatment with AMB-05X.


Criteria:

Inclusion Criteria: 1. Subject ≥ 18 years 2. A confirmed diagnosis of 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) 11. MRI contraindications (e.g., pacemaker, loose metallic implants) 12. History of hypersensitivity to any ingredient of the study drug 13. History of drug or alcohol abuse within 3 months before the first dose of study drug 14. 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 15. 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


NCT ID:

NCT04731675


Primary Contact:

Study Chair
Michael Huang, MD
AmMax Bio, Inc.

Tiffany Nguyen
Phone: 6502856560
Email: clinical@ammaxbio.com


Backup Contact:

N/A


Location Contact:

Columbus, Ohio 43201
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 20, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.