Status:
COMPLETED
An Open-Label Study of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor of the Knee
Lead Sponsor:
AmMax Bio, Inc.
Conditions:
Tenosynovial Giant Cell Tumor
Pigmented Villonodular Synovitis (PVNS)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
AMB-05X drug substance is a human monoclonal antibody against the colony-stimulating factor 1 receptor (CSF1R). Study
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2022
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04731675
Start Date
May 25 2021
End Date
May 5 2022
Last Update
June 27 2024
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
AmMax Bio Clinical Site
Columbus, Ohio, United States, 43201
2
AmMax Bio Clinical Site
Leiden, Netherlands
3
AmMax Bio Clinical Site
Warsaw, Poland
4
AmMax Bio Clinical Site
Dnipro, Ukraine