Status:
COMPLETED
A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT
Lead Sponsor:
AmMax Bio, Inc.
Conditions:
Pigmented Villonodular Synovitis
TGCT
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Subject ≥ 18 years
- TGCT with only 1 joint involvement
- Symptomatic Measurable disease of at least 1 cm based on RECIST v1.1
- Stable prescription of analgesic regimen
- Agrees to follow contraception guidelines
- Women of childbearing potential must have a negative pregnancy test
- Adequate hematologic, hepatic, and renal function
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 within 3 months prior to Baseline
- History of extensive or reconstructive surgery on the affected joint
- Active cancer (either currently or within 3 mo before Baseline) that requires/required therapy (e.g., surgery, chemotherapy, or radiation therapy)
- Metastatic or malignant transformation of 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) ≥ 470 ms
- 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 baseline
- 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 :
January 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05349643
Start Date
January 26 2023
End Date
June 3 2024
Last Update
July 5 2024
Active Locations (6)
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1
AmMax Bio, Clinical Site
Sacramento, California, United States, 95817
2
AmMax Bio, Clinical Site
Miami, Florida, United States, 33136
3
AmMax Bio, Clinical Site
Houston, Texas, United States, 77030
4
AmMax Bio, Clinical Site
Camperdown, Australia