NCT04731675CompletedPhase 2
An Adaptive, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor of the Knee
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AmMax Bio, Inc.
- Enrollment
- 11
- Locations
- 6
- Primary Endpoint
- Number of Participants With Treatment-emergent Adverse Events
Study Overview
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-articular AMB-05X.
Detailed Description
AMB-05X drug substance is a human monoclonal antibody against the colony-stimulating factor 1 receptor (CSF1R). Study
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Number of Participants With Treatment-emergent Adverse Events
Time Frame: 24 weeks
Frequency and severity of reported treatment-emergent adverse events
Secondary Outcomes
- Serum Colony Stimulating Factor 1 (CSF1) Levels(week 10)
- Serum Anti-AMB-05X Antibody Levels(week 10)
- Mean Change From Baseline in Worst Stiffness Numeric Rating Scale (NRS) Score(Week 12)
- Mean Change From Baseline in the Brief Pain Inventory (BPI) Pain Interference Index Score(Week 12)
- Mean Change From Baseline in Range of Motion (ROM): Flexion(Week 12)
- Percentage of Subjects Who Respond With a Decrease of at Least 30% in Mean Brief Pain Inventory (BPI) Score(week 12)
- Synovial Anti-AMB-05X Antibody (ADA) Levels(Week 10)
- Tumor Response Based on Tumor Volume (TV)(Week 12)
- Synovial Fluid CSF1(Week 10)
- Tumor Response Based on RECIST Version 1.1(Week 12)
- Mean Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Score(Week 12)
- Serum AMB-05X Levels(week 10)
- Synovial AMB-05X Levels(Week 10)
- EuroQol 5 Dimension 5 Level (EQ-5D-5L) Health Assessment(Week 12)
- Proportions of Subjects Who Achieved Objective Response as Their Best Overall Tumor Response, Per Modified Response Evaluation Criteria in Solid Tumors (RECIST).(12 Weeks)
Investigators
Study Sites (6)
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