Phase 2
N=11
An Open-Label Study of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor of the Knee
Tenosynovial Giant Cell Tumor · Pigmented Villonodular Synovitis (PVNS)
Bottom Line
View on ClinicalTrials.gov: NCT04731675 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events — 7; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AMB-05X (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AmMax Bio, Inc.
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events |
7; 2 | — |
| SECONDARY Tumor Response Based on RECIST Version 1.1 |
3; 1 | — |
| SECONDARY Tumor Response Based on Tumor Volume (TV) |
2; 1 | — |
| SECONDARY Mean Change From Baseline in Range of Motion (ROM): Flexion |
7.1; 3.3 | — |
| SECONDARY Mean Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Score |
6.7; 8.7 | — |
| SECONDARY Mean Change From Baseline in Worst Stiffness Numeric Rating Scale (NRS) Score |
-2.4; -2.3 | — |
| SECONDARY Mean Change From Baseline in the Brief Pain Inventory (BPI) Pain Interference Index Score |
-2.8; -2.6 | — |
| SECONDARY EuroQol 5 Dimension 5 Level (EQ-5D-5L) Health Assessment |
-0.9; -0.7 | — |
| SECONDARY Percentage of Subjects Who Respond With a Decrease of at Least 30% in Mean Brief Pain Inventory (BPI) Score |
5; 2 | — |
| SECONDARY Serum Colony Stimulating Factor 1 (CSF1) Levels |
503; 1030 | — |
| SECONDARY Serum AMB-05X Levels |
2.1; 33.0 | — |
| SECONDARY Serum Anti-AMB-05X Antibody Levels |
0; 0; 3; 8 | — |
| SECONDARY Synovial Fluid CSF1 |
37.1; 22.6 | — |
| SECONDARY Synovial AMB-05X Levels |
36.3; 153 | — |
| SECONDARY Synovial Anti-AMB-05X Antibody (ADA) Levels |
1; 0; 2; 8 | — |
| SECONDARY Proportions of Subjects Who Achieved Objective Response as Their Best Overall Tumor Response, Per Modified Response Evaluation Criteria in Solid Tumors (RECIST). |
4; 1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04731675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.