A Phase 2 Study With LTE to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT
Study Details
Study Description
Brief Summary
AMB-051-07 is an Open-Label, Adaptive, Dose-Ranging Study with Long-Term Extension which will enroll approximately 48 adult subjects with TGCT for IA doses over a 24-week dosing period (Part 1) with a Part 2 OLE of 6 treatment and/or observational cycles of 12 weeks each followed by 12 weeks of follow-up.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AMB-05X Subjects will receive an injection of AMB-05X once every 4 weeks for 24 weeks (for 6 treatments total). Based on ongoing review of the available safety, PK, PD, and efficacy data, the Sponsor may either increase or decrease the dose. |
Biological: AMB-05X
A fully human monoclonal immunoglobulin (IgG2) directed against c-fms
|
Outcome Measures
Primary Outcome Measures
- Treatment-emergent adverse events [Week 24]
Frequency and severity of reported treatment-emergent adverse events
Secondary Outcome Measures
- Tumor response based on RECIST [Week 24]
Proportion of subjects who achieve an overall tumor response per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- Mean change from Baseline in range of motion (ROM) [Week 24]
ROM of the joint will be assessed by qualified assessors. Measurements will be recorded in degrees. At baseline, the plane of movement with the smallest (worst) relative value will be identified; only this plane will be used for evaluating change in ROM subsequently.
- Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score [Week 24]
The PROMIS Physical Function Scale will be used to assess physical function. The scale ranges from 1 ('unable to do' or 'cannot do') to 5 ('without any difficulty' or 'not at all'), where higher scores represent better outcomes.
- Mean change from Baseline in Worst Stiffness Numeric Rating Scale (NRS) score [Week 24]
The Worst Stiffness NRS is a 1-item, self-administered questionnaire assessing the "worst" stiffness within the last 24 hours. The NRS for this item ranges from 0 (no stiffness) to 10 (stiffness as bad as you can imagine).
- Decrease of at least 30% in mean Brief Pain Inventory from Baseline [Week 24]
Brief Pain Inventory (BPI) Short Form is a self-administered questionnaire used to evaluate the severity of a subject's pain and the impact of this pain on the subject's daily functioning. The subject is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a scale from 0 to 10.
- Mean change from Baseline in the Brief Pain Inventory (BPI) score [Week 24]
Brief Pain Inventory (BPI) Short Form is a self-administered questionnaire used to evaluate the severity of a subject's pain and the impact of this pain on the subject's daily functioning. The subject is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a scale from 0 to 10.
- EuroQol 5 Dimension 5 Level (EQ-5D-5L) Health Assessment [Week 24]
EQ-5D-5L is a widely used quality of life instrument that includes questions in each of 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The choices include 5 levels of severity for each domain followed by a general health visual analogue scale (VAS).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject ≥ 18 years
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TGCT with only 1 joint involvement
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Measurable disease based on RECIST v1.1
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Stable prescription of analgesic regimen
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Agrees to follow contraception guidelines
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Women of childbearing potential must have a negative pregnancy test
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Adequate hematologic, hepatic, and renal function, at Screening
Exclusion Criteria:
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Prior investigational drug use within 4 weeks or 5 half-lives of Baseline
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Previous use of therapeutics targeting CSF1 or CSF1R or oral tyrosine kinase inhibitors
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History of extensive or reconstructive surgery on the affected joint
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Active cancer (either currently or within 3 mo before Baseline) that requires/required therapy (e.g., surgery, chemotherapy, or radiation therapy)
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Metastatic TGCT
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Hepatitis C virus (HCV) or hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
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Known active tuberculosis
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Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history
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Women who are breastfeeding
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A screening Fridericia-corrected QT interval (QTcF) ≥ 450 ms (men) or ≥ 470 ms (women)
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MRI contraindications (e.g., pacemaker, loose metallic implants)
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History of hypersensitivity to any ingredient of the study drug
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History of drug or alcohol abuse within 3 months before baseline
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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
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AmMax Bio, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AMB-051-07