A Phase 2 Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients
Study Details
Study Description
Brief Summary
The purpose of this Phase 2, open-label, multiple-dose, dose-escalation study is to evaluate intravenous AMB-05X in the treatment of patients with TGCT.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort A Low-Dose AMB-05X Each subject will receive a low dose of AMB-05X every 2 weeks, for a total of 6 doses over the 12-week treatment period. |
Biological: AMB-05X
A fully human monoclonal immunoglobulin (IgG2) directed against c-fms
|
Outcome Measures
Primary Outcome Measures
- Overall tumor response per RECIST [Week 12]
Proportion of subjects achieving overall tumor response per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Secondary Outcome Measures
- Treatment-emergent adverse events [Up to week 24]
Frequency and severity of reported treatment-emergent adverse events
- Tumor response based on tumor volume [Week 12]
Proportion of subjects with overall response based on tumor volume score
- Mean change from baseline in range of motion (ROM) [Week 12]
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 the change in ROM subsequently.
- Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score [Week 12]
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 12]
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).
- Mean change from Baseline in Worst Pain NRS score [Week 12]
The Worst Pain NRS is a component of the Brief Pain Inventory assessing the "worst" pain in the last 24 hours. The NRS for this item ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
- Mean change from Baseline in the Brief Pain Inventory (BPI) score [Week 12]
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.
- EQ-5D-5L (EuroQol-5 Dimension-5 Level) Health Assessment [Week 12]
EQ-5D-5L (EuroQol-5 Dimension-5 Level) 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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A confirmed diagnosis of TGCT
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Measurable disease based on RECIST v1.1
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Symptomatic disease
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Stable prescription of analgesic regimen
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Agrees to follow contraception guidelines
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Adequate hematologic, hepatic, and renal function, at Screening
-
Willing and able to complete self-assessment instruments throughout the study
Exclusion Criteria:
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Prior investigational drug use within 4 weeks or 5 half-lives of Baseline
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Current or prior radiotherapy within 3 months before Baseline
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Current or prior active cancer within 3 years before Baseline that requires/required therapy (eg, surgery, chemotherapy, or radiation therapy)
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Known metastatic TGCT or malignant transformation of diffuse-type TGCT
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Hepatitis C virus (HCV) or hepatitis B virus (HBV) or known active or chronic infection with human immuno deficiency virus (HIV)
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Known active tuberculosis (TB)
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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 pregnant or breastfeeding
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Screening Fridericia-corrected QT interval(QTcF) ≥450ms (men) or ≥470ms (women)
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MRI contraindications (eg, pacemaker, loose metallic implants)
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History of hypersensitivity to any ingredient in the study drug
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History of drug or alcohol abuse within 3 months before Baseline
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Has 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, interfere with interpretation of study results, or, in the Investigator's opinion, make the subject inappropriate for this study
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A person who is held in detention as the result of a judicial or official decision or who is in a subordinate relationship to the Sponsor or Investigator
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A subject who, in the opinion of the Investigator, should not participate in the study for any reason, including if there is a question about the subject's ability to comply with study requirements
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AmMax Bio Clinical Site | Berlin | Germany | ||
| 2 | AmMax Bio Clinical Site | Warsaw | Poland | ||
| 3 | AmMax Bio Clinical Site | Dnipro | Ukraine | ||
| 4 | AmMax Bio Clinical Site | Kharkiv | Ukraine | ||
| 5 | AmMax Bio Clinical Site | Kyiv | Ukraine |
Sponsors and Collaborators
- AmMax Bio, Inc.
Investigators
- Study Chair: Dorothy Nguyen, MD, AmMax Bio, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AMB-051-02