- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05349643
A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT
July 5, 2023 updated by: AmMax Bio, Inc.
A Phase 2, Open-Label, Adaptive, Dose-Ranging Study With Long-Term Extension to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intra Articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tiffany Nguyen
- Phone Number: 6502856560
- Email: clinical@ammaxbio.com
Study Locations
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Camperdown, Australia
- Recruiting
- AmMax Bio, Clinical Site
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Woolloongabba, Australia
- Recruiting
- AmMax Bio, Clinical Site
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Leiden, Netherlands
- Recruiting
- AmMax Bio, Clinical Site
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California
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Sacramento, California, United States, 95817
- Recruiting
- AmMax Bio, Clinical Site
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Florida
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Miami, Florida, United States, 33136
- Recruiting
- AmMax Bio, Clinical Site
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Texas
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Houston, Texas, United States, 77030
- Recruiting
- AmMax Bio, Clinical Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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 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 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) ≥ 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 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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A fully human monoclonal immunoglobulin (IgG2) directed against c-fms
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate for Part 1
Time Frame: Part 1 Week 24
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Proportion of subjects who achieve an OR (objective response rate [ORR]) by central radiology review per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
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Part 1 Week 24
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Treatment-emergent adverse events
Time Frame: Part 1 Week 24 and Part 2 Week 72
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Frequency and severity of reported treatment-emergent adverse events
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Part 1 Week 24 and Part 2 Week 72
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate
Time Frame: Part 2 Week 72
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Proportion of subjects who achieve an OR (objective response rate [ORR]) by central radiology review per modified Response Evaluation Criteria in Solid Tumors
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Part 2 Week 72
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Tumor response based on tumor volume score (TVS)
Time Frame: Part 1 Week 24 and Part 2 Week 72
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Proportion of subjects who achieve an overall tumor response (OR) per the tumor volume score
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Part 1 Week 24 and Part 2 Week 72
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Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score
Time Frame: Part 1 Week 24 and Part 2 Week 72
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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.
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Part 1 Week 24 and Part 2 Week 72
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Mean change from Baseline in Worst Stiffness Numeric Rating Scale (NRS) score
Time Frame: Part 1 Week 24 and Part 2 Week 72
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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).
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Part 1 Week 24 and Part 2 Week 72
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Decrease of at least 30% in mean Brief Pain Inventory from Baseline
Time Frame: Part 1 Week 24 and Part 2 Week 72
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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.
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Part 1 Week 24 and Part 2 Week 72
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Mean change from Baseline in the Brief Pain Inventory (BPI) score
Time Frame: Part 1 Week 24 and Part 2 Week 72
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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.
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Part 1 Week 24 and Part 2 Week 72
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Mean change from Baseline in Worst Pain NRS score
Time Frame: Part 1 Week 24 and Part 2 Week 72
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The Worst Pain NRS is an item in the BPI that assesses a subject's "worst" pain in the last 24 hours.
The 11-point NRS for this item ranges from 0 ("no pain") to 10 ("pain as bad as you can imagine").
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Part 1 Week 24 and Part 2 Week 72
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EuroQol 5 Dimension 5 Level (EQ-5D-5L) Health Assessment
Time Frame: Part 1 Week 24 and Part 2 Week 72
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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).
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Part 1 Week 24 and Part 2 Week 72
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Objective Response Rate (AMB-051-01 subjects)
Time Frame: Part 2 Week 72
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Proportion of re-treated subjects who achieve an OR (objective response rate [ORR]) by central radiology review per modified Response Evaluation Criteria in Solid Tumors
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Part 2 Week 72
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Objective Response Rate per modified RECIST
Time Frame: Part 1 Week 24 and Part 2 Week 72
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Proportion of subjects who achieve an overall response (OR) per modified RECIST
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Part 1 Week 24 and Part 2 Week 72
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Duration of Response
Time Frame: Part 1 Week 24 and Part 2 Week 72
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Median duration of response per RECIST v1.1, modified RECIST, and TVS
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Part 1 Week 24 and Part 2 Week 72
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Time to Response
Time Frame: Part 1 Week 24 and Part 2 Week 72
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Time to response (TTR) per RECIST v1.1, modified RECIST, and TVS
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Part 1 Week 24 and Part 2 Week 72
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Mean change from Baseline in joint range of motion (ROM)
Time Frame: Part 1 Week 24 and Part 2 Week 72
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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.
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Part 1 Week 24 and Part 2 Week 72
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Mean change from Baseline in PROMIS Pain Interference score
Time Frame: Part 1 Week 24 and Part 2 Week 72
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The PROMIS Item Bank v1.1 Pain Interference Short Form 8a, provided in Appendix 4, is an 8 question PRO instrument used to evaluate how much a subject's pain interferes with daily functioning (Health Measures, 2022).
Subjects rate the degree to which pain interfered with their daily activity over the past 7 days on a scale of 1 to 5 (ranging from 1, "Not at all," to 5, "Very much").
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Part 1 Week 24 and Part 2 Week 72
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Mean change from Baseline in Patient Global Impression of Change (PGIC) in Physical Functioning for capacity to perform everyday tasks
Time Frame: Part 1 Week 24 and Part 2 Week 72
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The Patient Global Impression of Change (PGIC), also known as Subject Global Impression.
For this study, subjects will rate how much their TGCT has restricted their ability to perform everyday tasks, using the following scales that are based on the PGIC: PGIC Physical Functioning scale (ranging from 1, "Not at all," to 5, "Extremely".
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Part 1 Week 24 and Part 2 Week 72
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Mean change from Baseline in PGIC in TGCT-related stiffness score
Time Frame: Part 1 Week 24 and Part 2 Week 72
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The Patient Global Impression of Change (PGIC), also known as Subject Global Impression.
For this study, subjects will rate how much their TGCT has restricted their ability to perform everyday tasks, using the PGIC to rate their change in stiffness using the PGIC Stiffness scale (ranging from 1, "Very much improved" to 7, "Very much worse".
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Part 1 Week 24 and Part 2 Week 72
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Dorothy Nguyen, MD, AmMax Bio
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 26, 2023
Primary Completion (Estimated)
November 1, 2025
Study Completion (Estimated)
January 1, 2026
Study Registration Dates
First Submitted
April 22, 2022
First Submitted That Met QC Criteria
April 22, 2022
First Posted (Actual)
April 27, 2022
Study Record Updates
Last Update Posted (Actual)
July 7, 2023
Last Update Submitted That Met QC Criteria
July 5, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMB-051-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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