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Pigmented Villonodular SynovitisPhase 2NCT05349643

A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT

A Phase 2 study testing AMB-05X in people with Pigmented Villonodular Synovitis and TGCT, run by AmMax Bio, Inc. at 6 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

AMB-051-07 is an open-label, adaptive, dose-ranging study with long-term extension in adults with tenosynovial giant cell tumor Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AMB-05X
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
6 sitesin 3 countries
Study dates
26 Jan 2023to 3 Jun 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 15Show fewer
  • 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) ≥ 470 ms
  • 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

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

United States3 sites

  • AmMax Bio, Clinical Site

    Houston, Texas, 77030

  • AmMax Bio, Clinical Site

    Miami, Florida, 33136

  • AmMax Bio, Clinical Site

    Sacramento, California, 95817

Other trials in United States

Australia2 sites

  • AmMax Bio, Clinical Site

    Camperdown

  • AmMax Bio, Clinical Site

    Woolloongabba

Other trials in Australia

Netherlands1 site

  • AmMax Bio, Clinical Site

    Leiden

Other trials in Netherlands

About this study

Official title: 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 in adults with tenosynovial giant cell tumor

Read the detailed description

AMB-051-07 is an open-label, adaptive, dose-ranging study with long-term extension which will enroll up to 48 adult subjects with tenosynovial giant cell tumor for intra-articular doses over a 24-week dosing period (Part 1) with a Part 2 open-label extension of 6 treatment and/or observational cycles of 12 weeks each followed by 12 weeks of follow-up.

Being tested
AMB-05X
Keywords
Pigmented Villonodular Synovitis, Tenosynovial Giant Cell Tumor, TGCT, PVNS
Medical subject headings
Synovitis, Pigmented Villonodular, Giant Cell Tumor of Tendon Sheath

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMB-05XBiological

    A fully human monoclonal immunoglobulin (IgG2) directed against c-fms

Study groups in NCT05349643
Study groupRoleWhat they receive
AMB-05XExperimentalSubjects 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.
Receives: Biological: AMB-05X

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate - Part 1

    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)

    Measured: Part 1 Week 24

  2. Treatment-emergent adverse events

    Frequency and severity of reported treatment-emergent adverse events

    Measured: Part 1 Week 24 and Part 2 Week 72

Secondary outcomes (38)

  1. Objective Response Rate

    Proportion of subjects who achieve an OR (objective response rate [ORR]) by central radiology review per modified Response Evaluation Criteria in Solid Tumors

    Measured: Part 2 Week 72

  2. Objective Response Rate (AMB-051-01 subjects)

    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 (RECIST v1.1)

    Measured: Part 2 Week 72

  3. Objective Response Rate (ORR) per modified Response Evaluation Criteria in Solid Tumors Version 1.1

    Proportion of subjects who achieve an overall response (OR) per modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    Measured: Part 1 Week 24

  4. Objective Response Rate (ORR) per modified Response Evaluation Criteria in Solid Tumors Version 1.1

    Proportion of subjects who achieve an overall response (OR) per modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    Measured: Part 2 Week 72

  5. Tumor response based on tumor volume score (TVS)

    Proportion of subjects who achieve an overall tumor response (OR) per the tumor volume score

    Measured: Part 1 Week 24

  6. Tumor response based on tumor volume score (TVS)

    Proportion of subjects who achieve an overall tumor response (OR) per the tumor volume score

    Measured: Part 2 Week 72

  7. Duration of Response by Response Evaluation Criteria in Solid Tumors

    Median duration of response per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    Measured: Part 1 Week 24

  8. Duration of Response by Response Evaluation Criteria in Solid Tumors v1.1

    Median duration of response per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    Measured: Part 2 Week 72

  9. Duration of Response by Modified Response Evaluation Criteria in Solid Tumors

    Median duration of response per modified Response Evaluation Criteria in Solid Tumors (modified RECIST)

    Measured: Part 1 Week 24

  10. Duration of Response by Modified Response Evaluation Criteria in Solid Tumors

    Median duration of response per modified Response Evaluation Criteria in Solid Tumors (modified RECIST)

    Measured: Part 2 Week 72

  11. Duration of Response by tumor volume score

    Median duration of response per tumor volume score (TVS)

    Measured: Part 1 Week 24

  12. Duration of Response by tumor volume score

    Median duration of response per tumor volume score (TVS)

    Measured: Part 2 Week 72

  13. Time to Response by Response Evaluation Criteria in Solid Tumors

    Time to response (TTR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    Measured: Part 1 Week 24

  14. Time to Response by Response Evaluation Criteria in Solid Tumors

    Time to response (TTR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    Measured: Part 2 Week 72

  15. Time to Response by Modified Response Evaluation Criteria in Solid Tumors

    Time to response (TTR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    Measured: Part 1 week 24

  16. Time to Response by Modified Response Evaluation Criteria in Solid Tumors

    Time to response (TTR) per modified Response Evaluation Criteria in Solid Tumors (modified RECIST)

    Measured: Part 2 Week 72

  17. Time to Response per tumor volume score

    Time to response (TTR) per tumor volume score (TVS)

    Measured: Part 1 Week 24

  18. Time to Response per tumor volume score

    Time to response (TTR) per tumor volume score (TVS)

    Measured: Part 2 Week 72

  19. Mean change from Baseline in joint range of motion (ROM)

    Mean change in joint range of motion (ROM) 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.

    Measured: Part 1 Week 24

  20. Mean change from Baseline in joint range of motion (ROM)

    Mean change in joint range of motion (ROM) 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.

    Measured: Part 2 Week 72

  21. Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score

    The Patient-Reported Outcomes Measurement Information System (PROMIS) is a 10-question patient reported outcome instrument used to assess physical functioning based on use of the upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back) and on instrumental activities of daily living. Five questions address the degree to which subject's health limits activities; subjects select responses ranging from 1-cannot do to 5 - not at all. Five additional questions address the degree to which the subject is able to perform certain physical activities, and subjects select a response to each question that ranges from 1 ("cannot do") to 5 ("without any difficulty"). Raw scores are summarized, score range is 10 to 50.

    Measured: Part 1 Week 24

  22. Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score

    The Patient-Reported Outcomes Measurement Information System (PROMIS) is a 10-question patient reported outcome instrument used to assess physical functioning based on use of the upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back) and on instrumental activities of daily living. Five questions address the degree to which subject's health limits activities; subjects select responses ranging from 1-cannot do to 5 - not at all. Five additional questions address the degree to which the subject is able to perform certain physical activities, and subjects select a response to each question that ranges from 1 ("cannot do") to 5 ("without any difficulty"). Raw scores are summarized, score range is 10 to 50.

    Measured: Part 2 Week 72

  23. Mean change from Baseline in Worst Stiffness Numeric Rating Scale score

    The Worst Stiffness Numeric Rating Scale (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). Higher scores indicate worst stiffness.

    Measured: Part 1 Week 24

  24. Mean change from Baseline in Worst Stiffness Numeric Rating Scale score

    The Worst Stiffness Numeric Rating Scale (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). Higher scores indicate worst stiffness.

    Measured: Part 2 Week 72

  25. Mean change from Baseline in the Brief Pain Inventory (BPI) score

    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 ="no pain" to 10= "pain as bad as you can imagine".

    Measured: Part 1 Week 24

  26. Mean change from Baseline in the Brief Pain Inventory (BPI) score

    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 ="no pain" to 10="pain as bad as you can imagine".

    Measured: Part 2 Week 72

  27. Decrease of at least 30% in mean Brief Pain Inventory (BPI) from Baseline

    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 ="no pain" to 10="pain as bad as you can imagine".

    Measured: Part 1 Week 24

  28. Decrease of at least 30% in mean Brief Pain Inventory (BPI) from Baseline

    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 ="no pain" to 10="pain as bad as you can imagine".

    Measured: Part 2 Week 72

  29. Mean change from Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference score

    The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.1 Pain Interference Short Form 8a, is an 8 question instrument used to evaluate how much a subject's pain interferes with daily functioning. 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"). Higher scores indicate greater pain interference.

    Measured: Part 1 Week 24

  30. Mean change from Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference score

    The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.1 Pain Interference Short Form 8a, is an 8 question instrument used to evaluate how much a subject's pain interferes with daily functioning. 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"). Higher scores indicate greater pain interference.

    Measured: Part 2 Week 72

  31. Mean change from Baseline in Patient Global Impression of Change in Physical Functioning for capacity to perform everyday tasks

    The Patient Global Impression of Change (PGIC), also known as Subject Global Impression. For this study, subjects will rate how much their tenosynovial giant cell tumor (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" and rate their change in stiffness using the PGIC Stiffness scale (ranging from 1 "Very much improved" to 7 "Very much worse". Higher scores indicate greater restrictions.

    Measured: Part 1 Week 24

  32. Mean change from Baseline in Patient Global Impression of Change in Physical Functioning for capacity to perform everyday tasks

    The Patient Global Impression of Change (PGIC), also known as Subject Global Impression. For this study, subjects will rate how much their tenosynovial giant cell tumor (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" and rate their change in stiffness using the PGIC Stiffness scale (ranging from 1 "Very much improved" to 7 "Very much worse". Higher scores indicate greater restrictions.

    Measured: Part 2 Week 72

  33. Mean change from Baseline in Patient Global Impression of Change in tenosynovial giant cell tumor-related stiffness score

    The Patient Global Impression of Change (PGIC), also known as Subject Global Impression. For this study, subjects will rate how much their tenosynovial giant cell tumor (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". Higher scores indicate greater TGCT-related levels of stiffness.

    Measured: Part 1 Week 24

  34. Mean change from Baseline in Patient Global Impression of Change in tenosynovial giant cell tumor-related stiffness score

    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". Higher scores indicate greater TGCT-related levels of stiffness.

    Measured: Part 2 Week 72

  35. Mean change from Baseline in Worst Pain Numeric Rating Scale score

    The Worst Pain Numeric Rating Scale (NRS) is an item in the Brief Pain Inventory (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"). Higher scores indicate greater levels of pain.

    Measured: Part 1 Week 24

  36. Mean change from Baseline in Worst Pain Numeric Rating Scale score

    The Worst Pain Numeric Rating Scale (NRS) is an item in the Brief Pain Inventory (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"). Higher scores indicate greater levels of pain.

    Measured: Part 2 Week 72

  37. EuroQol 5 Dimension 5 Level Health Assessment

    EuroQol 5 Dimension 5 Level (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). This instrument is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "no problems" through "extreme problems". Higher scores indicate a lower quality of life.

    Measured: Part 1 Week 24

  38. EuroQol 5 Dimension 5 Level Health Assessment

    EuroQol 5 Dimension 5 Level (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). This instrument is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "no problems" through "extreme problems". Higher scores indicate a lower quality of life.

    Measured: Part 2 Week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2022
  2. Study start26 Jan 2023
  3. Primary completion3 Jun 2024
  4. Study completion3 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05349643
Sponsor's protocol ID
AMB-051-07
Status last verified
Jul 2024
First submitted
22 Apr 2022
Last updated
5 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AMB-05X in people with Pigmented Villonodular Synovitis and TGCT, run by AmMax Bio, Inc. at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Australia, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate - Part 1 (time frame: Part 1 Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05349643.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.

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