A Phase 2 interventional study of AMB-05X in Pigmented Villonodular Synovitis, TGCT and Tenosynovial Giant Cell Tumor, sponsored by AmMax Bio, Inc.. Completed at 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by AmMax Bio, Inc. · Phase 2, Interventional, and Treatment
AMB-051-07 is an open-label, adaptive, dose-ranging study with long-term extension in adults with tenosynovial giant cell tumor
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.
20 studies on the registry are indexed under Synovitis, Pigmented Villonodular; 2 are open to participants now.
This study's enrollment of 20 is below the median of 36 across 17 interventional studies indexed under Synovitis, Pigmented Villonodular.
Browse Synovitis, Pigmented Villonodular studies →AmMax Bio, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
Time frame: Part 1 Week 24
Treatment-emergent adverse events
Frequency and severity of reported treatment-emergent adverse events
Time frame: Part 1 Week 24 and Part 2 Week 72
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
Time frame: Part 2 Week 72
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)
Time frame: Part 2 Week 72
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)
Time frame: Part 1 Week 24
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)
Time frame: Part 2 Week 72
Tumor response based on tumor volume score (TVS)
Proportion of subjects who achieve an overall tumor response (OR) per the tumor volume score
Time frame: Part 1 Week 24
Tumor response based on tumor volume score (TVS)
Proportion of subjects who achieve an overall tumor response (OR) per the tumor volume score
Time frame: Part 2 Week 72
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)
Time frame: Part 1 Week 24
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)
Time frame: Part 2 Week 72
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)
Time frame: Part 1 Week 24
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)
Time frame: Part 2 Week 72
Duration of Response by tumor volume score
Median duration of response per tumor volume score (TVS)
Time frame: Part 1 Week 24
Duration of Response by tumor volume score
Median duration of response per tumor volume score (TVS)
Time frame: Part 2 Week 72
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)
Time frame: Part 1 Week 24
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)
Time frame: Part 2 Week 72
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)
Time frame: Part 1 week 24
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)
Time frame: Part 2 Week 72
Time to Response per tumor volume score
Time to response (TTR) per tumor volume score (TVS)
Time frame: Part 1 Week 24
Time to Response per tumor volume score
Time to response (TTR) per tumor volume score (TVS)
Time frame: Part 2 Week 72
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.
Time frame: Part 1 Week 24
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.
Time frame: Part 2 Week 72
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.
Time frame: Part 1 Week 24
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.
Time frame: Part 2 Week 72
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.
Time frame: Part 1 Week 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.
Time frame: Part 2 Week 72
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".
Time frame: Part 1 Week 24
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".
Time frame: Part 2 Week 72
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".
Time frame: Part 1 Week 24
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".
Time frame: Part 2 Week 72
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.
Time frame: Part 1 Week 24
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.
Time frame: Part 2 Week 72
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.
Time frame: Part 1 Week 24
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.
Time frame: Part 2 Week 72
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.
Time frame: Part 1 Week 24
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.
Time frame: Part 2 Week 72
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.
Time frame: Part 1 Week 24
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.
Time frame: Part 2 Week 72
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.
Time frame: Part 1 Week 24
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.
Time frame: Part 2 Week 72
Plan to share: No
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Ran from Jan 2023 to primary completion in Jun 2024, 16 months.
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Anti-CSF1R Monoclonal Antibody AMB-05X
Synovitis, Pigmented Villonodular →
AmMax Bio, Inc.