A Phase 2 interventional study of AMB-05X in Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis and TGCT, sponsored by AmMax Bio, Inc.. Terminated at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-24.
Sponsored by AmMax Bio, Inc. · Phase 2, Interventional, and Treatment
The purpose of this Phase 2, open-label, multiple-dose, dose-escalation study is to evaluate intravenous AMB-05X in the treatment of subjects with TGCT.
AMB-05X drug substance is a human monoclonal antibody against the colony-stimulating factor 1 receptor (CSF1R).
20 studies on the registry are indexed under Synovitis, Pigmented Villonodular; 2 are open to participants now.
This study's enrollment of 4 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.
Compared within Synovitis, Pigmented Villonodular, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Giant Cell Tumor of Tendon Sheath. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
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.
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.
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
AMB-05X is a fully human antibody antagonist (immunoglobulin G, type 2 \[IgG2\]) specific to the extracellular domain of human CSF1R
Treatment-emergent Adverse Events (TEAEs)
The frequency and severity of reported TEAEs in Subjects with Tenosynovial Giant Cell Tumor (TGCT) receiving Intravenous AMB 05X.
Time frame: 6 months
Overall Tumor Response (Objective Response) Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; Per RECIST v1.0 for target lesions and assessed by MRI: A Complete Response (CR) is defined as disappearance of all tumors. A Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target tumors from the baseline sum of diameters.
Time frame: 12 weeks
Overall Response Based on Tumor Volume Score (TVS)
Tumor Volume Score (TVS) calculates tumor volume as a percentage of the estimated volume of the maximally distended synovial cavity or tendon sheath and provides a score in 10% increments. A score of 0 indicates no evidence of tumor; a score of 10 indicates a tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath. Complete response (CR): lesion is completely gone; Partial response (PR): \>/=50% decrease in TVS relative to Baseline; Progressive disease (PD): \>/= 30% increase in TVS relative to the lowest score during the study; Stable disease (SD): does not meet any of the other classifications.
Time frame: 24 weeks or ET visit
Mean Change From Baseline Range of Motion (ROM) (Flexion, Knee) Scores
Mean Change from Baseline in Range of Motion (ROM) Scores - Flexion (knee only). ROM is assessed by qualified assessors and recorded in degrees. At Baseline, the plane of movement with the smallest (worst) relative ROM was identified; only this plane was used for evaluating change in ROM. Higher scores indicate greater range of motion.
Time frame: week 12
Mean Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Score
Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score is used to assess physical function. 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 the subject's health limits activities, and subjects select a response that ranges 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. The score range is 10 to 50, higher scores = worse physical function
Time frame: 12 weeks
Serum Cmax for AMB-05X at Week 10 Post Dose
The maximum concentration of AMB-05X in subject serum is measured at week 10 postdose, using sensitive enzyme-linked immunosorbent assay analyses (ELISA).
Time frame: 10 weeks
Number of Subjects With Anti-Drug Antibodies to AMB-05X at Week 10
AMB-05X Anti-drug Antibodies (ADA) in subject serum will be measured from pre-dose samples.
Time frame: 10 weeks
Mean Change From Baseline in Worst Stiffness Numeric Rating Scale (NRS) Score
The mean changes from Baseline in the Worst Stiffness Numeric Rating Scale (NRS) score, a Patient-Reported Outcome (PRO) Measurement. The Worst Stiffness NRS is a single-item instrument designed to assess "worst" stiffness at the site of the tumor in the last 24 hours. The instrument uses an 11-point numeric rating scale that ranges from 0 ("no stiffness") to 10 ("stiffness as bad as you can imagine"). Higher scores indicate worse stiffness.
Time frame: 12 weeks
Brief Pain Inventory Pain Severity Domain Score
The mean changes from Baseline in Brief Pain Inventory (BPI) Pain Severity Domain. (Score of 0-10, where a negative score from baseline indicates a better BPI score, less severe pain) Brief Pain Inventory (BPI) 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. For the Pain Severity domain the subject is asked to rate their worst, least, average, and current pain intensity, and list current treatments and their perceived effectiveness on a scale from 0 to 10, where higher scores mean more severe pain. All of the 0-10 scores are averaged to obtain the total Domain (subscale) Score.
Time frame: 12 weeks
Mean Change From Baseline in Brief Pain Inventory Severity Interference
The mean changes from Baseline in Brief Pain Inventory (BPI) Severity Interference domain. The BPI Short Form is a patient-reported outcome instrument used to evaluate the severity of a subject's pain and the impact of this pain on the subject's daily functioning. For this domain, 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, where higher scores mean more pain interference. The reported score is the mean of the seven interference items. Higher scores indicate greater levels of pain.
Time frame: 12 weeks
Worst Pain Numeric Rating Scale Score
Mean change from Baseline in Worst Pain Numeric Rating Scale score. The Worst Pain Numeric Rating Scale is an item in the BPI that assesses a subject's "worst" pain in the last 24 hours. The 11-point Numeric Rating Scale for this item ranges from 0 ("no pain") to 10 ("pain as bad as you can imagine"). Higher scores indicate greater level of pain.
Time frame: 12 weeks
EuroQol 5 Dimension 5 Level Health Assessment
Mean change from Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L) assessment Scale Score (5-25). 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: 12 weeks
Colony-stimulating Factor 1 Levels
Serum colony-stimulating factor-1 (CSF-1) levels are measured in patient/subject serum. Samples were collected for measurement of CSF-1 at least once at specified visits.
Time frame: 10 weeks
Mean Change From Baseline Rnge of Motion (Flexion, Ankle) Scores
Mean Change from Baseline in Range of Motion (ROM) Scores - Flexion (Ankle only). ROM is assessed by qualified assessors and recorded in degrees. At Baseline, the plane of movement with the smallest (worst) relative ROM was to be identified; only this plane was used for evaluating change in ROM. Higher scores indicate greater range of motion.
Time frame: week 12
Serum AMB-05X-Binding Anti-drug Antibody (ADA) Levels
Series analysis for anti-drug antibody detection and titer
Time frame: Week 12
| Milestone | Subjects With Tenosynovial Giant Cell Tumor |
|---|---|
| Started | 4 |
| Completed | 3 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
The frequency and severity of reported TEAEs in Subjects with Tenosynovial Giant Cell Tumor (TGCT) receiving Intravenous AMB 05X.
| Participants | Cohort A: Subjects With TGCT |
|---|---|
| Number of subjects with treatment-emergent adverse events | 4 |
| Number of subjects without treatment-emergent adverse events | 0 |
Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; Per RECIST v1.0 for target lesions and assessed by MRI: A Complete Response (CR) is defined as disappearance of all tumors. A Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target tumors from the baseline sum of diameters.
| Participants | Cohort A: Subjects With TGCT |
|---|---|
| Subjects with CR | 0 |
| Subjects with PR | 1 |
| Subjects with stable disease | 2 |
Tumor Volume Score (TVS) calculates tumor volume as a percentage of the estimated volume of the maximally distended synovial cavity or tendon sheath and provides a score in 10% increments. A score of 0 indicates no evidence of tumor; a score of 10 indicates a tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath. Complete response (CR): lesion is completely gone; Partial response (PR): \>/=50% decrease in TVS relative to Baseline; Progressive disease (PD): \>/= 30% increase in TVS relative to the lowest score during the study; Stable disease (SD): does not meet any of the other classifications.
| Participants | Cohort A: Subjects With TGCT |
|---|---|
| Subjects with CR | 0 |
| Subjects with PR | 0 |
| Subjects with SD | 3 |
Mean Change from Baseline in Range of Motion (ROM) Scores - Flexion (knee only). ROM is assessed by qualified assessors and recorded in degrees. At Baseline, the plane of movement with the smallest (worst) relative ROM was identified; only this plane was used for evaluating change in ROM. Higher scores indicate greater range of motion.
| Participants | Cohort A: Subjects With TGCT |
|---|---|
| Subjects with no change in ROM from baseline | 1 |
| Subjects with change in ROM Left Knee | 1 |
| Subjects with change in ROM Right Knee | 1 |
Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score is used to assess physical function. 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 the subject's health limits activities, and subjects select a response that ranges 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. The score range is 10 to 50, higher scores = worse physical function
| score on a scale | Cohort A: Subjects With TGCT |
|---|---|
| Mean Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Score | 0 ± 2.65 |
The maximum concentration of AMB-05X in subject serum is measured at week 10 postdose, using sensitive enzyme-linked immunosorbent assay analyses (ELISA).
| ng/mL | Cohort A: Subjects With TGCT |
|---|---|
| Serum Cmax for AMB-05X at Week 10 Post Dose | 54,457 ± 30,356 |
AMB-05X Anti-drug Antibodies (ADA) in subject serum will be measured from pre-dose samples.
| Participants | Subjects With Tenosynovial Giant Cell Tumor |
|---|---|
| Subjects ADA positive at any visit analyzed | 1 |
| Subjects ADA negative at every visit analyzed | 3 |
The mean changes from Baseline in the Worst Stiffness Numeric Rating Scale (NRS) score, a Patient-Reported Outcome (PRO) Measurement. The Worst Stiffness NRS is a single-item instrument designed to assess "worst" stiffness at the site of the tumor in the last 24 hours. The instrument uses an 11-point numeric rating scale that ranges from 0 ("no stiffness") to 10 ("stiffness as bad as you can imagine"). Higher scores indicate worse stiffness.
| score on a scale | Cohort A: Subjects With TGCT |
|---|---|
| Mean Change From Baseline in Worst Stiffness Numeric Rating Scale (NRS) Score | -2.7 ± 2.52 |
The mean changes from Baseline in Brief Pain Inventory (BPI) Pain Severity Domain. (Score of 0-10, where a negative score from baseline indicates a better BPI score, less severe pain) Brief Pain Inventory (BPI) 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. For the Pain Severity domain the subject is asked to rate their worst, least, average, and current pain intensity, and list current treatments and their perceived effectiveness on a scale from 0 to 10, where higher scores mean more severe pain. All of the 0-10 scores are averaged to obtain the total Domain (subscale) Score.
| score on a scale | Cohort A: Subjects With TGCT |
|---|---|
| Brief Pain Inventory Pain Severity Domain Score | -0.83 ± 1.665 |
The mean changes from Baseline in Brief Pain Inventory (BPI) Severity Interference domain. The BPI Short Form is a patient-reported outcome instrument used to evaluate the severity of a subject's pain and the impact of this pain on the subject's daily functioning. For this domain, 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, where higher scores mean more pain interference. The reported score is the mean of the seven interference items. Higher scores indicate greater levels of pain.
| score on a scale | Cohort A: Subjects With TGCT |
|---|---|
| Mean Change From Baseline in Brief Pain Inventory Severity Interference | 0.81 ± 1.528 |
Mean change from Baseline in Worst Pain Numeric Rating Scale score. The Worst Pain Numeric Rating Scale is an item in the BPI that assesses a subject's "worst" pain in the last 24 hours. The 11-point Numeric Rating Scale for this item ranges from 0 ("no pain") to 10 ("pain as bad as you can imagine"). Higher scores indicate greater level of pain.
| score on a scale | Cohort A: Subjects With TGCT |
|---|---|
| Worst Pain Numeric Rating Scale Score | -0.3 ± 1.53 |
Mean change from Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L) assessment Scale Score (5-25). 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.
| score on a scale | Cohort A: Subjects With TGCT |
|---|---|
| EuroQol 5 Dimension 5 Level Health Assessment | -0.3 ± 0.58 |
Serum colony-stimulating factor-1 (CSF-1) levels are measured in patient/subject serum. Samples were collected for measurement of CSF-1 at least once at specified visits.
| pg/mL | Cohort A: Subjects With TGCT |
|---|---|
| Colony-stimulating Factor 1 Levels | 1216 ± 372 |
Mean Change from Baseline in Range of Motion (ROM) Scores - Flexion (Ankle only). ROM is assessed by qualified assessors and recorded in degrees. At Baseline, the plane of movement with the smallest (worst) relative ROM was to be identified; only this plane was used for evaluating change in ROM. Higher scores indicate greater range of motion.
No measurements were reported for this outcome.
Series analysis for anti-drug antibody detection and titer
| Participants | Subjects With Tenosynovial Giant Cell Tumor |
|---|---|
| Baseline visit — Subjects ADA negative | 3 |
| Baseline visit — Subjects ADA positive | 1 |
| Visit 7 — Subjects ADA negative | 2 |
| Visit 7 — Subjects ADA positive | 1 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tenosynovial Giant Cell Tumor - Events During Initial Treatment Period | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Tenosynovial Giant Cell Tumor - Events During Maintenance Treatment Period | 0/4 (0%) | 0/4 (0%) | 4/4 (100%) |
| Event | Tenosynovial Giant Cell Tumor - Events During Initial Treatment Period | Tenosynovial Giant Cell Tumor - Events During Maintenance Treatment Period |
|---|---|---|
| face edemaGeneral disorders | 0/4 | 4/4 |
| blood lactate dehydrogenase increasedInvestigations | 0/4 | 2/4 |
| hepatic enzyme increasedInvestigations | 0/4 | 1/4 |
| epistaxisRespiratory, thoracic and mediastinal disorders | 0/4 | 1/4 |
| hypertensionVascular disorders | 0/4 | 1/4 |
| headacheNervous system disorders | 0/4 | 1/4 |
| rash maculopapularSkin and subcutaneous tissue disorders | 0/4 | 1/4 |
| skin hyperpigmentationSkin and subcutaneous tissue disorders | 0/4 | 1/4 |
| diarrheaGastrointestinal disorders | 0/4 | 1/4 |
| aspartate aminotransferase increasedInvestigations | 0/4 | 1/4 |
A total of 48 subjects were planned. However, enrollment into the study was stopped in November 2021 after 4 subjects were enrolled to focus more on AMB-05X intra-articular administration.
| Age, Categorical(Participants) | Cohort A: Subjects With TGCT |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Cohort A: Subjects With TGCT |
|---|---|
| Female | 4 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Cohort A: Subjects With TGCT |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 4 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Cohort A: Subjects With TGCT |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Cohort A: Subjects With TGCT |
|---|---|
| Hungary | 1 |
| Ukraine | 2 |
| Poland | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Anti-CSF1R Monoclonal Antibody AMB-05X
Synovitis, Pigmented Villonodular →
AmMax Bio, Inc.