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

July 3, 2024 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 in adults with tenosynovial giant cell tumor

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Camperdown, Australia
        • AmMax Bio, Clinical Site
      • Woolloongabba, Australia
        • AmMax Bio, Clinical Site
  • Netherlands
      • Leiden, Netherlands
        • AmMax Bio, Clinical Site
  • United States
    • California
      • Sacramento, California, United States, 95817
        • AmMax Bio, Clinical Site
    • Florida
      • Miami, Florida, United States, 33136
        • AmMax Bio, Clinical Site
    • Texas
      • Houston, Texas, United States, 77030
        • AmMax Bio, Clinical Site

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject ≥ 18 years
  2. TGCT with only 1 joint involvement
  3. Symptomatic Measurable disease of at least 1 cm based on RECIST v1.1
  4. Stable prescription of analgesic regimen
  5. Agrees to follow contraception guidelines
  6. Women of childbearing potential must have a negative pregnancy test
  7. Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

  1. Prior investigational drug use within 4 weeks or 5 half-lives of Baseline
  2. Previous use of therapeutics targeting CSF1 or CSF1R or oral tyrosine kinase inhibitors within 3 months prior to Baseline
  3. History of extensive or reconstructive surgery on the affected joint
  4. Active cancer (either currently or within 3 mo before Baseline) that requires/required therapy (e.g., surgery, chemotherapy, or radiation therapy)
  5. Metastatic or malignant transformation of TGCT
  6. Hepatitis C virus (HCV) or hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  7. Known active tuberculosis
  8. Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history
  9. Women who are breastfeeding
  10. A screening Fridericia-corrected QT interval (QTcF) ≥ 470 ms
  11. MRI contraindications (e.g., pacemaker, loose metallic implants)
  12. History of hypersensitivity to any ingredient of the study drug
  13. History of drug or alcohol abuse within 3 months before baseline
  14. 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
  15. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Biological: AMB-05X
A fully human monoclonal immunoglobulin (IgG2) directed against c-fms

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment-emergent adverse events
Time Frame: Part 1 Week 24 and Part 2 Week 72
Frequency and severity of reported treatment-emergent adverse events
Part 1 Week 24 and Part 2 Week 72
Objective Response Rate - Part 1
Time Frame: Part 1 Week 24
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)
Part 1 Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: Part 2 Week 72
Proportion of subjects who achieve an OR (objective response rate [ORR]) by central radiology review per modified Response Evaluation Criteria in Solid Tumors
Part 2 Week 72
Objective Response Rate (AMB-051-01 subjects)
Time Frame: Part 2 Week 72
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)
Part 2 Week 72
Objective Response Rate (ORR) per modified Response Evaluation Criteria in Solid Tumors Version 1.1
Time Frame: Part 1 Week 24
Proportion of subjects who achieve an overall response (OR) per modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Part 1 Week 24
Objective Response Rate (ORR) per modified Response Evaluation Criteria in Solid Tumors Version 1.1
Time Frame: Part 2 Week 72
Proportion of subjects who achieve an overall response (OR) per modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Part 2 Week 72
Tumor response based on tumor volume score (TVS)
Time Frame: Part 1 Week 24
Proportion of subjects who achieve an overall tumor response (OR) per the tumor volume score
Part 1 Week 24
Tumor response based on tumor volume score (TVS)
Time Frame: Part 2 Week 72
Proportion of subjects who achieve an overall tumor response (OR) per the tumor volume score
Part 2 Week 72
Duration of Response by Response Evaluation Criteria in Solid Tumors
Time Frame: Part 1 Week 24
Median duration of response per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Part 1 Week 24
Duration of Response by Response Evaluation Criteria in Solid Tumors v1.1
Time Frame: Part 2 Week 72
Median duration of response per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Part 2 Week 72
Duration of Response by Modified Response Evaluation Criteria in Solid Tumors
Time Frame: Part 1 Week 24
Median duration of response per modified Response Evaluation Criteria in Solid Tumors (modified RECIST)
Part 1 Week 24
Duration of Response by Modified Response Evaluation Criteria in Solid Tumors
Time Frame: Part 2 Week 72
Median duration of response per modified Response Evaluation Criteria in Solid Tumors (modified RECIST)
Part 2 Week 72
Duration of Response by tumor volume score
Time Frame: Part 1 Week 24
Median duration of response per tumor volume score (TVS)
Part 1 Week 24
Duration of Response by tumor volume score
Time Frame: Part 2 Week 72
Median duration of response per tumor volume score (TVS)
Part 2 Week 72
Time to Response by Response Evaluation Criteria in Solid Tumors
Time Frame: Part 1 Week 24
Time to response (TTR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Part 1 Week 24
Time to Response by Response Evaluation Criteria in Solid Tumors
Time Frame: Part 2 Week 72
Time to response (TTR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Part 2 Week 72
Time to Response by Modified Response Evaluation Criteria in Solid Tumors
Time Frame: Part 1 week 24
Time to response (TTR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Part 1 week 24
Time to Response by Modified Response Evaluation Criteria in Solid Tumors
Time Frame: Part 2 Week 72
Time to response (TTR) per modified Response Evaluation Criteria in Solid Tumors (modified RECIST)
Part 2 Week 72
Time to Response per tumor volume score
Time Frame: Part 1 Week 24
Time to response (TTR) per tumor volume score (TVS)
Part 1 Week 24
Time to Response per tumor volume score
Time Frame: Part 2 Week 72
Time to response (TTR) per tumor volume score (TVS)
Part 2 Week 72
Mean change from Baseline in joint range of motion (ROM)
Time Frame: Part 1 Week 24
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.
Part 1 Week 24
Mean change from Baseline in joint range of motion (ROM)
Time Frame: Part 2 Week 72
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.
Part 2 Week 72
Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score
Time Frame: Part 1 Week 24
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.
Part 1 Week 24
Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score
Time Frame: Part 2 Week 72
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.
Part 2 Week 72
Mean change from Baseline in Worst Stiffness Numeric Rating Scale score
Time Frame: Part 1 Week 24
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.
Part 1 Week 24
Mean change from Baseline in Worst Stiffness Numeric Rating Scale score
Time Frame: Part 2 Week 72
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.
Part 2 Week 72
Mean change from Baseline in the Brief Pain Inventory (BPI) score
Time Frame: Part 1 Week 24
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".
Part 1 Week 24
Mean change from Baseline in the Brief Pain Inventory (BPI) score
Time Frame: Part 2 Week 72
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".
Part 2 Week 72
Decrease of at least 30% in mean Brief Pain Inventory (BPI) from Baseline
Time Frame: Part 1 Week 24
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".
Part 1 Week 24
Decrease of at least 30% in mean Brief Pain Inventory (BPI) from Baseline
Time Frame: Part 2 Week 72
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".
Part 2 Week 72
Mean change from Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference score
Time Frame: Part 1 Week 24
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.
Part 1 Week 24
Mean change from Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference score
Time Frame: Part 2 Week 72
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.
Part 2 Week 72
Mean change from Baseline in Patient Global Impression of Change in Physical Functioning for capacity to perform everyday tasks
Time Frame: Part 1 Week 24
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.
Part 1 Week 24
Mean change from Baseline in Patient Global Impression of Change in Physical Functioning for capacity to perform everyday tasks
Time Frame: Part 2 Week 72
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.
Part 2 Week 72
Mean change from Baseline in Patient Global Impression of Change in tenosynovial giant cell tumor-related stiffness score
Time Frame: Part 1 Week 24
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.
Part 1 Week 24
Mean change from Baseline in Patient Global Impression of Change in tenosynovial giant cell tumor-related stiffness score
Time Frame: Part 2 Week 72
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.
Part 2 Week 72
Mean change from Baseline in Worst Pain Numeric Rating Scale score
Time Frame: Part 1 Week 24
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.
Part 1 Week 24
Mean change from Baseline in Worst Pain Numeric Rating Scale score
Time Frame: Part 2 Week 72
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.
Part 2 Week 72
EuroQol 5 Dimension 5 Level Health Assessment
Time Frame: Part 1 Week 24
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.
Part 1 Week 24
EuroQol 5 Dimension 5 Level Health Assessment
Time Frame: Part 2 Week 72
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.
Part 2 Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AmMax Bio, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 26, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 3, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 3, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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