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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMB-05X | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMB-05X | Biological | A fully human monoclonal immunoglobulin (IgG2) directed against c-fms |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | Part 1 Week 24 |
| Treatment-emergent adverse events | Frequency and severity of reported treatment-emergent adverse events | Part 1 Week 24 and Part 2 Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Part 2 Week 72 |
| Objective Response Rate (AMB-051-01 subjects) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dorothy Nguyen, MD | AmMax Bio | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AmMax Bio, Clinical Site | Sacramento | California | 95817 | United States | ||
| AmMax Bio, Clinical Site |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 6, 2026 | Jun 1, 2026 | 8 |
| ID | Term |
|---|---|
| D013586 | Synovitis, Pigmented Villonodular |
| D000070779 | Giant Cell Tumor of Tendon Sheath |
| ID | Term |
|---|---|
| D005870 | Giant Cell Tumors |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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None (Open Label)
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Proportion of re-treated subjects who achieve an OR (objective response rate [ORR]) by central radiology review per modified Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
| 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) | 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) | 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 | 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 | 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) | 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) | 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) | 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) | Part 2 Week 72 |
| Duration of Response by tumor volume score | Median duration of response per tumor volume score (TVS) | Part 1 Week 24 |
| Duration of Response by tumor volume score | Median duration of response per tumor volume score (TVS) | 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) | 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) | 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) | 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) | Part 2 Week 72 |
| Time to Response per tumor volume score | Time to response (TTR) per tumor volume score (TVS) | Part 1 Week 24 |
| Time to Response per tumor volume score | Time to response (TTR) per tumor volume score (TVS) | 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. | 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. | 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. | 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. | 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. | 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. | 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". | 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". | 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". | 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". | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Part 2 Week 72 |
| Miami |
| Florida |
| 33136 |
| United States |
| AmMax Bio, Clinical Site | Houston | Texas | 77030 | United States |
| AmMax Bio, Clinical Site | Camperdown | Australia |
| AmMax Bio, Clinical Site | Woolloongabba | Australia |
| AmMax Bio, Clinical Site | Leiden | Netherlands |
| D009369 | Neoplasms |
| D013585 | Synovitis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |