An Open-Label Study of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor of the Knee
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|ClinicalTrials.gov Identifier: NCT04731675|
Recruitment Status : Not yet recruiting
First Posted : February 1, 2021
Last Update Posted : February 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Tenosynovial Giant Cell Tumor Pigmented Villonodular Synovitis||Biological: AMB-05X||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Adaptive, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor of the Knee|
|Estimated Study Start Date :||February 2021|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||August 2021|
Subjects will receive an injection of AMB-05X once every 2 weeks for 12 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.
A fully human monoclonal immunoglobulin (IgG2) directed against c-fms
- Treatment-emergent adverse events [ Time Frame: Week 12 ]Frequency and severity of reported treatment-emergent adverse events
- Tumor response based on RECIST [ Time Frame: Week 12 ]Proportion of subjects who achieve an overall tumor response per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- Tumor response based on tumor volume [ Time Frame: Week 12 ]Proportion of subjects with overall response based on tumor volume score
- Mean change from Baseline in range of motion (ROM) [ Time Frame: Week 12 ]ROM of the joint 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.
- Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score [ Time Frame: Week 12 ]The PROMIS Physical Function Scale will be used to assess physical function. The scale ranges from 1 ('unable to do' or 'cannot do') to 5 ('without any difficulty' or 'not at all'), where higher scores represent better outcomes.
- Mean change from Baseline in Worst Stiffness Numeric Rating Scale (NRS) score [ Time Frame: Week 12 ]The Worst Stiffness 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).
- Mean change from Baseline in Worst Pain NRS score [ Time Frame: Week 12 ]The Worst Pain NRS is a component of the Brief Pain Inventory assessing the "worst" pain in the last 24 hours. The NRS for this item ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
- Mean change from Baseline in the Brief Pain Inventory (BPI) score [ Time Frame: Weeks 12 ]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 to 10.
- EQ-5D-5L Health Assessment [ Time Frame: Week 12 ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04731675
|Contact: Tiffany Nguyenfirstname.lastname@example.org|
|Study Chair:||Michael Huang, MD||AmMax Bio, Inc.|