Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04731675
Previous Study | Return to List | Next Study

An Open-Label Study of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor of the Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04731675
Recruitment Status : Not yet recruiting
First Posted : February 1, 2021
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
AmMax Bio, Inc.

Tracking Information
First Submitted Date  ICMJE January 19, 2021
First Posted Date  ICMJE February 1, 2021
Last Update Posted Date February 1, 2021
Estimated Study Start Date  ICMJE February 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2021)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2021)
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label Study of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor of the Knee
Official Title  ICMJE 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
Brief Summary AMB-051-01 is a multicenter study with an adaptive design that will enroll approximately 12 subjects with TGCT of the knee for 12 weeks of multiple-dose, open-label treatment with AMB-05X.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Tenosynovial Giant Cell Tumor
  • Pigmented Villonodular Synovitis
Intervention  ICMJE Biological: AMB-05X
A fully human monoclonal immunoglobulin (IgG2) directed against c-fms
Study Arms  ICMJE Experimental: AMB-05X

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.

Intervention: Biological: AMB-05X
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 26, 2021)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject ≥ 18 years
  2. A confirmed diagnosis of TGCT of the knee joint
  3. Measurable disease based on RECIST v1.1
  4. Stable prescription of analgesic regimen
  5. Negative urine drug screen (UDS) at Screening and Baseline
  6. Women of childbearing potential must have a negative pregnancy test
  7. Agrees to follow contraception guidelines
  8. Adequate hematologic, hepatic, and renal function, at Screening
  9. Willing and able to complete self-assessment instruments throughout the study

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
  3. History of extensive knee surgery
  4. Active cancer (either currently or within 1 year before Baseline) that requires therapy (e.g., surgery, chemotherapy, or radiation therapy)
  5. Metastatic 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) ≥ 450 ms (men) or ≥ 470 ms (women)
  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 the first dose of study drug
  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tiffany Nguyen 6502856560 clinical@ammaxbio.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04731675
Other Study ID Numbers  ICMJE AMB-051-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AmMax Bio, Inc.
Study Sponsor  ICMJE AmMax Bio, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Michael Huang, MD AmMax Bio, Inc.
PRS Account AmMax Bio, Inc.
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP