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

Tenosynovial Giant Cell Tumor Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04731675
• Other study ID #: AMB-051-01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 25, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: July 2022
• Source: AmMax Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11
• Est. completion date: October 31, 2022
• Est. primary completion date: May 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Giant Cell Tumor of Tendon Sheath
• Giant Cell Tumors
• Pigmented Villonodular Synovitis
• Synovitis
• Synovitis, Pigmented Villonodular
• Tenosynovial Giant Cell Tumor

Intervention

Biological:
• AMB-05X
A fully human monoclonal immunoglobulin (IgG2) directed against c-fms

Locations

Country	Name	City	State
Netherlands	AmMax Bio Clinical Site	Leiden
Poland	AmMax Bio Clinical Site	Warsaw
Ukraine	AmMax Bio Clinical Site	Dnipro
Ukraine	AmMax Bio Clinical Site	Kharkiv
Ukraine	AmMax Bio Clinical Site	Kyiv
United States	AmMax Bio Clinical Site	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
AmMax Bio, Inc.

Countries where clinical trial is conducted

United States,  Netherlands,  Poland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-emergent adverse events	Frequency and severity of reported treatment-emergent adverse events	Week 12
Primary	Tumor response based on RECIST	Proportion of subjects who achieve an overall tumor response per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	Week 12
Secondary	Tumor response based on tumor volume	Proportion of subjects with overall response based on tumor volume score	Week 12
Secondary	Mean change from Baseline in range of motion (ROM)	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.	Week 12
Secondary	Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score	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.	Week 12
Secondary	Mean change from Baseline in Worst Stiffness Numeric Rating Scale (NRS) score	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).	Week 12
Secondary	Mean change from Baseline in Worst Pain NRS score	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).	Week 12
Secondary	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 to 10.	Weeks 12
Secondary	EQ-5D-5L Health Assessment	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).	Week 12