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

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

Sponsors

Lead Sponsor: AmMax Bio, Inc.

Source AmMax Bio, Inc.
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.

Overall Status Recruiting
Start Date 2021-03-17
Completion Date 2022-03-01
Primary Completion Date 2022-01-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Treatment-emergent adverse events Week 12
Tumor response based on RECIST Week 12
Secondary Outcome
Measure Time Frame
Tumor response based on tumor volume Week 12
Mean change from Baseline in range of motion (ROM) Week 12
Mean change from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function score Week 12
Mean change from Baseline in Worst Stiffness Numeric Rating Scale (NRS) score Week 12
Mean change from Baseline in Worst Pain NRS score Week 12
Mean change from Baseline in the Brief Pain Inventory (BPI) score Weeks 12
EQ-5D-5L Health Assessment Week 12
Enrollment 12
Condition
Intervention

Intervention Type: Biological

Intervention Name: AMB-05X

Description: A fully human monoclonal immunoglobulin (IgG2) directed against c-fms

Arm Group Label: AMB-05X

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Michael Huang, MD Study Chair AmMax Bio, Inc.
Overall Contact

Last Name: Tiffany Nguyen

Phone: 6502856560

Email: [email protected]

Location
Facility: Status:
AmMax Bio Clinical Site | Columbus, Ohio, 43201, United States Recruiting
AmMax Bio Clinical Site | Leiden, Netherlands Recruiting
AmMax Bio Clinical Site | Warsaw, Poland Recruiting
AmMax Bio Clinical Site | Dnipro, Ukraine Recruiting
AmMax Bio Clinical Site | Kharkiv, Ukraine Recruiting
AmMax Bio Clinical Site | Kyiv, Ukraine Recruiting
Location Countries

Netherlands

Poland

Ukraine

United States

Verification Date

2021-07-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: AMB-05X

Type: Experimental

Description: 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.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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