A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT

NCT05349643 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: AMB-051-07
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 6

Brief Summary

AMB-051-07 is an open-label, adaptive, dose-ranging study with long-term extension in adults with tenosynovial giant cell tumor

Conditions

Pigmented Villonodular Synovitis; TGCT; Tenosynovial Giant Cell Tumor

Keywords

Pigmented Villonodular Synovitis; Tenosynovial Giant Cell Tumor; TGCT; PVNS

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (38)

• Objective Response Rate

  Part 2 Week 72

• Objective Response Rate (AMB-051-01 subjects)

  Part 2 Week 72

• Objective Response Rate (ORR) per modified Response Evaluation Criteria in Solid Tumors Version 1.1

  Part 1 Week 24

• Objective Response Rate (ORR) per modified Response Evaluation Criteria in Solid Tumors Version 1.1

  Part 2 Week 72

• Tumor response based on tumor volume score (TVS)

  Part 1 Week 24

Study Arms (1)

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.

Biological: AMB-05X

Interventions

AMB-05X BIOLOGICAL

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

AMB-05X

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject ≥ 18 years
• TGCT with only 1 joint involvement
• Symptomatic Measurable disease of at least 1 cm based on RECIST v1.1
• Stable prescription of analgesic regimen
• Agrees to follow contraception guidelines
• Women of childbearing potential must have a negative pregnancy test
• Adequate hematologic, hepatic, and renal function

You may not qualify if:

• Prior investigational drug use within 4 weeks or 5 half-lives of Baseline
• Previous use of therapeutics targeting CSF1 or CSF1R or oral tyrosine kinase inhibitors within 3 months prior to Baseline
• History of extensive or reconstructive surgery on the affected joint
• Active cancer (either currently or within 3 mo before Baseline) that requires/required therapy (e.g., surgery, chemotherapy, or radiation therapy)
• Metastatic or malignant transformation of TGCT
• Hepatitis C virus (HCV) or hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
• Known active tuberculosis
• Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history
• Women who are breastfeeding
• A screening Fridericia-corrected QT interval (QTcF) ≥ 470 ms
• MRI contraindications (e.g., pacemaker, loose metallic implants)
• History of hypersensitivity to any ingredient of the study drug
• History of drug or alcohol abuse within 3 months before baseline
• 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
• 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

Sponsors & Collaborators

• AmMax Bio, Inc.: lead

Study Sites (6)

AmMax Bio, Clinical Site

Sacramento, California, 95817, United States

Location

AmMax Bio, Clinical Site

Miami, Florida, 33136, United States

Location

AmMax Bio, Clinical Site

Houston, Texas, 77030, United States

Location

AmMax Bio, Clinical Site

Camperdown, Australia

Location

AmMax Bio, Clinical Site

Woolloongabba, Australia

Location

AmMax Bio, Clinical Site

Leiden, Netherlands

Location

MeSH Terms

Conditions

Synovitis, Pigmented Villonodular; Giant Cell Tumor of Tendon Sheath

Condition Hierarchy (Ancestors)

Giant Cell Tumors; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Synovitis; Joint Diseases; Musculoskeletal Diseases; Tendinopathy; Muscular Diseases

Study Officials

• Dorothy Nguyen, MD

  AmMax Bio

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 27, 2022
• Study Start: January 26, 2023
• Primary Completion: June 3, 2024
• Study Completion: June 3, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); AU (2); US (3)