NCT04731675

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: AmMax Bio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

AMB-051-01 is a multicenter study with an adaptive design that will enroll subjects with Tenosynovial Giant Cell Tumor (TGCT) of the knee for 12 weeks of multiple-dose, open-label treatment with intra-articular AMB-05X.

Detailed description

AMB-05X drug substance is a human monoclonal antibody against the colony-stimulating factor 1 receptor (CSF1R). Study

Conditions

• Tenosynovial Giant Cell Tumor
• Pigmented Villonodular Synovitis (PVNS)

Interventions

Type	Name	Description
BIOLOGICAL	AMB-05X	AMB-05X is a fully human antibody antagonist (immunoglobulin G, type 2 \[IgG2\]) specific to the extracellular domain of human CSF1R

Timeline

• Start date: 2021-05-25
• Primary completion: 2022-05-05
• Completion: 2022-05-05
• First posted: 2021-02-01
• Last updated: 2024-06-27
• Results posted: 2024-06-27

Locations

6 sites across 4 countries: United States, Netherlands, Poland, Ukraine

Regulatory

• FDA-regulated drug study