Trials / Completed
CompletedNCT05349643
A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT
A Phase 2, Open-Label, Adaptive, Dose-Ranging Study With Long-Term Extension to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intra Articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- AmMax Bio, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
AMB-051-07 is an open-label, adaptive, dose-ranging study with long-term extension in adults with tenosynovial giant cell tumor
Detailed description
AMB-051-07 is an open-label, adaptive, dose-ranging study with long-term extension which will enroll up to 48 adult subjects with tenosynovial giant cell tumor for intra-articular doses over a 24-week dosing period (Part 1) with a Part 2 open-label extension of 6 treatment and/or observational cycles of 12 weeks each followed by 12 weeks of follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AMB-05X | A fully human monoclonal immunoglobulin (IgG2) directed against c-fms |
Timeline
- Start date
- 2023-01-26
- Primary completion
- 2024-06-03
- Completion
- 2024-06-03
- First posted
- 2022-04-27
- Last updated
- 2024-07-05
Locations
6 sites across 3 countries: United States, Australia, Netherlands
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05349643. Inclusion in this directory is not an endorsement.