Trials / Terminated
TerminatedNCT04938180
A Phase 2 Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients
A Phase 2, Adaptive, Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Intravenous AMB-05X in Subjects With Tenosynovial Giant Cell Tumor
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- AmMax Bio, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this Phase 2, open-label, multiple-dose, dose-escalation study is to evaluate intravenous AMB-05X in the treatment of subjects with TGCT.
Detailed description
AMB-05X drug substance is a human monoclonal antibody against the colony-stimulating factor 1 receptor (CSF1R).
Conditions
- Tenosynovial Giant Cell Tumor
- Pigmented Villonodular Synovitis
- TGCT
- PVNS - Pigmented Villonodular Synovitis
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
- 2021-09-16
- Primary completion
- 2022-04-20
- Completion
- 2022-05-17
- First posted
- 2021-06-24
- Last updated
- 2024-05-24
- Results posted
- 2024-05-24
Locations
5 sites across 3 countries: Hungary, Poland, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04938180. Inclusion in this directory is not an endorsement.