At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 11 enrolled
Drug / intervention
AMB-05Xbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating AMB-05X for Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis (PVNS). Completed, enrolled 11 participants across 6 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands, Poland, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedFeb 2021
Enrollment StartMay 2021
Primary CompletionMay 2022
TodayJul 2026
First PostedFeb 1, 2021
Enrollment StartMay 25, 2021
Primary CompletionMay 5, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.4 years ago
Interventions
AMB-05Xbiological
AMB-05X is a fully human antibody antagonist (immunoglobulin G, type 2 \[IgG2\]) specific to the extracellular domain of human CSF1R