A Phase 2 Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients (NCT04938180) | Clinical Trial Compass
TerminatedPhase 2
A Phase 2 Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients
Stopped: Further enrollment was halted in November 2021, enrolled subjects completed the study. Sponsor stopped further recruitment in this intravenous study to focus on intra-articular route of administration in subjects with tenosynovial giant cell tumor.
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject ≥ 18 years
✓. A confirmed diagnosis of TGCT
✓. Measurable disease based on RECIST v1.1
✓. Symptomatic disease
✓. Stable prescription of analgesic regimen
✓. Agrees to follow contraception guidelines
✓. Adequate hematologic, hepatic, and renal function, at Screening
✓. Willing and able to complete self-assessment instruments throughout the study
Exclusion criteria
✕. Prior investigational drug use within 4 weeks or 5 half-lives of Baseline
✕. Current or prior radiotherapy within 3 months before Baseline
✕. Current or prior active cancer within 3 years before Baseline that requires/required therapy (eg, surgery, chemotherapy, or radiation therapy)
✕. Known metastatic TGCT or malignant transformation of diffuse-type TGCT
✕. Hepatitis C virus (HCV) or hepatitis B virus (HBV) or known active or chronic infection with human immuno deficiency virus (HIV)