drugset / Trial / NCT03487055
Safety Assessment of Repeated Administration of TK006 in Patients With Breast Cancer-related Bone Metastases
NaSingle-groupOpen-labelTreatment
Summary
This is an open labelled study. It was designed to evaluate the safety of multiple-dosing of TK006 in patients with breast cancer-related bone metastases. This trial is the extension of a core study: Phase 1 Trial of a Fully Human Monoclonal Antibody of Receptor Activator for Nuclear Factor-κ B Ligand (RNAKL, TK006) Safety, Pharmacokinetics, and Pharmacodynamics in Patients With Breast Cancer-related Bone Metastases (NCT 03239756).
Timeline
- Start
- 2018-05
- Primary completion
- 2019-05
- Completion
- 2019-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Denosumab | Monoclonal antibody | 120 mg | Subcutaneous |