drugset / Trial / NCT03487055

Safety Assessment of Repeated Administration of TK006 in Patients With Breast Cancer-related Bone Metastases

NCT03487055

Phase 1 Unknown 30 enrolled Jiangsu T-Mab Biopharma Co.,Ltd
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

EvaluationDrugModalityDoseRoute
Subject Denosumab Monoclonal antibody 120 mg Subcutaneous

Indications