Breast Cancer Clinical Trial
Official title:
Safety Assessment of Repeated Administration of a Fully Human Monoclonal Antibody of RNAKL (TK006) in Patients With Breast Cancer-related Bone Metastases
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).
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). It's an open labelled study, aimed at evaluating the safety of repeated
administration of TK006 in patients with breast cancer-related bone metastases. The qualified
subjects would be those completed the entire observation in either 60 mg, 120 mg or 180 mg
single dose arm at the core study. Also, these patients should be well-tolerated with TK006
at the core study and are deemed to further benefit from this extension phase estimated by
the researcher and sponsor. The subjects would receive 120 mg TK006 every 4-week over a
period of 84 days.
Only safety profile and immunogenicity assessment would be assessed in this extension stage,
and no further study on pharmacokinetics and pharmacodynamics would be done.
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