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

NCT03487055 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-04-03

No results posted yet for this study

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).

Conditions

Interventions

BIOLOGICAL

TK006

Subcutaneous injection in the upper arm

Sponsors & Collaborators

  • Jiangsu T-Mab Biopharma Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • jiang H Y · Jiangsu T-Mab Biopharma Co.,Ltd

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2019-05-31
Completion
2019-05-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03487055 on ClinicalTrials.gov