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Clinical Trial Summary

This is a multicenter´╝îrandomized, double-blind, active-controlled, parallel-group study comparing efficacy and safety of LY01011 (recombinant anti-RANKL human monoclonal antibody injection) and Xgeva® in patients with bone metastases from solid tumors.


Clinical Trial Description

The primary objective is to evaluate the similarity of clinical efficacy between LY01011 and Xgeva® in patients with bone metastases from solid tumors. The secondary objective is to evaluate the similarity of clinical safety and immunogenicity between LY01011 and Xgeva® in patients with bone metastases from solid tumors. Each subject will participate in the study for 53 weeks. Treatments are administered on day 1 and Q4W thereafter through week 49. All patients are instructed to take 500 mg calcium and 400 IU vitamin D daily. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04859569
Study type Interventional
Source Luye Pharma Group Ltd.
Contact Xichun Hu, Professor
Phone 021-64175590
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date April 20, 2021
Completion date June 30, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04630522 - Efficacy and Safety of JMT103 in Patients With Bone Metastases From Solid Tumors Phase 1