Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT04859569
Brief Summary:
This is a multicenter，randomized, 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.
Detailed 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:
NCT04859569
Study Brief:
Protocol Section:
NCT04859569