This is a multicenterrandomized, 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.
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.
| Condition | Bone Metastases From Solid Tumors |
|---|---|
| Treatment | Xgeva®, LY01011 |
| Clinical Study Identifier | NCT04859569 |
| Sponsor | Luye Pharma Group Ltd. |
| Last Modified on | 22 September 2023 |
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