NCT04812509

Efficacy and Safety of MW032 and Xgeva® in Subjects With Bone Metastases From Solid Tumors

A Multi-center, Randomized, Double-blind, Parallel Controlled Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of Recombinant Human Anti RANKL Monoclonal Antibody Injection (MW032) and Denosumab (Xgeva®) in Subjects With Bone Metastases From Solid Tumors

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 708 (actual)
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multi-center, randomized, double-blind, parallel controlled Phase III clinical study to evaluate the clinical efficacy and safety of MW032 and Xgeva® in patients with bone metastases from solid tumors.

Detailed description

This is A multi-center, randomized, double-blind, parallel controlled Phase III clinical trial. The primary objective is to evaluate the clinical efficacy of MW032 and Xgeva® in patients with bone metastases from solid tumors. The secondary objective are to evaluate the clinical safety and immunogenicity of MW032 and Xgeva® in patients with bone metastases from solid tumors.

Conditions

• Bone Metastases

Interventions

Type	Name	Description
DRUG	MW032	The active ingredient of MW032 is a recombinant human anti-RANKL monoclonal antibody ,subcutaneous injection of 120 mg (1.7ml)every 4 weeks for a maximum of 13 consecutive doses throughout the trial.
DRUG	Xgeva	The active ingredient of Xgeva® is denosumab,subcutaneous injection of 120 mg (1.7ml)every 4 weeks for a maximum of 13 consecutive doses throughout the trial.

Timeline

• Start date: 2020-03-20
• Primary completion: 2021-04-29
• Completion: 2022-01-28
• First posted: 2021-03-23
• Last updated: 2023-02-24

Locations

1 site across 1 country: China