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A Study to Assess the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors Treated With JMT103 Compared to Zoledronic Acid
Sponsor: Shanghai JMT-Bio Inc.
Summary
This is a phase Ⅲ, multicenter, randomized, double-blind, study to evaluate the efficacy and safety of JMT103 in patients with bone metastases from malignant solid tumors. The purpose of this study is to determine if JMT103 is non-inferior to zoledronic acid.
Official title: A Phase III, Multicenter, Randomized, Double-blind Clinical Trail to Assess JMT103 Compared to Azoledronic Acid for the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1360
Start Date
2024-04-05
Completion Date
2028-05-31
Last Updated
2024-01-24
Healthy Volunteers
No
Interventions
JMT103
120 mg by subcutaneous injection every 4 weeks
zoledronic acid
4 mg by intravenous drip (100mL:4mg) every 4 weeks