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Recruiting Phase 2 NCT07028268

A Trial of SHR-2017 Injection in Patients With Bone Metastases From Solid Tumors

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Trial Parameters

Condition For Prevention of Bone Events in Patients With Bone Metastases From Solid Tumors
Sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 210
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-06-24
Completion 2025-12
Interventions
SHR-2017、Denosumab placeboSHR-2017、Denosumab placeboDenosumab;SHR-2017 placebo

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Brief Summary

The study is being conducted to evaluate the efficacy, and safety of SHR-2017 Injection in Patients with Bone Metastases from Solid Tumors. To explore the reasonable dosage of SHR-2017 Injection for Bone Metastases from Solid Tumors

Eligibility Criteria

Inclusion Criteria: 1. Able and willing to provide a written informed consent; 2. Male or female, ≥18 years of age; 3. Histologically or cytologically confirmed solid tumors; 4. At least 1 bone metastasis demonstrated by radiologic imaging or histopathology; 5. Eastern Cooperative Oncology Group performance Status≤2。 6. Life expectancy was judged by the investigators to be at least 6 months; 7. Adequate organ function at Screening 8. Female subjects with a negative blood pregnancy test and are not breastfeeding Exclusion Criteria: 1. Pre-existing or comorbid related oral diseases or oral cavity requiring surgery, etc; 2. History of major joint (e.g., hip, knee, or shoulder) trauma or surgery prior to the first dose of the drug; 3. Received radiotherapeutic drugs or bone radiotherapy prior to the first study drug administration 4. Any cardiovascular disease for which the investigator considers the subject unfit to participate in the study 5. resting tachycardia or resting bradycardia; 6

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