A Trial of SHR-2017 Injection in Patients With Bone Metastases From Solid Tumors
A Multicenter, Randomized, Double-Blind, Positively Controlled Phase II Clinical Study Evaluating the Efficacy and Safety of SHR-2017 Injection in Patients With Bone Metastases From Solid Tumors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
210 participants
Jun 24, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- Able and willing to provide a written informed consent；
- Male or female, ≥18 years of age；
- Histologically or cytologically confirmed solid tumors；
- At least 1 bone metastasis demonstrated by radiologic imaging or histopathology；
- Eastern Cooperative Oncology Group performance Status≤2。
- Life expectancy was judged by the investigators to be at least 6 months;
- Adequate organ function at Screening
- Female subjects with a negative blood pregnancy test and are not breastfeeding
Exclusion Criteria13
- Pre-existing or comorbid related oral diseases or oral cavity requiring surgery, etc；
- History of major joint (e.g., hip, knee, or shoulder) trauma or surgery prior to the first dose of the drug；
- Received radiotherapeutic drugs or bone radiotherapy prior to the first study drug administration
- Any cardiovascular disease for which the investigator considers the subject unfit to participate in the study
- resting tachycardia or resting bradycardia;
- The subject's pain is predominantly from pain unrelated to the bone metastases;
- Subject is unable to perform a pain assessment;
- Symptomatic or treatment-requiring brain metastases or other central nervous system metastases
- Comorbid infectious disease
- Prior receipt of exogenous nerve growth factor or anti-nerve growth factor antibodies;
- Prior history of allergy to relevant drug ingredients or components;
- Participation in other clinical trials within a certain period of time
- Subjects who, in the opinion of the investigator, have any other factors
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Interventions
SHR-2017; high dose ；Denosumab placebo
SHR-2017; low dose ；Denosumab placebo
Denosumab；SHR-2017 placebo
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07028268