SHR-2017 injection for preventing bone events in people with solid tumors that have spread to bone

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2 interventional study testing SHR-2017 injection for preventing bone events in adults with solid tumors that have metastasized to bone. Participants who are 18 or older with confirmed solid tumors and at least one bone metastasis will receive SHR-2017, denosumab, or matching placebos while investigators monitor safety, dosing, and bone-related outcomes. Key enrollment requirements include ECOG performance status ≤2, adequate organ function, and a life expectancy of at least six months. The trial is sponsored by Suzhou Suncadia Biopharmaceuticals and is being conducted at Sun Yat-sen University Cancer Center in Guangzhou, China.

Why it matters

Who can join: the full rules

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. The subject's pain is predominantly from pain unrelated to the bone metastases;
7. Subject is unable to perform a pain assessment;
8. Symptomatic or treatment-requiring brain metastases or other central nervous system metastases
9. Comorbid infectious disease
10. Prior receipt of exogenous nerve growth factor or anti-nerve growth factor antibodies;
11. Prior history of allergy to relevant drug ingredients or components;
12. Participation in other clinical trials within a certain period of time
13. Subjects who, in the opinion of the investigator, have any other factors

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Qian Zhao
• Email: qian.zhao@hengrui.com
• Phone: +0518-82342973

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.