SHR-2017 injection for preventing bone events in people with solid tumors that have spread to bone
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
We are testing whether SHR-2017 injection can prevent bone complications in adults whose solid tumors have spread to bone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. Industry-sponsored |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07028268 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with histologically or cytologically confirmed solid tumors, at least one radiologically or pathologically confirmed bone metastasis, ECOG ≤2, adequate organ function, and a life expectancy of at least six months are the intended participants.
Not a fit: Patients with active oral disease requiring surgery, recent bone radiotherapy, major prior joint surgery, significant cardiovascular disease, or unstable resting heart rate may not benefit from participation.
Why it matters
Potential benefit: If SHR-2017 works as hoped, it could lower the risk of fractures, pain, and other bone-related complications in patients with bone metastases.
How similar studies have performed: Similar treatments targeting bone resorption, such as denosumab, have reduced skeletal complications in patients with bone metastases, so this approach builds on a previously successful mechanism though SHR-2017 itself is newly tested.
Eligibility criteria
Show full inclusion / exclusion 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. 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 this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Qian Zhao
- Email: qian.zhao@hengrui.com
- Phone: +0518-82342973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.