For Prevention of Bone Events in Patients With Bone Metastases From Solid Tumors
Conditions
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
Interventions
DRUGSHR-2017、Denosumab placebo
SHR-2017; high dose ；Denosumab placebo
DRUGDenosumab；SHR-2017 placebo
Denosumab；SHR-2017 placebo
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to pain relief | randomization to 48 weeks after administration | Analgesic evaluation using NRS scores |
| percentage of change in the bone turnover marker urine N-telopeptide corrected for urine creatinine (uNTx/Cr) from baseline to study week 13 | randomization to 13 weeks after administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in the daily worst pain intensity in the index bonemetastasis cancer pain site. | randomization to 48 weeks after administration |
| Time to first on-study SRE (defined as pathologic fracture, radiation or surgery to bone, or spinalcord compression). | randomization to 72 weeks after administration |
| Average daily total opioid consumption (in mg of morphine equivalent doses) | randomization to 48 weeks after administration |
| Response as defined by a ≥2 point reduction from Baseline in the daily average and daily worst pain intensity NRS score in the index bone metastasis cancer pain site | randomization to 48 weeks after administration |
| Change from Baseline in the daily average pain intensity in the index bonemetastasis cancer pain site. | randomization to 48 weeks after administration |
Countries
China
Contacts
Primary ContactQian Zhao
Outcome results
None listed