Clinical trial · Interventional
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
NCT07028268CI-TRIAL-00099957recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| For Prevention of Bone Events in Patients With Bone Metastases From Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Denosumab;SHR-2017 placebo | Drug | — | UNRESOLVED |
| SHR-2017、Denosumab placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Treatment group A: SHR-2017、Denosumab placebo
- interventionNames
- Drug: SHR-2017、Denosumab placebo
- type
- EXPERIMENTAL
- label
- Treatment group B: SHR-2017、Denosumab placebo
- interventionNames
- Drug: SHR-2017、Denosumab placebo
- type
- ACTIVE_COMPARATOR
- label
- Treatment group C: Denosumab;SHR-2017 placebo
- interventionNames
- Drug: Denosumab;SHR-2017 placebo
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.