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To evaluate the pharmacokinetic characteristics, pharmacodynamic characteristics, safety, tolerability and immunogenicity of SHR-2017 injection in patients with bone metastases, and to evaluate the efficacy of SHR-2017 injection in the treatment of skeletal-related event and cancer pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-2017 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2017 | Drug | SHR-2017 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Pharmacokinetic parameters of SHR-2017 after administration, including Cmax | First dose up to 169 days post-dose | |
| The Pharmacokinetic parameters of SHR-2017 after administration, including Tmax | First dose up to 169 days post-dose | |
| The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-t | First dose up to 169 days post-dose | |
| The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-∞ | First dose up to 169 days post-dose | |
| The Pharmacokinetic parameters of SHR-2017 after administration, including t1/2 | First dose up to 169 days post-dose | |
| The Pharmacokinetic parameters of SHR-2017 after administration, including CL/F | First dose up to 169 days post-dose | |
| The pharmacodynamic parameter of SHR-2017 after administration include uNTX/uCr | First dose up to 169 days post-dose | |
| The pharmacodynamic parameter of SHR-2017 after administration include β-CTX | First dose up to 169 days post-dose | |
| The pharmacodynamic parameter of SHR-2017 after administration include BALP [Time | First dose up to 169 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in worst pain/average pain at the designated bone metastasis pain site after dosing | Worst pain / average pain was assessed on an 11-point numeric rating scale (NRS) ,The participant described the worst pain/average pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain) | First dose up to 169 days post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
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| Incidence of skeletal-related event | First dose up to 169 days post-dose |
| Average daily total opioids consumption | First dose up to 169 days post-dose] |