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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
SHR-2017
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The Pharmacokinetic parameters of SHR-2017 after administration, including Cmax
Time frame: First dose up to 169 days post-dose
The Pharmacokinetic parameters of SHR-2017 after administration, including Tmax
Time frame: First dose up to 169 days post-dose
The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-t
Time frame: First dose up to 169 days post-dose
The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-∞
Time frame: First dose up to 169 days post-dose
The Pharmacokinetic parameters of SHR-2017 after administration, including t1/2
Time frame: First dose up to 169 days post-dose
The Pharmacokinetic parameters of SHR-2017 after administration, including CL/F
Time frame: First dose up to 169 days post-dose
The pharmacodynamic parameter of SHR-2017 after administration include uNTX/uCr
Time frame: First dose up to 169 days post-dose
The pharmacodynamic parameter of SHR-2017 after administration include β-CTX
Time frame: First dose up to 169 days post-dose
The pharmacodynamic parameter of SHR-2017 after administration include BALP [Time
Time frame: First dose up to 169 days post-dose
Change from baseline in worst pain/average pain at the designated bone metastasis pain site after dosing
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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)
Time frame: First dose up to 169 days post-dose
Incidence of skeletal-related event
Time frame: First dose up to 169 days post-dose
Average daily total opioids consumption
Time frame: First dose up to 169 days post-dose]