The purpose of this study was to observe and evaluate the tolerability, safety, and pharmacokinetics of HRS-1167 combined with abiraterone acetate tablets (II) and prednisone in patients with metastatic prostate cancer, determine the RP2D, and evaluate the effectiveness.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
The First Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, China
RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
RECRUITINGDose limiting toxicity (DLT)
Time frame: 28 days
Recommended phase II dose (RP2D)
Time frame: 28 days
The dose suspension rate caused by drug-related adverse events
Time frame: 2 years
The dose downregulation rate caused by drug-related adverse events
Time frame: 2 years
The dose termination rate caused by drug-related adverse events
Time frame: 2 years
PSA response rate
Time frame: 1 year
Time to PSA progression as assessed by the investigator
Time frame: 1 year
Objective response rate (ORR)
Time frame: 1 year
Disease control rate (DCR)
Time frame: 1 year
Duration of response (DoR)
Time frame: 1 year
Time to remission (TTR)
Time frame: 1 year
Radiographic progression-free survival (rPFS)
Time frame: 1 year
Overall survival (OS)
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Time frame: 3 years
Steady-state peak concentration (Cmax,ss) of HRS-1167
Time frame: 16 weeks
Adverse events
Time frame: 2 years
12-lead electrocardiogram
Time frame: 2 years
ECOG score
Time frame: 2 years
Steady-state peak time (Tmax,ss) of HRS-1167
Time frame: 16 weeks
Steady-state valley concentration (Cmin,ss)
Time frame: 16 weeks
Steady-state area under the concentration-time curve (AUCss)
Time frame: 16 weeks