The purpose of this study is to evaluate the efficacy, and safety of HRS-5041 tablets combined with antitumor therapy in subjects with advanced prostate cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
RECRUITINGShanghai Jiao Tong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGRecommended phase II dose (Phase Ib)
Time frame: 21 or 28 days
Incidence and severity of adverse events (AE) (Phase Ib)
Time frame: 2 years
PSA response rate (Phase II)
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
PSA response rate
Time frame: 1 year
Time to PSA progression
Time frame: 1 year
Radiographic progression-free survival (rPFS)
Time frame: 1 year
Overall survival (OS)
Time frame: 2 years
Blood concentrations of HRS-5041(Phase Ib)
Time frame: 16 weeks
Blood concentrations of HRS-1167(Phase Ib)
Time frame: 16 weeks
Blood concentrations of SHR2554(Phase Ib)
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Docetaxel Injection
HRS-1167 tablets
SHR2554 tablets
HRS-6208 capsules
Darolutamide Tablets
Time frame: 16 weeks
Blood concentrations of Abiraterone (Phase Ib)
Time frame: 16 weeks
Blood concentrations of HRS-6208 (Phase Ib)
Time frame: 16 weeks