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.
Have the ability to give informed consent, and are willing and able to comply with planned visits for medical examinations and other procedural requirements.
The age is above 18 years old when signing the informed consent (the ceiling age is 80 years old in the dose escalation phase), male.
ECOG score is 0 or 1.
An expected survival of ≥ 12 weeks.
Plan to receive any other antitumor therapy during this study.
Had history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); Or had other malignancies in the 5 years prior to the first dose.
Participants who are participating in another clinical study or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or five half-lives of the investigational drug, whichever is shorter.
Had undergone major surgery within 28 days prior to first dosing; Minor traumatic surgery within 7 days prior to first dosing; There are non-healing wounds, untreated fractures.
Parallel
HRS-5041 tablets
DrugHRS-5041 tablets
Abiraterone Acetate tablets（II）
DrugAbiraterone Acetate tablets（II）
Prednisone Acetate tablets
DrugPrednisone Acetate tablets
Docetaxel Injection
DrugDocetaxel Injection
HRS-1167 tablets
DrugHRS-1167 tablets
SHR2554 tablets
DrugSHR2554 tablets
HRS-6208 capsules
DrugHRS-6208 capsules
HRS-2189 Tablets
DrugHRS-2189 tablets.
7
Treatment groupsSee each treatment group below.
Recommended phase II dose (Phase Ib)
Incidence and severity of adverse events (AE) (Phase Ib)
PSA response rate (Phase II)
Objective response rate (ORR)
Disease control rate (DCR)
Duration of response (DoR)
PSA response rate
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