An Open, Multicenter Phase Ib/II Study on the Safety, Tolerability and Efficacy of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer
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.
• Adenocarcinoma of the prostate confirmed with histologically or cytologically ,and without a diagnosis of neuroendocrine or small cell carcinoma.
• Adequate blood samples should be provided for gene mutation detection during the screening period. It is recommended to provide tumor tissue samples.
• Male subjects whose partner is women of childbearing potential (WOCBP) are required to use highly effective contraception from the date of signing the informed consent until 3 months after the last dose of the investigational drug.