A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-7525 Tablets in Patients With Advanced Prostate Cancer
The purpose of this study is to evaluate the safety and tolerability of HRS-7525 in participants with Advanced Prostate Cancer, and to determine the dose limiting toxicity (DLT), the maximum tolerated dose (MTD, if possible), and the recommended Phase II dose (RP2D) of HRS-7525.
• Voluntarily participating in this clinical study, understanding the study procedures, and being able to provide written informed consent;
• Males, aged 18-80 years (inclusive; no upper age limit in the expansion stage);
• Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-1;
• Life expectancy ≥12 weeks;
• Histologically or cytologically confirmed adenocarcinoma of the prostate, without a diagnosis of neuroendocrine carcinoma or small cell carcinoma;
• Presence of metastatic lesions confirmed by CT/MRI or radionuclide bone scan (99mTc);
• Male participants with a female partner of childbearing potential must agree to refrain from sperm donation and use appropriate contraceptive measures from the time of signing the informed consent form until 3 months after the last dose of the investigational product；