Phase I Study of HSK46575 in Patients With Metastatic Castration-Resistant Prostate Cancer

Inclusion Criteria: 1. Male, aged ≥18 years; 2. ECOG (Eastern Cooperative Oncology Group) 0-1, expected survival of ≥ 3 months; 3. Histology or cytology confirmed adenocarcinoma of the prostate; 4. Radiological evidence of metastatic bone or soft tissue lesions; 5. Ongoing medical castration or previous surgical castration; 6. Testosterone at castration level during screening; 7. Prior to screening, subjects with evidence of disease progression while receiving ADT (androgen deprivation therapy); 8. Had progressed on at least one novel endocrine therapy, and had progressed on at least one taxane-based chemotherapy (or those who are intolerant or refuse chemotherapy); 9. The functional level of organs must meet the requirements. Exclusion Criteria: 1. Subjects with known hypersensitivity to the active ingredient or excipients of HSK46575 Tablets; 2. Subjects who have received any antitumor therapy within 4 weeks (or 5 half-lives, whichever is shorter) prior to the first dose; or treatment with nitrosoureas, bicalutamide, or nilutamide within 6 weeks (or 5 half-lives, whichever is shorter) prior to the first dose; 3. Subjects whose toxicity from prior anticancer therapy remains \> Grade 1 before the first dose; 4. Subjects who have used strong or moderate CYP3A4 inhibitors or inducers, CYP2C9 sensitive substrates, and OCT2 or MATE1 substrates within 14 days or 5 half-lives prior to the first dose of the investigational drug, whichever is longer; 5. Subjects who have undergone Grade 3-4 surgery; 6. Subjects who plan to receive any other antitumor therapy during the study ; 7. Subjects with active metastases to central nervous system; 8. Subjects with serious bone damage caused by prostate cancer bone metastasis as assessed by the investigators; 9. Within 6 months before the first dose, subjects had concurrent pituitary or adrenal dysfunction; 10. Subjects with uncontrolled hypertension; 11. Subjects with central nervous system disorders such as epilepsy and multiple sclerosis; 12. Subjects with active cardiac disease within 6 months prior to the first dose, or a history of arterial or venous thromboembolism; 13. Subjects with a QTc interval prolongation to \>470 ms during the screening period calculated by the Fridericia formula； 14. Subjects with a history of other malignancies; 15. Subjects with a history of immunodeficiency; 16. Subjects with active HBV, HCV, or syphilis infection; 17. Subjects who have participated in other clinical studies within 4 weeks before the first dose; 18. Other conditions.