A Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of HSK46575 Tablets in Patients With Metastatic Castration-Resistant Prostate Cancer
This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK（pharmacokinetics） and PD（pharmacodynamics） of HSK46575 when given orally in patients with metastatic castration-resistant prostate cancer.
• Male, aged ≥18 years;
• ECOG (Eastern Cooperative Oncology Group) 0-1, expected survival of ≥ 3 months;
• Histology or cytology confirmed adenocarcinoma of the prostate;
• Radiological evidence of metastatic bone or soft tissue lesions;
• Ongoing medical castration or previous surgical castration;
• Testosterone at castration level during screening;
• Prior to screening, subjects with evidence of disease progression while receiving ADT (androgen deprivation therapy);
• 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);
• The functional level of organs must meet the requirements.