A Phase 1 Dose Escalation and Expansion Study Of SHR7280 In Subjects With Hormone Sensitive Prostate Cancer

Inclusion criteria

• Ability to understand and the willingness to sign a written informed consent document；
• Age ≥18 years old;
• Histologically or cytologically confirmed prostate adenocarcinoma;
• Candidate for androgen deprivation therapy (ADT) for the management of hormone-sensitive prostate cancer；
• Appropriate serum testosterone and serum PSA concentration at screening as specified in the protocol；
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
• Adequate organ performance based on laboratory blood tests;
• Agree to use adequate contraception prior to study entry and for the duration of study participation.

Exclusion criteria

• Previously received gonadotropin-releasing hormone analogues (GnRH-a) for more than 12 months total duration (if GnRH-a was received for 12 months or less, then that GnRH-a must have been completed washout period prior to the first dose of study drug).
• Patients who have received chemotherapy for prostate cancer;
• History of surgical castration;
• Received Abiraterone acetate with 3 months prior to the first dose of study drug;
• Receieved molecular target therapy, immunotherapy, androgen receptor blockade, 5-alpha reductase inhibitors, estrogen, and other investigational compound with 4 weeks prior to the first dose of study drug;
• Patients with known or suspected brain metastasis；
• Diagnosis or treatment for another systemic malignancy within 5 years before study treatment initiation;
• Patients with uncontrolled and clinically significant hypertension and diabetes;
• Known hypersensitivity to SHR7280, SHR7280 excipients,；
• History of immunodeficiency (including HIV infection) or organ transplantation;
• Known active hepatitis B or C infection;
• Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.