Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jiangsu HengRui Medicine Co., Ltd.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
1. Ability to understand and the willingness to sign a written informed consent document；
2. Age ≥18 years old;
3. Histologically or cytologically confirmed prostate adenocarcinoma;
4. Candidate for androgen deprivation therapy (ADT) for the management of hormone-sensitive prostate cancer；
5. Appropriate serum testosterone and serum PSA concentration at screening as specified in the protocol；
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
7. Adequate organ performance based on laboratory blood tests;
8. Agree to use adequate contraception prior to study entry and for the duration of study participation.
You may not be if
1. 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).
2. Patients who have received chemotherapy for prostate cancer;
3. History of surgical castration;
4. Received Abiraterone acetate with 3 months prior to the first dose of study drug;
5. 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;
6. Patients with known or suspected brain metastasis；
7. Diagnosis or treatment for another systemic malignancy within 5 years before study treatment initiation;
8. Patients with uncontrolled and clinically significant hypertension and diabetes;
9. Known hypersensitivity to SHR7280, SHR7280 excipients,；
10. History of immunodeficiency (including HIV infection) or organ transplantation;
11. Known active hepatitis B or C infection;
12. Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
Clareo Health | A Phase 1 Dose Escalation and Expansion Study Of SHR7280 In Subjects With Hormone Sensitive Prostate Cancer
