Prostate Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy, and safety of HRS-5041 tablets combined with antitumor therapy in subjects with advanced prostate cancer.
Interventions
DRUGHRS-5041 tablets
HRS-5041 tablets
Abiraterone Acetate tablets（II）
Prednisone Acetate tablets
DRUGDocetaxel Injection
Docetaxel Injection
DRUGHRS-1167 tablets
HRS-1167 tablets
DRUGSHR2554 tablets
SHR2554 tablets
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
HRS-5041 tablets combined with antitumor therapy
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Have the ability to give informed consent, and are willing and able to comply with planned visits for medical examinations and other procedural requirements. 2. The age is above 18 years old when signing the informed consent (the ceiling age is 80 years old in the dose escalation phase), male. 3. ECOG score is 0 or 1. 4. An expected survival of ≥ 12 weeks. 5. Adenocarcinoma of the prostate confirmed with histologically or cytologically ,and without a diagnosis of neuroendocrine or small cell carcinoma. 6. Adequate blood samples should be provided for gene mutation detection during the screening period. It is recommended to provide tumor tissue samples. 7. Male subjects whose partner is women of childbearing potential (WOCBP) are required to use highly effective contraception from the date of signing the informed consent until 3 months after the last dose of the investigational drug.
Exclusion criteria
1. Plan to receive any other antitumor therapy during this study. 2. Had history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); Or had other malignancies in the 5 years prior to the first dose. 3. Participants who are participating in another clinical study or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or five half-lives of the investigational drug, whichever is shorter. 4. Had undergone major surgery within 28 days prior to first dosing; Minor traumatic surgery within 7 days prior to first dosing; There are non-healing wounds, untreated fractures. 5. Drugs with a strong inducer or inhibitor of the metabolic enzyme CYP3A have been used in the past, and the washout period from the end time to the first administration in this study is shorter than the 5 half-life of the drug. 6. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I. 7. Central nervous system or meningeal metastasis of tumors is known or subjects have a history of primary central nervous system tumors. 8. Severe cerebrovascular disease occurred within 6 months prior to administration. 9. Subjects with poorly controlled hypertension and a history of hypertensive crisis or hypertensive encephalopathy. 10. Severe bone injury due to bone metastases, pathological fractures , and spinal cord compression as determined by the investigators at important sites that occurred within the last 6 months or are expected to occur in the near future. 11. Having one of multiple factors that affect the oral drug or having an active gastrointestinal disease or other disease that may significantly affect drug absorption, distribution, metabolism, or excretion. 12. Had history of allergy to the proposed investigational drug or its excipient components. 13. Presence of active heart disease in the 6 months prior to first dosing, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and medically treatable ventricular arrhythmias. 14. Presence of active hepatitis B and hepatitis C; Or serious infected persons requiring antibiotics, antivirals or antifungal drugs to control. 15. Presence of the history of immunodeficiency or organ transplantation. 16. Presence of other serious physical or mental diseases or laboratory abnormalities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recommended phase II dose (Phase Ib) | 21 or 28 days |
| Incidence and severity of adverse events (AE) (Phase Ib) | 2 years |
| PSA response rate (Phase II) | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) | 1 year |
| Disease control rate (DCR) | 1 year |
| Duration of response (DoR) | 1 year |
| PSA response rate | 1 year |
| Blood concentrations of HRS-1167(Phase Ib) | 16 weeks |
| Radiographic progression-free survival (rPFS) | 1 year |
| Overall survival (OS) | 2 years |
| Blood concentrations of HRS-5041(Phase Ib) | 16 weeks |
| Time to PSA progression | 1 year |
| Blood concentrations of SHR2554(Phase Ib) | 16 weeks |
| Blood concentrations of Abiraterone (Phase Ib) | 16 weeks |
Countries
China
Contacts
Primary ContactJianpo Lian
Outcome results
None listed