A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer
NCT ID: NCT06568094
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
100 participants
INTERVENTIONAL
2024-09-25
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HRS-5041 tablets combined with Abiraterone Acetate tablets（II）and Prednisone Acetate tablets
HRS-5041 tablets
HRS-5041 tablets
Abiraterone Acetate tablets（II）
Abiraterone Acetate tablets（II）
Prednisone Acetate tablets
Prednisone Acetate tablets
HRS-5041 tablets combined with Docetaxel injection and Prednisone Acetate tablets
HRS-5041 tablets
HRS-5041 tablets
Prednisone Acetate tablets
Prednisone Acetate tablets
Docetaxel Injection
Docetaxel Injection
HRS-5041 tablets combined with HRS-1167 tablets
HRS-5041 tablets
HRS-5041 tablets
HRS-1167 tablets
HRS-1167 tablets
HRS-5041 tablets combined with SHR2554 tablets
HRS-5041 tablets
HRS-5041 tablets
SHR2554 tablets
SHR2554 tablets
Interventions
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HRS-5041 tablets
HRS-5041 tablets
Abiraterone Acetate tablets（II）
Abiraterone Acetate tablets（II）
Prednisone Acetate tablets
Prednisone Acetate tablets
Docetaxel Injection
Docetaxel Injection
HRS-1167 tablets
HRS-1167 tablets
SHR2554 tablets
SHR2554 tablets
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
MALE
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Shanghai Jiao Tong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xuedong Li
Role: primary
Wei Xue
Role: primary
Other Identifiers
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HRS-5041-201
Identifier Type: -
Identifier Source: org_study_id