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Trial Title:
A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer
NCT ID:
NCT06568094
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Prednisone
Docetaxel
Abiraterone Acetate
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
HRS-5041 tablets combined with antitumor therapy
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HRS-5041 tablets
Description:
HRS-5041 tablets
Arm group label:
HRS-5041 tablets combined with Abiraterone Acetate tablets（II）and Prednisone Acetate tablets
Arm group label:
HRS-5041 tablets combined with Docetaxel injection and Prednisone Acetate tablets
Arm group label:
HRS-5041 tablets combined with HRS-1167 tablets
Arm group label:
HRS-5041 tablets combined with SHR2554 tablets
Intervention type:
Drug
Intervention name:
Abiraterone Acetate tablets（II）
Description:
Abiraterone Acetate tablets（II）
Arm group label:
HRS-5041 tablets combined with Abiraterone Acetate tablets（II）and Prednisone Acetate tablets
Intervention type:
Drug
Intervention name:
Prednisone Acetate tablets
Description:
Prednisone Acetate tablets
Arm group label:
HRS-5041 tablets combined with Abiraterone Acetate tablets（II）and Prednisone Acetate tablets
Arm group label:
HRS-5041 tablets combined with Docetaxel injection and Prednisone Acetate tablets
Intervention type:
Drug
Intervention name:
Docetaxel Injection
Description:
Docetaxel Injection
Arm group label:
HRS-5041 tablets combined with Docetaxel injection and Prednisone Acetate tablets
Intervention type:
Drug
Intervention name:
HRS-1167 tablets
Description:
HRS-1167 tablets
Arm group label:
HRS-5041 tablets combined with HRS-1167 tablets
Intervention type:
Drug
Intervention name:
SHR2554 tablets
Description:
SHR2554 tablets
Arm group label:
HRS-5041 tablets combined with SHR2554 tablets
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affiliated Hospital of Harbin Medical University
Address:
City:
Ha'erbin
Zip:
150000
Country:
China
Status:
Recruiting
Contact:
Last name:
Wanhai Xu
Facility:
Name:
Shanghai Jiao Tong University School of Medicine, Renji Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Xue
Start date:
September 6, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Jiangsu HengRui Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06568094
