Actively Recruiting
A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-12-31
100
Participants Needed
2
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give informed consent and willing to comply with study visits and procedures
- Male aged 18 years or older (up to 80 years in dose escalation phase)
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Confirmed adenocarcinoma of the prostate by histology or cytology, excluding neuroendocrine or small cell carcinoma
- Able to provide blood samples for gene mutation detection; tumor tissue samples recommended
- Male participants with female partners of childbearing potential must use effective contraception from consent until 3 months after last drug dose
You will not qualify if you...
- Planning to receive any other antitumor therapy during the study
- History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), or other malignancies within 5 years prior to first dose
- Participation in another clinical study with less than 4 weeks since last dose or within five half-lives of previous investigational drug
- Major surgery within 28 days or minor traumatic surgery within 7 days before first dose; presence of non-healing wounds or untreated fractures
- Use of strong CYP3A metabolic enzyme inducers or inhibitors without adequate washout period
- Unresolved toxicity from prior antitumor treatment greater than grade I
- Known central nervous system or meningeal metastasis or history of primary CNS tumors
- Severe cerebrovascular disease within 6 months prior to dosing
- Poorly controlled hypertension or history of hypertensive crisis or encephalopathy
- Severe bone injury from metastases, pathological fractures, or spinal cord compression within last 6 months or expected soon
- Conditions or diseases affecting oral drug absorption, metabolism, distribution, or excretion
- History of allergy to investigational drug or its components
- Active heart disease within 6 months prior to dosing including severe angina, myocardial infarction, symptomatic heart failure, or ventricular arrhythmias
- Active hepatitis B or C infection or serious infections requiring antimicrobial treatment
- History of immunodeficiency or organ transplantation
- Other serious physical or mental illnesses or significant laboratory abnormalities
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150000
Actively Recruiting
2
Shanghai Jiao Tong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
J
Jianpo Lian
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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