Tests HRS-5041 in men with advanced prostate cancer that stopped responding to hormone therapy
Tests HRS-5041, a new drug, in men with advanced, spreading prostate cancer.
Plain-language title generated from the registry record
Registry title: Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05942001, who can take part
Where in China
- Shanghai Jiaotong University School of Medicine, Renji HospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jiangsu HengRui Medicine Co., Ltd.
- Trial code
- NCT05942001
- Record updated
- 31 August 2026
- Original description
The purpose of this study is to assess the safety, tolerability and preliminary efficacy of HRS-5041 in men with progressive metastatic castration resistant prostate cancer. The objective of this study was to determine the dose-limiting toxicity, maximum tolerance and recommended dose of HRS-5041 in phase II study.Read full original descriptionShow less
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer
The purpose of this study is to assess the safety, tolerability and preliminary efficacy of HRS-5041 in men with progressive metastatic castration resistant prostate cancer. The objective of this study was to determine the dose-limiting toxicity, maximum tolerance and recommended dose of HRS-5041 in phase II study.
Inclusion: Able and willing to provide a written informed consent; Age 18-80 years old, gender unlimited; The physical status score of the Eastern Tumor Cooperative Group (ECOG) was 0 ~ 1; Predicted survival ≥12 weeks; Histological or cytological confirmed adenocarcinoma of the prostate; Patients progressed on taxane chemotherapy and at least one prior secondary hormonal therapy.
Exclusion: Prior treatment with an androgen receptor (AR) degrader; Plan to receive any other antitumor therapy during this trial; Receiving other investigational drugs or treatments that are not on the market within 4 weeks prior to the initial administration of the study; Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness; Patients with known brain metastases.