Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Recruiting · NCT05942001 · Interventional (participants receive a specific treatment) · Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
Abiraterone acetate tabletsDocetaxel injectionEnzalutamide Soft CapsulesHRS-5041Prednisone Acetate Tablets
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
- Patients with known brain metastases.
- Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness.
Where it is running
1 location listed.
- Shanghai Jiaotong University School of Medicine, Renji Hospital - Shanghai, Shanghai Municipality, China