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Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

RecruitingPhase 1Ages 18 Years - 80 YearsMaleJiangsu HengRui Medicine Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Able and willing to provide a written informed consent. 2. Age 18-80 years old, gender unlimited. 3. The physical status score of the Eastern Tumor Cooperative Group (ECOG) was 0 \~ 1. 4. Predicted survival โ‰ฅ12 weeks. 5. Histological or cytological confirmed adenocarcinoma of the prostate. 6. Patients progressed on taxane chemotherapy and at least one prior secondary hormonal therapy. Exclusion Criteria: 1. Prior treatment with an androgen receptor (AR) degrader. 2. Plan to receive any other antitumor therapy during this trial. 3. Receiving other investigational drugs or treatments that are not on the market within 4 weeks prior to the initial administration of the study. 4. Patients with known brain metastases. 5. Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness.
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What it tests

  • HRS-5041
  • Docetaxel injection
  • Abiraterone acetate tablets
  • Prednisone Acetate Tablets
  • Enzalutamide Soft Capsules
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Where

1 site
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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