HRS-5041: HRS-5041 was given oral administration, qd, at a 28-day cycle. Patients may continue to use HRS-5041 until disease progression or unacceptable toxicity occurs.
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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 ≥12 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.
Primary outcome measure(s)
Dose-limiting toxicity (DLT) — Up to 28 days
Maximum tolerated dose (MTD) — Up to 28 days
Recommended Phase 2 Dose (RP2D) of HRS-5041 — Up to 28 days
Trial sites (1)
Facility
City
Region
Status
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai
Shanghai Municipality
Recruiting
More Jiangsu HengRui Medicine Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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