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

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 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.