RecruitingPhase 1NCT05942001

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

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

100 participants

Start Date

Aug 3, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Prostate Cancer

Summary

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: MALEMin Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

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 Criteria5

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.

Interventions

DRUGHRS-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.