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

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Jul 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called HRS-5041 for men with advanced prostate cancer that has not responded to standard treatments. The main goals of the study are to check how safe the drug is, how well it works, and to find the best dose for future research. The trial is currently recruiting participants aged 18 to 80 who have been diagnosed with prostate cancer and have already tried certain chemotherapy and hormone therapies without success.

To be eligible for this trial, participants need to be in relatively good health, meaning they should have a good performance status and be expected to live for at least 12 weeks. They should also be willing to provide written consent to join the study. However, men who have previously received specific treatments or have other serious health issues, like uncontrolled infections or significant mental health conditions, cannot participate. If you join the trial, you’ll be monitored closely for any side effects and how well the medication is working, contributing to our understanding of potential new treatments for this challenging condition.

Gender

MALE

Eligibility criteria

• 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.