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

Plain Language Summary

Simplified for easier understanding

This study is testing HRS-5041, a new drug targeting a protein called PSMA (found on prostate cancer cells), for men with metastatic castration-resistant prostate cancer (mCRPC) — meaning the cancer has spread and is no longer responding to standard hormone therapy. **You may be eligible if...** - You are between 18 and 80 years old - You have prostate cancer confirmed by biopsy (adenocarcinoma) - Your cancer has spread to other parts of the body and is no longer controlled by hormone treatment (castration-resistant) - You have a PSMA-positive tumor confirmed by imaging - You are in good enough health (ECOG 0–1) with at least 12 weeks of expected survival **You may NOT be eligible if...** - You have small cell or neuroendocrine prostate cancer - You have already received certain prior treatments that are not permitted by the study - You have active brain metastases - You have serious organ dysfunction or active serious infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.