RecruitingPhase 1Phase 2NCT06568094

A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer

An Open, Multicenter Phase Ib/II Study on the Safety, Tolerability and Efficacy of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

100 participants

Start Date

Sep 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the efficacy, and safety of HRS-5041 tablets combined with antitumor therapy in subjects with advanced prostate cancer.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new investigational tablet called HRS-5041 in men with advanced prostate cancer. It is being combined with other anti-cancer therapies to see if it is safe and effective for treating prostate cancer that has continued to grow despite standard treatments. **You may be eligible if:** - You are a man aged 18 to 80 years (or any age above 18 in later phases) - You have histologically confirmed prostate adenocarcinoma (a specific type of prostate cancer) - You have good general health (ECOG score 0 or 1) and expected survival of at least 12 weeks - Your organ function is adequate for trial participation - Your partner uses reliable contraception if she can become pregnant **You may NOT be eligible if:** - You are currently receiving or planning to receive another anti-cancer treatment during this study - You have neuroendocrine or small cell prostate cancer (a more aggressive subtype) - Your general health is too poor to tolerate study treatment 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 tablets

HRS-5041 tablets

DRUGAbiraterone Acetate tablets(II)

Abiraterone Acetate tablets(II)

DRUGPrednisone Acetate tablets

Prednisone Acetate tablets

DRUGDocetaxel Injection

Docetaxel Injection

DRUGHRS-1167 tablets

HRS-1167 tablets

DRUGSHR2554 tablets

SHR2554 tablets


Locations(2)

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Shanghai Jiao Tong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06568094


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