RecruitingPhase 1Phase 2NCT06689163

A Study for the Treatment of Metastatic Prostate Cancer With HRS-1167 Tablets Combined With Abiraterone Acetate Tablets and Prednisone

An Open, Multicenter Phase Ib/II Study for the Treatment of Metastatic Prostate Cancer With HRS-1167 Tablets Combined With Abiraterone Acetate Tablets and Prednisone


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

66 participants

Start Date

Dec 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study was to observe and evaluate the tolerability, safety, and pharmacokinetics of HRS-1167 combined with abiraterone acetate tablets (II) and prednisone in patients with metastatic prostate cancer, determine the RP2D, and evaluate the effectiveness.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment for men with prostate cancer that has spread to other parts of the body (metastatic prostate cancer). It is evaluating a new drug called HRS-1167 used together with abiraterone acetate and prednisone — a standard hormone-blocking combination — to see if adding HRS-1167 improves outcomes. **You may be eligible if...** - You are male, 18 or older - You have been diagnosed with metastatic prostate cancer confirmed by biopsy - Your cancer has been confirmed to have spread (seen on scans) - You have a good general health status (ECOG 0–1) - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - You have received prior systemic treatment for prostate cancer in certain contexts (eligibility depends on the specific study stage) - You have significant heart, liver, or kidney problems - You are unwilling to use contraception if your partner could become pregnant 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-1167 tablets

HRS-1167 tablets

DRUGAbiraterone Acetate tablets(II)

Abiraterone Acetate tablets(II)

DRUGPrednisone Acetate tablets

Prednisone Acetate tablets


Locations(2)

The First Affiliated Hospital Of Anhui Medical University

Hefei, Anhui, China

Hunan Cancer Hospital

Changsha, Hunan, China

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NCT06689163


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