RecruitingPhase 1NCT06830850

A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer

A Phase I, Open-label, Multi-Center, Non-Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer


Sponsor

Atridia Pty Ltd.

Enrollment

25 participants

Start Date

Jun 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant Prostate Cancer.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new oral drug called HRS-5041 in men with metastatic castration-resistant prostate cancer — meaning prostate cancer that has spread to other parts of the body and no longer responds to hormone therapy. The study is evaluating the drug's safety, how the body processes it, and whether it helps fight the cancer. **You may be eligible if...** - You have been diagnosed with metastatic castration-resistant prostate cancer - Your blood counts, kidney, and liver function are adequate - You are willing and able to understand the study and its possible side effects **You may NOT be eligible if...** - You plan to receive any other anti-cancer treatment during the study - You have received chemotherapy, radiation, immunotherapy, or surgery within 4 weeks of starting the study - You have uncontrolled high blood pressure - You have difficulty swallowing or chronic digestive problems that could affect how the drug is absorbed 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 Single dose of HRS-5041 orally administered

HRS-5041 Oral dosage (Tablet) Oral dosage administration, 28 days per cycle.


Locations(11)

GenesisCare North Shore (Oncology)

Sydney, New South Wales, Australia

Sydney Adventist Hospital

Sydney, New South Wales, Australia

Cancer Research SA

Adelaide, South Australia, Australia

Southern Oncology Clinical Research Unit

Adelaide, South Australia, Australia

Icon Cancer Centre South Brisbane

Brisbane, Australia

John Flynn Private Hospital

Brisbane, Australia

Eastern Health (Box Hill Hospital)

Melbourne, Australia

Linear Clinical Research Ltd

Perth, Australia

Macquarie University

Sydney, Australia

MUPharm Pty Limited trading as Macquarie University Hospital Pharmacy

Sydney, Australia

Illawarra Shoalhaven Local Health District (Wollongong Hospital)

Wollongong, Australia

View Full Details on ClinicalTrials.gov

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NCT06830850


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