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

Last updated: January 13, 2026
Sponsor: Atridia Pty Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Urologic Cancer

Prostate Cancer

Prostate Disorders

Treatment

HRS-5041 Single dose of HRS-5041 orally administered

Clinical Study ID

NCT06830850
HRS-5041-103
  • Ages > 18
  • Male

Study Summary

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

Eligibility Criteria

Inclusion

IInclusion Criteria

  1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.

  2. Adequate bone marrow and other vital organ functions

  3. Adequate liver function tests

  4. Metastatic Castration-resistant Prostate Cancer

Exclusion Criteria

  1. Plan to receive any other anti-tumor therapy during the study.

  2. Receipt of any chemotherapy, targeted therapy, immunotherapy, live/attenuated vaccination, radiotherapy or surgery within 4 weeks prior to the first dosing of this study.

  3. Uncontrolled hypertension (systolic blood pressure [SBP] > 150 mmHg and/or diastolic blood pressure [DBP] > 100 mmHg with regular anti-hypertension therapy).

  4. Factors that may affect the oral administration of the IP (swallow difficulty, chronic diarrhea, and bowel obstruction, etc.), or active gastrointestinal (GI) disease or other disease which may affect the absorption, distribution, metabolism, or elimination of IP.

  5. Known history of drug allergies, specific allergies (such as asthma, urticaria, eczema, etc.).

  6. Active heart disease within 6 months prior to the first dosing of this study.

  7. Medical history of other malignant tumor within 5 years prior to dosing.

  8. Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV-Ab), or syphilis or severe infections which need treatment.

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: HRS-5041 Single dose of HRS-5041 orally administered
Phase: 1
Study Start date:
June 15, 2025
Estimated Completion Date:
March 15, 2027

Connect with a study center

  • Blacktown Hospital

    Sydney, New South Wales
    Australia

    Site Not Available

  • GenesisCare North Shore (Oncology)

    Sydney, New South Wales
    Australia

    Site Not Available

  • Sydney Adventist Hospital

    Sydney, New South Wales
    Australia

    Site Not Available

  • GenesisCare North Shore (Oncology)

    Sydney 2147714, New South Wales 2155400
    Australia

    Active - Recruiting

  • Sydney Adventist Hospital

    Sydney 2147714, New South Wales 2155400
    Australia

    Active - Recruiting

  • Cancer Research SA

    Adelaide, South Australia
    Australia

    Active - Recruiting

  • Southern Oncology Clinical Research Unit

    Adelaide, South Australia
    Australia

    Site Not Available

  • Cancer Research SA

    Adelaide 2078025, South Australia 2061327
    Australia

    Active - Recruiting

  • Southern Oncology Clinical Research Unit

    Adelaide 2078025, South Australia 2061327
    Australia

    Active - Recruiting

  • Icon Cancer Centre South Brisbane

    Brisbane,
    Australia

    Active - Recruiting

  • John Flynn Private Hospital

    Brisbane,
    Australia

    Site Not Available

  • Icon Cancer Centre South Brisbane

    Brisbane 2174003,
    Australia

    Active - Recruiting

  • John Flynn Private Hospital

    Brisbane 2174003,
    Australia

    Active - Recruiting

  • Eastern Health (Box Hill Hospital)

    Melbourne,
    Australia

    Site Not Available

  • Eastern Health (Box Hill Hospital)

    Melbourne 2158177,
    Australia

    Active - Recruiting

  • Linear Clinical Research Ltd

    Perth,
    Australia

    Site Not Available

  • Linear Clinical Research Ltd

    Perth 2063523,
    Australia

    Active - Recruiting

  • MUPharm Pty Limited trading as Macquarie University Hospital Pharmacy

    Sydney,
    Australia

    Site Not Available

  • Macquarie University

    Sydney,
    Australia

    Site Not Available

  • MUPharm Pty Limited trading as Macquarie University Hospital Pharmacy

    Sydney 2147714,
    Australia

    Active - Recruiting

  • Macquarie University

    Sydney 2147714,
    Australia

    Active - Recruiting

  • Illawarra Shoalhaven Local Health District (Wollongong Hospital)

    Wollongong,
    Australia

    Site Not Available

  • Illawarra Shoalhaven Local Health District (Wollongong Hospital)

    Wollongong 2171507,
    Australia

    Active - Recruiting

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