Actively Recruiting

Phase 1
Age: 18Years +
MALE
NCT06830850

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

Led by Atridia Pty Ltd. · Updated on 2026-01-15

25

Participants Needed

11

Research Sites

91 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand the trial procedures and possible adverse events and voluntarily participate in the trial
  • Adequate bone marrow and other vital organ functions
  • Adequate liver function tests
  • Diagnosis of metastatic castration-resistant prostate cancer
Not Eligible

You will not qualify if you...

  • Planning to receive any other anti-tumor therapy during the study
  • Received chemotherapy, targeted therapy, immunotherapy, live/attenuated vaccination, radiotherapy, or surgery within 4 weeks prior to first dosing
  • Uncontrolled hypertension (SBP > 150 mmHg and/or DBP > 100 mmHg despite treatment)
  • Conditions affecting oral administration or absorption of the investigational product such as swallowing difficulties, chronic diarrhea, bowel obstruction, or active gastrointestinal disease
  • Known history of drug allergies or specific allergies like asthma, urticaria, or eczema
  • Active heart disease within 6 months prior to first dosing
  • History of other malignant tumors within 5 years prior to dosing
  • Positive tests for hepatitis B virus, hepatitis C virus, syphilis, or severe infections needing treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 11 locations

1

GenesisCare North Shore (Oncology)

Sydney, New South Wales, Australia

Actively Recruiting

2

Sydney Adventist Hospital

Sydney, New South Wales, Australia

Actively Recruiting

3

Cancer Research SA

Adelaide, South Australia, Australia

Actively Recruiting

4

Southern Oncology Clinical Research Unit

Adelaide, South Australia, Australia

Actively Recruiting

5

Icon Cancer Centre South Brisbane

Brisbane, Australia

Actively Recruiting

6

John Flynn Private Hospital

Brisbane, Australia

Actively Recruiting

7

Eastern Health (Box Hill Hospital)

Melbourne, Australia

Actively Recruiting

8

Linear Clinical Research Ltd

Perth, Australia

Actively Recruiting

9

Macquarie University

Sydney, Australia

Actively Recruiting

10

MUPharm Pty Limited trading as Macquarie University Hospital Pharmacy

Sydney, Australia

Actively Recruiting

11

Illawarra Shoalhaven Local Health District (Wollongong Hospital)

Wollongong, Australia

Actively Recruiting

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Research Team

K

Kathy You

CONTACT

R

Ravi Patel

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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