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

Launched by ATRIDIA PTY LTD. · Feb 12, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to test a new medication called HRS-5041 for men who have metastatic castration-resistant prostate cancer, which means their cancer has spread and is no longer responding to standard hormone treatments. Researchers want to find out if this medication is safe, how well it works, and how it is processed in the body. The trial is currently not recruiting participants, but it will be open to men aged 65 to 74 who meet specific health criteria.

To join the trial, participants must be able to understand the study and give their consent, have good functioning of their vital organs, and have a confirmed diagnosis of metastatic castration-resistant prostate cancer. However, individuals who plan to receive other cancer treatments during the study or have certain health issues, like uncontrolled high blood pressure or recent heart disease, may not be eligible. Participants will take the medication and will be monitored for any side effects and how their bodies respond to the treatment. This trial is an important step in exploring new options for men facing this challenging condition.

Gender

MALE

Eligibility criteria

• • 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.