Loading clinical trials...

RECRUITINGPHASE1

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

NCT06830850•Atridia Pty Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion 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.

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

Key Dates

Start Date

June 15, 2025

Primary Completion Date

December 30, 2026

Completion Date

March 15, 2027

Last Updated

January 15, 2026

Enrollment

ESTIMATED participants

Conditions

Metastatic Castration Resistant Prostate Cancer

Interventions

HRS-5041 Single dose of HRS-5041 orally administered

DRUG

Contacts

Kathy You

CONTACT

+61 02 9299 0433 kathyyou@atridia.com

Ravi Patel

CONTACT

+61 452 363 506 ravi.patel@atridia.com

AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)

NCT07285694

Metastatic Castration Resistant Prostate Cancer (mCRPC)

View study

RECRUITING

Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer

NCT06517719

Metastatic Castration Resistant Prostate Cancer

View study

RECRUITINGPHASE1/PHASE2

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)

Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer

Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer (mCRPC) Resistant Prostate Cancer

A Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone

Phase 1 Clinical Study of GT-220F in Subjects With Metastatic Castration Resistant Prostate Cancer (mCRPC)