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

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

Study Overview

• Status: Recruiting
• Conditions: Metastatic Castration Resistant Prostate Cancer
• Intervention / Treatment: Drug: HRS-5041 Single dose of HRS-5041 orally administered

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kathy You; Phone Number: +61 02 9299 0433; Email: kathyyou@atridia.com
• Study Contact Backup: Name: Ravi Patel; Phone Number: +61 452 363 506; Email: ravi.patel@atridia.com

Study Locations

• Australia
  • Brisbane, Australia
    • Recruiting
    • Icon Cancer Centre South Brisbane
    • Principal Investigator: Jermaine Coward, Dr
  • Brisbane, Australia
    • Recruiting
    • John Flynn Private Hospital
    • Principal Investigator: David Martin, Dr
  • Melbourne, Australia
    • Recruiting
    • Eastern Health (Box Hill Hospital)
    • Principal Investigator: Ian Davis
  • Perth, Australia
    • Recruiting
    • Linear Clinical Research Ltd
    • Principal Investigator: Timothy Humphries, Dr
  • Sydney, Australia
    • Recruiting
    • Macquarie University
    • Principal Investigator: Howard Gurney
  • Sydney, Australia
    • Recruiting
    • MUPharm Pty Limited trading as Macquarie University Hospital Pharmacy
    • Principal Investigator: Howard Gurney
    • Contact: Jane Stidworthy
  • Wollongong, Australia
    • Recruiting
    • Illawarra Shoalhaven Local Health District (Wollongong Hospital)
    • Principal Investigator: Gary Tincknell, Dr
  • New South Wales
    • Sydney, New South Wales, Australia
      • Recruiting
      • GenesisCare North Shore (Oncology)
      • Principal Investigator: Ganessan Kichenadasse
    • Sydney, New South Wales, Australia
      • Recruiting
      • Sydney Adventist Hospital
      • Principal Investigator: Gavin Marx, Prof
  • South Australia
    • Adelaide, South Australia, Australia
      • Recruiting
      • Cancer Research SA
      • Contact: Sarwan Bishnoi
      • Principal Investigator: Sarwan Bishnoi
    • Adelaide, South Australia, Australia
      • Recruiting
      • Southern Oncology Clinical Research Unit
      • Principal Investigator: Ganessan Kichenadasse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: : HRS-5041 dose level 1; 240 mg BID	Drug: HRS-5041 Single dose of HRS-5041 orally administered; HRS-5041 Oral dosage (Tablet) Oral dosage administration, 28 days per cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events, ECOG PS score, vital signs (pulse rate, respiratory rate, blood pressure, body temperature), ECG, clinical chemistry, hematology, urinalysis and physical examination	To evaluate the safety and tolerability profile of HRS-5041 in subjects with mCRPC.	Screening up to study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration	Plasma concentrations of HRS-5041 during multiple dosing, directly observed from data	Screening up to study completion,an average of 1 year.
Cmax,ss	Css, max are steady-state maximum concentrations of HRS-5041during multiple dosing, and are directly observed from data.	From administration to C2, up to 4 months.
Cmin,ss	Css, min are the steady-state trough concentrations of HRS-5041 during multiple dosing, and are directly observed from data	From administration to C2, up to 4 months.
Objective Response Rate (ORR)	ORR refers to the proportion of subjects with a complete response (CR) or partial response (PR) based on all soft tissue assessments recorded from the date of first drug administration to either the date of radiographic disease progression (including bone progression and soft tissue progression), death from any cause, or the initiation of a new antitumor therapy, whichever occurs first. For subjects with CR or PR at the first evaluation, the efficacy should be confirmed 4 weeks later or at the next tumor imaging evaluation. The numerator includes subjects with a confirmed CR/PR at least 4 weeks after the initial assessment. The denominator consists of subjects with measurable target lesions at baseline.	Screening up to study completion, an average of 2 years.
Best of Response (DoR)	Best of Response (DoR) BOR refers to the best response of tumor evaluation, including CR, PR, stable disease (SD), progressive disease (PD), and not evaluable for response (NE).	Screening up to study completion, an average of 2 years.
Disease Control Rate (DCR)	Disease Control Rate (DCR) DCR refers to the time from the first occurrence of CR or PR to PD or death from any cause, whichever occurs first, in subjects with objective response. For subjects who have a confirmed CR or PR, DoR is calculated as the time from the date of first assessment confirming CR or PR to the date of first recorded radiographic disease progression or death from any cause, whichever occurs first. If the subject does not experience PD or death or is lost to follow-up at the end of study, DoR will be censored at the time of the last tumor evaluation.	Screening up to study completion, an average of 2 years.
rPFS (radiographic progression-free survival	rPFS refers to the time from the first dose of investigational drug to the first radiographic PD or death from any cause (whichever occurs first) as assessed by the investigator. Radiographic disease progression includes both bone progression (based on PCWG3 criteria) and soft tissue progression (based on RECIST v1.1 criteria), with either type of progression counting as progression.	Screening up to study completion, an average of 2 years.
PSA Response Rate at the end of Week 12	Refers to proportion of subjects with a ≥50% decline in serum PSA levels from baseline (PSA50) at the end of 12 weeks of study treatment.	Screening up to the end of Week 12 , up to 4 months.
Proportion of Subjects with PSA50 (≥ 50% decline in serum PSA from baseline)	Refers to proportion of subjects with a ≥50% decline in serum PSA levels from baseline (PSA50) throughout the study treatment period.	Screening up to the end of treatment, an average of 1 year.
Proportion of Subjects with PSA30 (≥ 30% decline in serum PSA from baseline)	Refers to proportion of subjects with a ≥30% decline in serum PSA levels from baseline (PSA30) throughout the study treatment period.	Screening up to the end of treatment, an average of 1 year.
Time to PSA Progression	Refers to time from the date of first drug administration to the date of first PSA progression. PSA progression is determined based on PCWG3 criteria.	From the date of first drug administration to the date of first PSA progression, an average of 1 year.
Overall Survival (OS)	OS refers to the time from the date of first drug administration to the date of death from any cause. From the date of first drug administration to the date of death from any cause.	From the date of first drug administration to the date of death from any cause, an average of 2 year.

Collaborators and Investigators

• Sponsor: Atridia Pty Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 15, 2027

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): February 17, 2025

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: HRS-5041-103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No