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

Phase 1

Not yet recruiting

• Conditions: Metastatic Castration Resistant Prostate Cancer
• Interventions: Drug: HRS-5041 Single dose of HRS-5041 orally administered

• Registration Number: NCT06830850
• Lead Sponsor: Atridia Pty Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-12
• Study First Submitted QC: 2025-02-12
• Study First Posted: 2025-02-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-16
• Study Start: 2025-06-15
• Primary Completion: 2026-12-30
• Study Completion: 2027-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
: HRS-5041 dose level 1	HRS-5041 Single dose of HRS-5041 orally administered	240 mg BID

Primary Outcome Measures

Name	Time	Method
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	Screening up to study completion, an average of 1 year.	To evaluate the safety and tolerability profile of HRS-5041 in subjects with mCRPC.

Secondary Outcome Measures

Name	Time	Method
Cmin,ss	From administration to C2, up to 4 months.	Css, min are the steady-state trough concentrations of HRS-5041 during multiple dosing, and are directly observed from data
Concentration	Screening up to study completion,an average of 1 year.	Plasma concentrations of HRS-5041 during multiple dosing, directly observed from data
Cmax,ss	From administration to C2, up to 4 months.	Css, max are steady-state maximum concentrations of HRS-5041during multiple dosing, and are directly observed from data.
Objective Response Rate (ORR)	Screening up to study completion, an average of 2 years.	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.
Best of Response (DoR)	Screening up to study completion, an average of 2 years.	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).
Disease Control Rate (DCR)	Screening up to study completion, an average of 2 years.	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.
rPFS (radiographic progression-free survival	Screening up to study completion, an average of 2 years.	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.
PSA Response Rate at the end of Week 12	Screening up to the end of Week 12 , up to 4 months.	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.
Proportion of Subjects with PSA50 (≥ 50% decline in serum PSA from baseline)	Screening up to the end of treatment, an average of 1 year.	Refers to proportion of subjects with a ≥50% decline in serum PSA levels from baseline (PSA50) throughout the study treatment period.
Proportion of Subjects with PSA30 (≥ 30% decline in serum PSA from baseline)	Screening up to the end of treatment, an average of 1 year.	Refers to proportion of subjects with a ≥30% decline in serum PSA levels from baseline (PSA30) throughout the study treatment period.
Time to PSA Progression	From the date of first drug administration to the date of first PSA progression, an average of 1 year.	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.
Overall Survival (OS)	From the date of first drug administration to the date of death from any cause, an average of 2 year.	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.

Trial Locations

Locations (11)

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

Illawarra Shoalhaven Local Health District (Wollongong Hospital); 🇦🇺 Wollongong, Australia

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