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To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant Prostate Cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| : HRS-5041 dose level 1 | Experimental | 240 mg BID |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-5041 Single dose of HRS-5041 orally administered | Drug | HRS-5041 Oral dosage (Tablet) Oral dosage administration, 28 days per cycle. |
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| 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. |
| 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. |
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IInclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathy You | Contact | +61 02 9299 0433 | kathyyou@atridia.com | |
| Ravi Patel | Contact | +61 452 363 506 | ravi.patel@atridia.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GenesisCare North Shore (Oncology) | Recruiting | Sydney | New South Wales | Australia |
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| 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. |
| Sydney Adventist Hospital | Recruiting | Sydney | New South Wales | Australia |
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| Cancer Research SA | Recruiting | Adelaide | South Australia | Australia |
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| Southern Oncology Clinical Research Unit | Recruiting | Adelaide | South Australia | Australia |
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| Icon Cancer Centre South Brisbane | Recruiting | Brisbane | Australia |
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| John Flynn Private Hospital | Recruiting | Brisbane | Australia |
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| Eastern Health (Box Hill Hospital) | Recruiting | Melbourne | Australia |
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| Linear Clinical Research Ltd | Recruiting | Perth | Australia |
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| Macquarie University | Recruiting | Sydney | Australia |
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| MUPharm Pty Limited trading as Macquarie University Hospital Pharmacy | Recruiting | Sydney | Australia |
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| Illawarra Shoalhaven Local Health District (Wollongong Hospital) | Recruiting | Wollongong | Australia |
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