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The purpose of this study is to evaluate the safety and tolerability of HRS-7525 in participants with Advanced Prostate Cancer, and to determine the dose limiting toxicity (DLT), the maximum tolerated dose (MTD, if possible), and the recommended Phase II dose (RP2D) of HRS-7525.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-7525 tablets | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7525 tablets | Drug | HRS-7525 tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| dose limiting toxicity (DLT) | a single-dose run-in period (2 days) and 21 days after the first administration of each subject | |
| the maximum tolerated dose (MTD) | From the signing of the informed consent to the end of the safety follow-up period of each subject ,about 13 months | |
| the recommended Phase II dose (RP2D) | From the signing of the informed consent to the end of the safety follow-up period of each subject ,about 13 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianpo Lian | Contact | +0518-81220121 | jianpo.lian.jl3@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Macquarie University Hospital | Sydney | New South Wales | 2109 | Australia |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ICON South Brisbane | Brisbane | Queensland | 4101 | Australia |
|
| John Flynn Private Hospital | Gold Coast | Queensland | 4224 | Australia |
|
| ICON Kurralta Park | Adelaide | South Australia | 5037 | Australia |
|
| Southern Oncology Research Uni(SOCRU) | Adelaide | South Australia | 5042 | Australia |
|
| Epworth Health | Melbourne | Victoria | 3121 | Australia |
|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |