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The purpose of this study is to evaluate the efficacy, and safety of HRS-5041 tablets combined with antitumor therapy in subjects with advanced prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-5041 tablets combined with Abiraterone Acetate tablets(II)and Prednisone Acetate tablets | Experimental |
| |
| HRS-5041 tablets combined with Docetaxel injection and Prednisone Acetate tablets | Experimental |
| |
| HRS-5041 tablets combined with HRS-1167 tablets | Experimental |
| |
| HRS-5041 tablets combined with SHR2554 tablets | Experimental |
| |
| HRS-5041 tablets combined with HRS-6208 capsules | Experimental |
| |
| HRS-6208 capsules combined with Abiraterone Acetate tablets(II)and Prednisone Acetate tablets | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-5041 tablets | Drug | HRS-5041 tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recommended phase II dose (Phase Ib) | 21 or 28 days | |
| Incidence and severity of adverse events (AE) (Phase Ib) | 2 years | |
| PSA response rate (Phase II) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | 1 year | |
| Disease control rate (DCR) | 1 year | |
| Duration of response (DoR) |
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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 |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150000 | China |
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HRS-5041 tablets combined with antitumor therapy
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| HRS-6208 capsules combined with Darolutamide Tablets | Experimental |
|
| Abiraterone Acetate tablets(II) | Drug | Abiraterone Acetate tablets(II) |
|
| Prednisone Acetate tablets | Drug | Prednisone Acetate tablets |
|
| Docetaxel Injection | Drug | Docetaxel Injection |
|
| HRS-1167 tablets | Drug | HRS-1167 tablets |
|
| SHR2554 tablets | Drug | SHR2554 tablets |
|
| HRS-6208 capsules | Drug | HRS-6208 capsules |
|
| Darolutamide Tablets | Drug | Darolutamide Tablets |
|
| 1 year |
| PSA response rate | 1 year |
| Time to PSA progression | 1 year |
| Radiographic progression-free survival (rPFS) | 1 year |
| Overall survival (OS) | 2 years |
| Blood concentrations of HRS-5041(Phase Ib) | 16 weeks |
| Blood concentrations of HRS-1167(Phase Ib) | 16 weeks |
| Blood concentrations of SHR2554(Phase Ib) | 16 weeks |
| Blood concentrations of Abiraterone (Phase Ib) | 16 weeks |
| Blood concentrations of HRS-6208 (Phase Ib) | 16 weeks |
| Shanghai Jiao Tong University School of Medicine, Renji Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| D000077143 | Docetaxel |
| C000607739 | darolutamide |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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