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This is a phase II, multicentre clinical study investigating HS-20093 or SHR2554 in combination with a Novel Hormonal Agent (NHA) for advanced prostate cancer. The trial comprises two cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 Group | Experimental |
| |
| Cohort 2 Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-20093 for Injection | Drug | HS-20093 for injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: 6-month undetectable Prostate Specific Antigen (PSA) rate. | 6 months. | |
| Cohort 2: Prostate Specific Antigen (PSA) response rate. | About 2 years. | |
| Cohort 2: Adverse events (AEs). | About 2 years. | |
| Cohort 2: Dose-limiting toxicity (DLT). | About 28 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Progression-Free Survival (rPFS). | About 2 years. | |
| Time to Prostate Specific Antigen (PSA) progression. | About 2 years. | |
| Time to Next Symptomatic Skeletal Event (SSE). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenliang Wang | Contact | +86-0518-82342973 | wenliang.wang@hengrui.com | |
| Qi Zhang | Contact | +86-021-60453139 | qi.zhang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | 210009 | China |
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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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| ID | Term |
|---|---|
| D007267 | Injections |
| C089740 | abiraterone |
| C540278 | enzalutamide |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| SHR3680 Tablet |
| Drug |
SHR3680 tablet. |
|
| Abiraterone Tablet | Drug | Abiraterone tablet. |
|
| SHR2554 Tablet | Drug | SHR2554 tablet. |
|
| Enzalutamide Tablet | Drug | Enzalutamide tablet. |
|
| Darotamine Capsule | Drug | Darotamine capsule. |
|
| About 2 years. |
| Time to Next Antineoplastic Therapy (TTNT). | About 2 years. |
| Objective response rate (ORR). | About 2 years. |
| Cohort 1: Adverse events (AEs). | About 2 years. |
| Disease control rate (DCR). | About 2 years. |
| Duration of response (DoR). | About 2 years. |
| Overall Survival (OS). | About 2 years. |
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |