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The study is being conducted to evaluate the pharmacokinetics , safety, tolerability and efficacy in patients with solid tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-Dose Group | Experimental |
| |
| Medium-Dose Group | Experimental |
| |
| High-Dose Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1811 Subcutaneous Injection | Drug | SHR-A1811 subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from time zero to 21 days (AUC0-21d) of SHR-A1811(sc) | About 72 weeks. | |
| The incidence and severity of Dose-Limiting Toxicities (DLTs) | About 72 weeks. | |
| Adverse Events (AEs) | About 72 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum concentration (Tmax) | About 72 weeks. | |
| Maximum concentration (Cmax) | About 72 weeks. | |
| Trough concentration (Cmin) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yue Zhang | Contact | +86-0518-82342973 | yue.zhang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| SHR-A1811 for Injection | Drug | SHR-A1811 for injection. |
|
| About 72 weeks. |
| Area under the concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t) | About 72 weeks. |
| Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) | About 72 weeks. |
| Elimination half-life (t1/2) | About 72 weeks. |
| Mean residence time (MRT) | About 72 weeks. |
| Apparent clearance (CL/F) | About 72 weeks. |
| Apparent volume of distribution at steady state (Vss/F) | About 72 weeks. |
| Area under the concentration-time curve at steady state (AUCss) | About 72 weeks. |
| Maximum concentration at steady state (Css, max) | About 72 weeks. |
| Trough concentration at steady state (Css, min) | About 72 weeks. |
| Accumulation ratio (Rac) | About 72 weeks. |
| Anti-SHR-A1811 antibodies (ADA) | About 72 weeks. |
| Objective Response Rate (ORR) | About 72 weeks. |
| Duration of Response (DoR) | About 72 weeks. |
| Disease Control Rate (DCR) | About 72 weeks. |
| Progression-Free Survival (PFS) | About 72 weeks. |
| Overall Survival (OS) | About 72 weeks. |