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This is a Phase 1, open label, first-in-human study to evaluate safety, tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), immunogenicity and anti-tumor activity of SHR-4712 in patients with advanced solid tumors. Patients will treat with SHR-4712 until unacceptable toxicity or disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-4712 Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-4712 Injection | Drug | SHR-4712 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limited Toxicity (DLT) | First 21 days of treatment. | |
| Adverse Events (AEs) | Approximately 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to peak concentration (Tmax) | Approximately 24 months. | |
| Peak concentration (Cmax) | Approximately 24 months. | |
| Trough concentration (Ctrough) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China | ||
| Hunan Cancer Hospital |
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| Approximately 24 months. |
| Area under the concentration-time curve from time zero to the last measurable time point (AUC0-t) | Approximately 24 months. |
| Area under the concentration-time curve from time zero to infinity (AUC0-∞) | Approximately 24 months. |
| Elimination half-life (t1/2) | Approximately 24 months. |
| Apparent clearance (CL/F) | Approximately 24 months. |
| Apparent volume of distribution (Vz/F) | Approximately 24 months. |
| Objective response rate (ORR) | Approximately 24 months. |
| Duration of objective tumor response (DoR) | Approximately 24 months. |
| Disease control rate (DCR) | Approximately 24 months. |
| Progression-free survival (PFS) | Approximately 24 months. |
| Overall survival (OS) | Approximately 24 months. |
| Changsha |
| Hunan |
| 410013 |
| China |