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The study is being conducted to evaluate the safety and tolerability of SHR-4506 Injection in patients with malignant tumors and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-4506 Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-4506 Injection | Drug | SHR-4506 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limited Toxicities (DLTs) | Up to 21 days. | |
| Maximum Tolerated Dose (MTD) | Up to 21 days. | |
| Incidence and severity of adverse events (AEs) | Up to 90 days after the last dose. | |
| Incidence and severity of serious adverse events (SAEs) | Up to 90 days after the last dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) assessed by the investigator | Up to 3 years. | |
| Objective tumor response duration (DoR) | Up to 3 years. | |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Shen | Contact | +86-0518-81220121 | jie.shen@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| Up to 3 years. |
| Progression free survival (PFS) | Up to 3 years. |
| Overall survival (OS) | Up to 3 years. |
| Renji Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
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