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This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3821 injection in subjects with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-3821 injection | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-3821 injection | Drug | SHR-3821 injection |
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| Measure | Description | Time Frame |
|---|---|---|
| DLT | 3 weeks | |
| AE | Screening up to study completion, an average of 1 year | |
| MTD | 3 weeks | |
| RP2D | Screening up to study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Blood concentration of SHR-3821 after single and continuous administration | Screening up to study completion, an average of 1 year | |
| PK parameters of SHR-3821 after single and continuous administration: Tmax | Screening up to study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin bai | Contact | +86 15618539080 | bin.bai@hengrui.com | |
| Hao Shen | Contact | +86 021-61053363 | hao.shen@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan Hospital | Recruiting | Chengdu | Sichuan | 610000 | China |
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To evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3821 injection in subjects with advanced solid tumors.
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| PK parameters of SHR-3821 after single and continuous administration: Cmax | Screening up to study completion, an average of 1 year |
| PK parameters of SHR-3821 after single and continuous administration: AUC0-t | Screening up to study completion, an average of 1 year |
| Drug Resistant Antibody (ADA) to SHR-3821 | Screening up to study completion, an average of 1 year |
| Objective response rate (ORR) | Screening up to study completion, an average of 1 year |
| Disease control rate (DCR) | Screening up to study completion, an average of 1 year |
| Progression-free survival (PFS) | Screening up to study completion, an average of 1 year |
| Overall survival (OS) | Screening up to study completion, an average of 1 year |