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This is an open label, multi-center, multiple doses Phase I/II study to evaluate the safety, tolerability ,pharmacokinetics and efficacy of SHR-9803 for injection in subjects with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-9803 | Experimental | SHR-9803 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-9803 | Drug | SHR-9803 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limited Toxicity(Ia) | Screening up to the end of phase Ia, an average of 6 months | |
| Dose Limited Toxicity (Ib) | Screening up to the end of phase Ib, an average of 1 year | |
| Recommended phase II dose(Ib) | Screening up to the end of phase Ib, an average of 2 years | |
| objective response rate(II) | Screening up to study completion, an average of 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events, | Screening up to study completion, an average of 3 year; | |
| Disease Control Rate (DCR), | Screening up to study completion, an average of 3 year | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weixia Li | Contact | +86 021-61053363 | weixia.li@hengrui.com | |
| Yang Wang | Contact | +86 021-61053363 | yang.wang.yw263@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbin Medical University cancer hospital | Harbin | Heilongjiang | 150081 | China |
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| Progression-Free Survival (PFS), |
| Screening up to study completion, an average of 3 year; |
| Plasma concentration of SHR-9803 | Screening up to study completion, an average of 3 year; |