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This is an open label, dose escalation phase I study to evaluate the clinical safety, tolerability in subjects with advanced solid tumors, and to establish the Maximum Tolerated Dose (MTD#, if any). This study is composed of two dose level: 1 and 3 mg/kg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CS1002 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS1002 | Drug | The dose levels will be escalated following a modified 3+3 dose escalation scheme. |
|
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability | Number of participants with adverse events | From the day of first dose to 21 days after last dose |
| area under the curve | (AUC)0-21d | From the time of infusion to 21 days after first dose and forth dose |
| maximum observed serum concentration (Cmax) | From the time of infusion to 21 days after first dose and forth dose |
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Inclusion Criteria:
Exclusion Criteria:
The subject must be excluded from participating in the study if the subject:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Zhengzhou | Henan | China |
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