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This study is an open-label, phase I clinical trial of SHR-7631 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-7631 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-7631 | Drug | The total dosage of SHR-7631 was calculated according to the weight weighing results of the subjects before each administration, and was administered by intravenous drip. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) or maximum administered dose (MAD) | 12 months | |
| Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) (CTCAE v5.0) | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter: Tmax | 36 months | |
| PK parameter: Cmax | 36 months | |
| PK parameter: AUC0-t |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Beijing | Beijing Municipality | 100142 | China | ||
| Sun Yat-sen University Cancer Center |
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| 36 months |
| PK parameter: AUC0-∞ | 36 months |
| PK parameter: t1/2 | 36 months |
| PK parameter: MRT (mean residence time) | 36 months |
| Guangzhou |
| Guangzhou |
| 510062 |
| China |