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Sponsor R & D Strategy Adjustment
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The purpose of this study is to evaluate the safety of SHR-1702 monotherapy or in combination with Camrelizumab among advanced solid tumor subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A:SHR-1702 Dose Escalation | Experimental | SHR-1702 given intravenously (IV). |
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| B:SHR-1702 Dose Expansion | Experimental | SHR-1702 given intravenously (IV). |
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| C:SHR-1702 and Camrelizumab Dose Escalation | Experimental | SHR-1702 and Camrelizumab given intravenously (IV). |
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| D:SHR-1702 and Camrelizumab Dose Expansion | Experimental | SHR-1702 and Camrelizumab given intravenously (IV). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1702 | Drug | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with DLTs | Approximately 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| ORR: Percentage of Participants With a CR or PR | Approximately 2 years | |
| Safety and tolerability of SHR -1702 using Common Terminology Criteria for Adverse Events. | Dose Escalation Part -- Approximately 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
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| Camrelizumab | Drug | Administered IV |
|
| Immunogenicity as assessed by the presence of anti-drug antibodies | Approximately 2 years |
| Pharmacodynamic profile as assessed by receptor occupancy | Approximately 2 years |
| PK Parameter: Maximum Concentration (Cmax) | Approximately 2 years |
| PK Parameter: AUC, 0 to infinity | Approximately 2 years |
| PK Parameter: Clearance (CL) | Approximately 2 years |
| PK Parameter: Cmin at steady state (Cmin,ss) | Approximately 2 years |
| PK Parameter: Cmax at steady state (Cmax, ss) | Approximately 2 years |
| PK Parameter: terminal half-life (t1/2) | Approximately 2 years |