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| ID | Type | Description | Link |
|---|---|---|---|
| SHR-2002-I-102 | Other Identifier | Jiangsu Hengrui Pharmaceuticals Ltd. |
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This is Phase 1 study FIH to check "Dose Escalation, Dose expansion and Indication expansion". This study is AUSTRALIA only study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation:SHR-2002+SHR-1316 | Experimental | SHR-2002 +SHR-1316 C1D1 SHR-2002,C1D22 SHR-2002+SHR-1316, C2 SHR-2002+SHR-1316 |
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| Dose expansion stage: SHR-2002+SHR-1316 | Experimental | Dose expansion of SHR-2002 will be decided after finishing few cohorts in Dose escalation part. |
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| Indication expansion stage:SHR-2002+SHR-1316 | Experimental | Indication expansion of SHR-2002 will be decided after finishing few cohorts in Dose expansion part. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2002 and SHR-1316 | Drug | Cohort study |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of subjects with adverse events (AEs) | Screening up to study completion, an average of 2 years |
| Number of participants experiencing Dose-Limiting Toxicities (DLTs) | According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0) | Up to 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| PK of SHR-2002 + SHR-1316 | To check Maximum concentration (Cmax) | Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years |
| PK of SHR-2002 + SHR-1316 | To check AUC last |
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Subjects must meet all the following criteria to be eligible for enrollment into the study:
Subjects who meet any of the following criteria will be excluded from the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icon Cancer Centre | Brisbane | Queensland | 4101 | Australia | ||
| Linear clinical research |
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| Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years |
| Immunogenicity of SHR-2002 + SHR-1316 | ADA of SHR-2002 + SHR-1316 | Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years |
| Perth |
| Western Australia |
| 6009 |
| Australia |
| Scientia Clinical research | Sydney | 2031 | Australia |
| Liverpool Hospital | Sydney | 2170 | Australia |