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The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-4602 as montherapy or in combination with other anti-tumor therapies in advanced solid tumors. To explore the reasonable dosage of SHR-4602 for advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-4602 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-4602 | Drug | SHR-4602 |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR by investigator assessment | ORR by investigator assessment was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR), Up to approximately 5 years; | Up to approximately 5 years; |
| Measure | Description | Time Frame |
|---|---|---|
| DCR by investigator assessment, | DCR by investigator assessment was defined as the percentage of participants with confirmed response (CR or PR), or SD, per RECIST v1.1 per investigator, Up to approximately 5 years; | Up to approximately 5 years; |
| DoR by investigator assessment, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fan Liang | Contact | +86 13761090346 | fan.liang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
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DoR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to the first documented PD per RECIST v1.1 per investigator or death from any cause, whichever occurs first, Up to approximately 5 years; |
| Up to approximately 5 year |
| PFS by investigator assessment, | PFS was defined as the time from date of start of study treatment to first documentation of disease progression (PD), or to death due to any cause, whichever occurred first, Up to approximately 5 years; | Up to approximately 5 years; |
| OS | OS is defined as the time from start of study treatment to death from any cause, Up to approximately 5 years; | Up to approximately 5 years; |
| Number of participants with adverse events (AEs), | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship, Up to approximately 5 years; | Up to approximately 5 years; |