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The study is being conducted to evaluate the efficacy, andsafety of HRS-6209in subjects with advanced solid tumors.To explore the reasonable dosage of HRS-6209.This study also preliminarily evaluated the efficacy of HRS-6209 in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-6209 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-6209 | Drug | HRS-6209 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints: Number of subjects with adverse events and the severity of adverse events | every 4 weeks after treatment initiation,up to approximately 2 years. | |
| DLT(Dose-limiting toxicity) | during the first 30-day cycle of SHR-6209 treatment | |
| MTD(Maximum tolerated dose) | 4 weeks after treatment initiation | |
| RP2D(Recommended Phase II Dose) | 4 weeks after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| ORR(Objective response rate (ORR) - RECIST 1.1 | ORR is defined as the proportion of subjects who have achieved complete response (CR) or partial response (PR) according to RECIST 1.1) | Up to approximately 6 months |
| DoR(Duration of Response (DoR)Duration of Response (DoR) per RECIST 1.1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center- | Shanghai | Shanghai Municipality | 201321 | China |
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| Up to approximately 2 years |
| DCR(Disease control rate(DCR)-RECIST 1.1 | DCR is defined as the proportion of subjects who have achieved Stable disease(SD)、complete response (CR) or partial response (PR) according to RECIST 1.1) | Up to approximately 2 years |
| PFS-Progression-free survival(PFS) PFS per RECIST 1.1 | Up to approximately 2 years |