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An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 (BRAF V600E Inhibitor) in Advanced Solid Tumor With BRAF V600 Mutation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLX208 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLX208 | Drug | 900mg bid po |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate(assessed by independent radiological review committee (IRRC) based on the e RECIST Version 1.1) | from first dose to the last patient was followed up for 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-free survival(PFS):assessed by IRRC and the investigator based on the RECIST Version 1.1 | [Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)ļ¼assessed up to 1 years] |
| DOR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohua Wu, PhD | Contact | 021-34778299 | Wu.xh@fudan.edu.cn |
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Duration of response |
| [Time Frame: from the first occurrence of a documented CR or PR (whichever recorded earlier) to the time of first documented disease progression or death (whichever occurs first) assessed up to 1 years] |
| OS | Overall survival | [Time Frame: from the first dose to the time of death due to any causeļ¼assessed up to 2 years] |