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An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for advanced melanoma with BRAF V600 mutation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose-escalation stage | Experimental | Iinvestigate the safety and determine the MTD of HLX208. Two dose levels of 600mg and 900 mg are planned for dose finding. |
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| Dose-expansion stage | Experimental | Patients with advanced melanoma will be enrolled in two expansion cohorts, at doses equal to or lower than the MTD, to better characterize the safety, tolerability, PK variability, and preliminary efficacy of single-agent HLX208. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLX208 | Drug | level 1:600mg po Bid level 2:900mg po Bid |
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| 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 | 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 | |
|---|---|---|---|---|
| Jun Guo | Contact | 88196391 | guoj307@126.com | |
| Lu Si | Contact | 88196391 | 88196391 | silu15_silu@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospita | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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Duration of response
| 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 | from the first dose to the time of death due to any causeļ¼assessed up to 2 years |
| Hunan cancer hospital | Recruiting | Changsha | China |
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| West China Hospital of Sichuan University | Not yet recruiting | Chendu | China |
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| Fujian cancer hospital | Not yet recruiting | Fujian | China |
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| Shangxi Bethune Hospita | Not yet recruiting | Taiyuan | China |
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| union Hospital Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | China |
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| Henan cancer hospital | Not yet recruiting | Zhengzhou | China |
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