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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
900mg bid po
ORR
Objective response rate(assessed by independent radiological review committee (IRRC) based on the e RECIST Version 1.1)
Time frame: from first dose to the last patient was followed up for 6 month
PFS
Progression-free survival(PFS):assessed by IRRC and the investigator based on the RECIST Version 1.1
Time frame: [Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 1 years]
DOR
Duration of response
Time frame: [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: [Time Frame: from the first dose to the time of death due to any cause,assessed up to 2 years]
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