An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for advanced melanoma with BRAF V600 mutation
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
level 1:600mg po Bid level 2:900mg po Bid
Peking University Cancer Hospita
Beijing, Beijing Municipality, China
RECRUITINGHunan cancer hospital
Changsha, China
RECRUITINGWest China Hospital of Sichuan University
Chendu, China
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: 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: 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 cause,assessed up to 2 years
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Fujian cancer hospital
Fujian, China
NOT_YET_RECRUITINGShangxi Bethune Hospita
Taiyuan, China
NOT_YET_RECRUITINGunion Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
NOT_YET_RECRUITINGHenan cancer hospital
Zhengzhou, China
NOT_YET_RECRUITING