This is a Phase 2, open-label, multi-center, single arm study in subjects with advanced thymic carcinoma after failure of platinum-based combination chemotherapy. Subjects should have documented progressive disease while on platinum-based combination chemotherapy. If subjects discontinued platinum-based therapy due to reasons other than progressive disease, subjects should have completed at least 2 cycles of platinum-based combination chemotherapy before the commencement of documented progressive disease. Subjects will be treated with KN046 5 milligram per kilogram every 2 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
95
KN046 5 milligram per kilogram, every 2 weeks
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
ORR
ORR (best overall response) per RECIST v1.1 calculated as the proportion of subjects with a best overall response defined as confirmed complete response or confirmed partial response (CR+PR) by Independent Review Committee;
Time frame: up to 2 years
DOR
DOR (duration of response), calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to underlying cancer;
Time frame: up to 3 years
DCR
DCR (disease control rate), calculated as the proportion of subjects with best overall response of CR, PR, or SD (stable disease);
Time frame: up to 3 years
CBR
CBR (clinical benefit rate), calculated as the proportion of subjects with best overall response of CR, PR, or SD on at least 24 weeks;
Time frame: up to 3 years
PFS
PFS (progression free survival), defined as time from first dose of trial treatment to progression or death due to any cause;
Time frame: up to 3 years
TTR
TTR (time to response), calculated as the time from first dose of trial treatment to first documented response (CR+PR);
Time frame: up to 3 years
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