To evaluate the safety and tolerability of escalating doses GX-I7 in combination with standard dose pembrolizumab, and to evaluate objective response rate (ORR) in subjects with refractory or relapsed TNBC
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Ajou Medical Center
Suwon, Gyeonggi-do, South Korea
National Cancer Center
Goyang-si, South Korea
Incidence and nature of DLTs
To evaluate the safety and tolerability of GX-I7 in combination with standard dose pembrolizumab
Time frame: during the first 5 weeks
Incidence, nature and severity of adverse events
graded according to NCI CTCAE v5.0
Time frame: up to 24month
Objective response rate (ORR)
defined as percentage of subjects with a complete response (CR) or partial response (PR) per RECIST v.1.1
Time frame: up to 24month
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