Patients will be enrolled in two stages: * Dose-escalation stage: Approximately 15-30 patients will be enrolled. * Dose-expansion stage: 6-12 patients will be enrolled. Dose-escalation slots will be filled first, then dose-expansion slots.
* Dose-escalation stage : designed as classical 3+3 to determine MTD or RP2D to evaluate approximately GX-I7. * Dose-expansion stage : designed to enroll additional 6-12 patients to acquire additional safety and pharmacodynamic data to more fully inform the dose selection for RP2D
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
35
GX-I7 25mg/ml/vial
Severance Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Seoul St. Mary's Hospital, of the Catholic University
Seoul, South Korea
DLT
Incidence of nature of DLTs
Time frame: up to 24 months
AE
Incidence, nature and severity of adverse events graded according to NCI CTCAEv4.0
Time frame: up to 24 months
ECG test evaluated by QTc
Change QTc from baseline (\> 500 msec)
Time frame: up to 24 months
Pharmacokinetic (PK) profile
Serum concentration of GX-I7 at specified timepoints for the Area under the concentration time-curve (AUC)
Time frame: up to cycle 3 day 1(approximately 9 weeks)
Anti-tumor activity
Objective response, defined as a complete response (CR) or partial response (PR) per RECIST v.1.1, as determined by the investigator
Time frame: up to 24 months
Immunogenicity
Incidence of anti-drug antibodies (ADAs) during the study
Time frame: up to 24 months
Exploratory Biomarker
Changes in immune infiltrates, immune-related gene expression in tumor tissue prior to and during study treatment
Time frame: up to 24 months
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