The study will be conducted in 2 cohorts. A single-center design for the tumor microenvironment (TME) cohort (Cohort 1), and a multicenter design for the less frequent intravenous (IV) dosing cohort (Cohort 2).
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Changes in density (cell counts per mm2) of immune cell (including total T cells, CD8+ T cells, CD56+ cells and Treg cells)
Timeframe: From the time of the Patient's pre-treatment biopsy to the time of the Patient's on-treatment biopsy
Changes in ratios (including T/Treg, CD8+/Treg, CD56+/Treg) based on immunohistochemistry (IHC) and/or immunofluorescence (IF) in the TME between pretreatment and on-treatment (Cycle 2 Day 8) paired tumor biopsies
Timeframe: From the time of the Patient's pre-treatment biopsy to the time of the Patient's on-treatment biopsy
Incidence of dose-limiting toxicity (DLT)
Timeframe: From the first dose through end of dose-limiting toxicity observation period (up to 24 months)