This study will evaluate the pharmacodynamic (PD), safety, antitumor activity, and PK of eFT508 in female subjects who have pathologically documented, radiographically measurable, metastatic or locally advanced and unresectable TNBC and have received prior cancer therapy regimen for metastatic disease, and in male and female subjects who have histologically or cytologically confirmed advanced HCC not amenable to surgical resection and have failed systemic therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
200 mg eFT508 dosed BID for 3 week cycles
City of Hope
Duarte, California, United States
Kansas City Research Institute
Kansas City, Missouri, United States
Level of biomarkers of antitumor activation
Biomarkers of antitumor immune activation in pre- and on treatment tumor biopsies and peripheral blood cells
Time frame: 28 days
Molecular profiling of circulating lymphocytes and tumor-infiltrating lymphocytes (TILs)
Includes determination of T cell clonality via T cell receptor sequencing
Time frame: up to 3 years
Levels of eIF4E and phospho-eIF4E
Assessment of eIF4E and phospho-eIF4E in tumor biopsies by immunohistochemistry, and in circulating peripheral blood cells by phospho-flow cytometry
Time frame: up to 3 years
Number of mutations
Assessment of mutations will be determined for a subset of known cancer driver genes by sequencing tumor DNA
Time frame: up to 3 years
Objective tumor response
determined by irRECIST 1.1, defined as the proportion of subjects who achieve a complete response (CR) or partial response (PR)
Time frame: up to 3 years
Progression Free Survival
as determined by irRECIST 1.1, defined as the interval from the start of study drug to the earlier of the first documentation of disease progression or death from any cause
Time frame: up to 3 years
Proportion of subjects with TEAEs and SAEs
Time frame: up to 3 years
PK plasma concentrations
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taken at the anticipated maximum and minimum plasma concentrations for eFT508
Time frame: up to 21 weeks