4SC AG announced that the first patient has been dosed in its Phase 1/2 study of resminostat as a second-line treatment for patients with advanced and metastatic colorectal KRAS-mutant cancer. This trial (known as the SHORE trial) is a randomized, open-label, multi-center, two-arm study in 70 patients that will evaluate the efficacy, safety and pharmacokinetics of resminostat, in combination with FOLFIRI, a chemotherapy regimen for the treatment of colorectal cancer, versus FOLFIRI alone in the control arm. The primary endpoint of the study is to determine the progression free survival (PFS). The secondary endpoints include progression free survival rate (PFSR) after 8 weeks and every 8 weeks thereafter, the analysis of time-to-progression (TTP), overall survival (OS), analysis of drug safety, tolerability, pharmacokinetics and the investigation of biomarkers.
Resminostat (4SC-201) is an oral pan-histone-deacetylase (HDAC) inhibitor. HDAC inhibitors modify the DNA structure of tumor cells to cause their differentiation and programmed cell death (apoptosis) and are therefore considered to offer a mechanism of action that has the particular potential to halt tumor progression and induce tumor regression.
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