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news.4SC has dosed first patient in a randomized, open-label, multi-centre, two-arm Phase I/II Shore study with the oral pan-histone deacetylase (HDAC) inhibitor Resminostat as a second-line treatment for patients with advanced and metastatic colorectal KRAS-mutant cancer.
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In the study, the company will investigate the safety and efficacy and pharmacokinetics of Resminostat in conjunction with Folfiri versus Folfiri alone in the control arm.
In the combination arm of the study patients are expected to be treated with the maximum tolerated dose of Resminostat in combination with Folfiri, which will be determined through an initial dose-escalation phase, evaluating 200mg, 400mg, 600mg and 800mg of Reminostat together with Folfiri in approximately 20 patients.
In both study arms, treatment may continue until there is evidence of progressive disease or the patient leaves the trial for other reasons.
4SC chief development officer Bernd Hentsch said by evaluating the efficacy of Resminostat in patients carrying KRAS-mutant tumours, they hope to open a second-line treatment option for this colorectal cancer patient population where there is an increased unmet medical need since they cannot be treated with current EGFR targeting agents.