Tinostamustine (EDO-S101) is a first-in-class alkylating deacetylase inhibitor designed to improve drug access to deoxyribonucleic acid (DNA) strands, induce DNA damage and counteract its repair in cancer cells. The main purpose of this study is to assess the safety, tolerability and efficacy of Tinostamustine in subjects with advanced solid tumours. Subjects will be given Tinostamustine via intravenous infusion on Days 1 and 15 of a 4-week cycle, the dose and infusion time will vary depending on the phase of the study.
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Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE V4.03 on Phase 1
Timeframe: From each patient's time of first dose administration to discontinuation of study drug (at any time or D28 of the last treatment cycle), up to 6 months.
Clinical Benefit Response Rate in Selected Solid Tumor Cohorts on Phase 2
Timeframe: From start treatment and assessed after every 2 cycles until determination of stable disease and follow up for up to 84 days.
Highest Change From Baseline in QTcF in Sub-studies
Timeframe: From cycle 1 and at every cycle on treatment days D1 and D15, assessed pre-dose and post-start of infusion at 30 and 80mins (Substudy 2 - up to 6 months) and 30, 60, 90, 120 and 180mins (substudy 1 - up to 6 months).