This is a two-part Phase I, open label, dose-escalation, study of NUC-1031 as a single agent
in patients with advanced solid tumours who have failed to respond to or who have relapsed
after treatment with standard therapy. NUC-1031 is a ProTide of gemcitabine, a drug that has
been used widely and effectively against cancers for many years. Both NUC-1031 and
gemcitabine work by preventing cancer cells from dividing by attacking their DNA
(deoxyribonucleic acid). Non clinical studies have shown that NUC-1031 is more effective than
gemcitabine because it is able to reach cancer cells by passive diffusion, is less easily
degraded by the cancer cell, and delivers the monophosphate form of the active agent. The
first part of the study is to determine recommended phase 2 dose by dose escalation and the
second part is to explore preliminary anti-tumour activity.