On November 1, 2018 NuCana plc (NASDAQ: NCNA) announced the first patients have been enrolled in the NuTide:302 Study (Press release, Nucana BioPharmaceuticals, NOV 1, 2018, View Source [SID1234530523]). This study is evaluating NUC-3373 in combination with other agents typically administered with 5-fluorouracil (5-FU) in patients with advanced colorectal cancer. NUC-3373 is NuCana’s ProTide transformation of the active anti-cancer metabolite of 5-FU.
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The NuTide:302 study was preceded by the first-in-human Phase I study (NuTide:301) of single-agent NUC-3373 in patients with advanced solid tumors. Initial results from NuTide:301 were presented in October 2018 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in which NUC-3373 was observed to have had durable single-agent anti-cancer activity in patients who had exhausted all current standards of care. Furthermore, NuCana believes NUC-3373 demonstrated potential safety and dosing administration advantages as compared with 5-FU. In that study, three patients achieved durable Stable Disease with responses lasting more than nine months at the time of data cutoff. Both dosing regimens were observed to be well tolerated with no unexpected adverse events (AEs). Of particular note, no patients developed hand-foot syndrome, a common and debilitating side effect of fluoropyrimidine treatment.
Hugh Griffith, NuCana’s Chief Executive Officer, stated: "NUC-3373 is our second product candidate developed from our proprietary ProTide technology. The goal, as with all our ProTides, is to significantly improve the efficacy and safety of commonly used anti-cancer agents. We believe NUC-3373 has the potential to replace 5-FU as the standard of care in the treatment of a wide range of cancers and we are pleased to have enrolled the first patients in this combination study."
NuTide:302 is a two-part study of NUC-3373 administered every two weeks as an intravenous (IV) infusion. In part 1, NUC-3373 will be combined with leucovorin, with a plan to enroll 12 patients. In part 2, NUC-3373, with or without leucovorin, will be studied in separate combinations with oxaliplatin, oxaliplatin plus bevacizumab, oxaliplatin plus panitumumab and irinotecan, and irinotecan plus cetuximab, with six patients planned per cohort. The primary objective of the study is to identify a recommended dose of NUC-3373 in combination with standard agents used in treating advanced colorectal cancer. The study will also make a preliminary assessment of the anti-tumor activity of the combinations.
More information about this study may be found at: View Source