This is a two part, Phase 1 open label dose escalation and expansion study to assess safety, pharmacokinetics and clinical activity of NUC-3373, a nucleotide analogue, in participants with advanced solid tumours.
The study is split into two phases, the dose escalation Phase and the Dose Expansion Phase.
The dose escalation has 2 parts: Part 1 is to assess the safety and tolerability of NUC-3373 administered weekly as an I.V. infusion on day 1, 8, 15, 22 of a 28-day cycle. Part 2 is assess the safety and tolerability of NUC-3373 administered fortnightly as an I.V. infusion on day 1, 15, of a 28-day cycle
The dose Expansion phase is to obtain a preliminary estimate of anti-tumor activity in specific tumour types as measured by response rate and duration of response and to further assess the safety profile of NUC-3373 administered over multiple cycles at the RP2D.
Males or females with a histologically confirmed diagnosis of any solid tumour not amenable to standard therapy, refractory to standard therapy or for which no standard therapy exists will be eligible to enter the study provided they fulfil eligibility criteria.
To establish the recommended phase 2 dose of NUC 3373.
January 2016 - Opened to recruitment
July 2017 – Expected study end date