A study of NUC-3373 in combination with other agents in patients with advanced solid tumours

  • Research type

    Research Study

  • Full title

    A Phase Ib/II open label, multi-arm, parallel cohort dose finding and expansion study to assess the safety, pharmacokinetics and efficacy of NUC-3373, a nucleotide analogue, given in combination with standard approved agents in patients with advanced solid tumours

  • IRAS ID

    1005243

  • Contact name

    Stuart Grant

  • Contact email

    MHRA-CESP@nucana.com

  • Sponsor organisation

    NuCana plc

  • Eudract number

    2022-000722-14

  • Clinicaltrials.gov Identifier

    NCT05714553

  • Research summary

    The purpose of this study is to learn more about the effects (safety, effectiveness and tolerability) of a new drug called NUC-3373 in
    combination with other medicines that are approved for the treatment of patients with advanced solid tumours. The study will
    determine the best dose and schedule of NUC-3373 to be used in combination with these other treatments.

    There are different parts to this study, known as modules. In all modules, NUC-3373 will be given with an agent called leucovorin
    (LV). LV is folinic acid (made from B vitamins) and is given in combination with certain cancer drugs to improve anti-cancer
    activity.

    In Module 1, NUC-3373 + LV will be given to participants with an advanced solid tumour that has returned after previous
    treatment with anti-cancer therapies, in combination with pembrolizumab, an immunotherapy drug.

    In Module 2, NUC-3373 + LV will be given in combination with docetaxel to participants with advanced or metastatic non-small
    cell lung cancer (NSCLC) that has returned after previous treatment with other anti-cancer therapies, or who have been unable to
    tolerate previous anti-cancer therapies.

  • REC name

    West Midlands - Coventry & Warwickshire Research Ethics Committee

  • REC reference

    22/WM/0238

  • Date of REC Opinion

    7 Dec 2022

  • REC opinion

    Further Information Favourable Opinion