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Article History

Received: 9 November 2023

Accepted: 11 March 2024

First Online: 2 April 2024

Declarations

:

: The study was reviewed and given a favourable opinion by the South-Central Oxford C Research Ethics Committee [Ref 15/SC/0644] and authorised by the Medicines and Healthcare products Regulatory Agency. It was conducted under the oversight of the Independent Early Phase Trial Oversight Committee (IEPTOC) acting as the Trial Steering Committee and as part of the portfolio of trials in the registered UKCRC Oxford Clinical Trials Research Unit (OCTRU) at the University of Oxford. It has followed their Standard Operating Procedures ensuring compliance with the principles of Good Clinical Practice and the Declaration of Helsinki and any applicable regulatory requirements. All participants signed a consent form before commencing study participation.

: Not applicable.

: SPB discloses institutional funding as PI or CI to support clinical trials from: NuCana plc, Redx Pharma plc, UCB (Union Chimique Belge), Nurix Therapeutics, BioNTech, Moderna, Regeneron, Theolytics and Medannex. Consulting agreements with Ellipses, Theolytics, Oxford Drug Design, Pathios, UCB and Immunocore. Director and founder of RNA Guardian Ltd., patent application WO2016075455A1. TRJE discloses Honoraria (payable to employing institution): Ascelia, AstraZeneca, Bicycle Therapeutics, BMS, Eisai, Medivir, MSD, Nucana, Roche/Genentech, Seagen; Speakers’ Bureau (payable to employing institution): AstraZeneca, BMS, Eisai, Ewopharma, Medivir, MSD, Nucana, Roche/Genentech, United Medical; Research Funding (payable to employing institution): Adaptimmune, Astellas Pharma, AstraZeneca, Athenex, Avacta, Basilea, Beigene, Berg Pharma, Bicycle Therapeutics, BiolineRx, Boehringer Ingelheim, BMS, Celgene, Clovis Oncology, Codiak, CytomX Therapeutics, Eisai, GlaxoSmithKline, Halozyme, Immunocore, iOnctura, Iovance Biotherapeutics, Janssen, Johnson & Johnson, Lilly, Medivir, Merck Serono, MSD, MiNA Therapeutics, Modulate Pharma, Novartis, Nucana, Plexxikon, Roche/Genentech, Sanofi/Aventis, Sapience Therapeutics, Seattle Genetics, Sierra Pharma, Starpharma, Seagen, UCB, Verastem, Vertex; Expert Testimony (payable to employing institution): Medivir; Support to attend national / international conferences (personal): BMS, Eisai, MSD, Nucana, Pierre Fabre. VMC discloses institutional support from NuCana plc, personal honoraria from Servier, membership of MSD UK Advisory board and NIHR committee. FA discloses current employment by Astra Zeneca but not at the time of this study. PS, FK, SL, TH, DT, LG, CQ, MP, VMC and GJV report no competing interests to disclose. DJH discloses funding of translational research and personal salary and stock interests from NuCana plc.