Phase I/II study of trifluridine/tipiracil plus XB2001 versus trifluridine/tipiracil in metastatic colorectal cancer.

Fiche publication

Date publication

novembre 2024

Journal

Future oncology (London, England)

Auteurs

Membres identifiés du Cancéropôle Est :
Dr BERTAUT Aurélie , Pr BORG Christophe , Pr GHIRINGHELLI François , Pr LEPAGE Côme , Dr HERVIEU Alice , Dr LIMAGNE Emeric , Dr FUMET Jean-David , Dr ZANETTA Sylvie , Dr THIBAUDIN Marion

Tous les auteurs :
Fumet JD, Roussot N, Bertaut A, Limagne E, Thibaudin M, Hervieu A, Zanetta S, Borg C, Senellart H, Pernot S, Thuillier F, Carnot A, Mineur L, Chibaudel B, Touchefeu Y, Martin-Babau J, Jary M, Labourey JL, Rederstorff E, Lepage C, Ghiringhelli F

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/39530624

Résumé

Trifluridine/tipiracil-bevacizumab is a standard of care in metastatic colorectal cancer (mCRC) after chemotherapy failure. We aim to assess the addition of XB2001 (anti-IL-1 alpha monoclonal antibody) plus trifluridine/tipiracil-bevacizumab in mCRC refractory to standard chemotherapy. This multicenter, randomized, double blind, non-comparative Phase I-II study (ClinicalTrials.gov NCT05201352) will assess the efficacy and safety of trifluridine/tipiracil-bevacizumab and XB2001 in patients with mCRC previously treated for metastatic disease by chemotherapy treatment including oxaliplatin, irinotecan, 5-FU, antiangiogenic and/or anti-EGFR if indicated. Primary end point of Phase I is the safety according to the Maximum Tolerated Dose (MTD) of XB2001. Primary end point of Phase II is the efficacy of trifluridine/tipiracil-bevacizumab + XB2001 in term of 6-month overall survival. Ancillary analysis will be performed.