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

Autor: Fumet JD; Department of Medical Oncology, Center GF Leclerc, Dijon, France.; Research Platform in Biological Oncology, Dijon, France.; University of Burgundy-Franche Comté, Dijon, France., Roussot N; Department of Medical Oncology, Center GF Leclerc, Dijon, France.; Research Platform in Biological Oncology, Dijon, France.; University of Burgundy-Franche Comté, Dijon, France.; UMR INSERM 1231, Dijon, France., Bertaut A; Department of Epidemiology & Biostatistics, Georges François Leclerc Center, Dijon, France., Limagne E; Research Platform in Biological Oncology, Dijon, France.; University of Burgundy-Franche Comté, Dijon, France.; UMR INSERM 1231, Dijon, France., Thibaudin M; Research Platform in Biological Oncology, Dijon, France.; University of Burgundy-Franche Comté, Dijon, France.; UMR INSERM 1231, Dijon, France., Hervieu A; Department of Medical Oncology, Center GF Leclerc, Dijon, France.; Department of Medical Dermatology-Oncology, Institut Gustave Roussy, Villejuif, France., Zanetta S; Department of Medical Oncology, Center GF Leclerc, Dijon, France., Borg C; Department of Medical Oncology, University Hospital of Besancon, Besancon, France., Senellart H; Department of Medical Oncology, Institut de Cancérologie de l'Ouest, Saint Herblain, France., Pernot S; Department of Medical Oncology, Institut Bergonié, Bordeaux, France., Thuillier F; Department of Medical Oncology, University Hospital of Limoges, Limoges, France., Carnot A; Department of Medical Oncology, Centre Oscar Lambret, Lille, France., Mineur L; Department of Medical Oncology, Institut Sainte Catherine, Avignon, France., Chibaudel B; Department of Medical Oncology, Franco-British Institute, Levallois-Perret, France., Touchefeu Y; Nantes Université, CHU Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), Hépato-Gastroentérologie, Inserm CIC 1413, Nantes, F-44000, France., Martin-Babau J; Department of Medical Oncology, Hopital privé des Cotes D'Armor, Plérin, France., Jary M; Department of Medical Oncology, University Hospital of Clermont Ferrand, Clermont Ferrand, France., Labourey JL; Department of Medical Oncology, Carcassonne Hospital, Carcassonne, France., Rederstorff E; Department of Epidemiology & Biostatistics, Georges François Leclerc Center, Dijon, France., Lepage C; Francois Mitterrand Hospital, Dijon, France., Ghiringhelli F; Department of Medical Oncology, Center GF Leclerc, Dijon, France.; Research Platform in Biological Oncology, Dijon, France.; GIMI Genetic & Immunology Medical Institute, Dijon, France.; University of Burgundy-Franche Comté, Dijon, France.; UMR INSERM 1231, Dijon, France.
Jazyk: angličtina
Zdroj: Future oncology (London, England) [Future Oncol] 2024; Vol. 20 (38), pp. 3077-3085. Date of Electronic Publication: 2024 Nov 12.
DOI: 10.1080/14796694.2024.2415280
Abstrakt: Aim: 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. Methods: 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.
Databáze: MEDLINE