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

Future Oncol. 2024;20(38):3077-3085. doi: 10.1080/14796694.2024.2415280. Epub 2024 Nov 12.

Abstract

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.

Keywords: IL-1; XB2001; chemotherapy; colorectal cancer; trifluridine/tipiracil.

Plain language summary

[Box: see text].

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols* / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols* / therapeutic use
  • Bevacizumab / administration & dosage
  • Bevacizumab / adverse effects
  • Bevacizumab / therapeutic use
  • Clinical Trials, Phase I as Topic*
  • Clinical Trials, Phase II as Topic*
  • Colorectal Neoplasms* / drug therapy
  • Colorectal Neoplasms* / mortality
  • Colorectal Neoplasms* / pathology
  • Double-Blind Method
  • Drug Combinations*
  • Female
  • Humans
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Multicenter Studies as Topic
  • Neoplasm Metastasis
  • Pyrrolidines* / administration & dosage
  • Pyrrolidines* / therapeutic use
  • Thymine* / administration & dosage
  • Trifluridine* / administration & dosage
  • Trifluridine* / adverse effects
  • Trifluridine* / therapeutic use
  • Uracil / administration & dosage
  • Uracil / analogs & derivatives
  • Uracil / therapeutic use

Substances

  • Bevacizumab
  • Drug Combinations
  • Pyrrolidines
  • Thymine
  • tipiracil
  • Trifluridine
  • trifluridine tipiracil drug combination
  • Uracil

Associated data

  • ClinicalTrials.gov/NCT05201352