Phase I/IIa, open-label, multicentre study to evaluate the optimal dosing and safety of ODM-203 in patients with advanced or metastatic solid tumours

Petri Bono, Christophe Massard, Katriina J. Peltola, Analía Azaro, Antoine Italiano, Rebecca S. Kristeleit, Giuseppe Curigliano, Ulrik Lassen, Hendrik Tobias Arkenau, Pasi Hakulinen, Chris Garratt, Tarja Ikonen, Mika V.J. Mustonen, Jordi A. Rodon

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Genetic alterations in fibroblast growth factor receptor (FGFR) and vascular endothelial growth factor receptor (VEGFR) signalling are observed in various tumours. We report a first-in-human phase I/IIa trial evaluating tolerability, pharmacokinetics and preliminary antitumour activity of ODM-203, a novel FGFR and VEGFR inhibitor. Methods: Open-label, non-randomised, multicentre, phase I/IIa dose escalation and expansion study in patients with advanced or metastatic solid tumours. Results: Overall, 84 patients received treatment; optimal tablet dose was found to be 400 mg/day with food. All patients experienced at least one adverse event; the majority (89.2%) were grade 1 or 2% and 70.4% were considered treatment related. The most commonly reported events were bilirubin increase-related events (75%) and diarrhoea (50%). Overall response rate was 9.2% and median progression-free survival was 16.1 and 12.4 weeks for patients with aberrant or non-aberrant FGFR tumours. Median time on treatment was 10.1 weeks for all patients and 14.5 weeks for patients who received 400 mg tablets. Conclusion: This study suggests ODM-203 400 mg/day results in sufficient plasma concentrations and acceptable tolerability in most patients. Preliminary signs of therapeutic activity of ODM-203 in patients with solid tumours was observed.

Original languageEnglish
Article numbere001081
JournalESMO Open
Volume5
Issue number6
DOIs
Publication statusPublished - Dec 1 2020

Keywords

  • dose escalation study
  • FGFR and VEGFR inhibitor
  • ODM-203
  • phase I
  • solid tumours

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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