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Rigshospitalet - a part of Copenhagen University Hospital
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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

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  • 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
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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.

TRIAL REGISTRATION NUMBER: NCT02264418.

Original languageEnglish
JournalESMO Open
Volume5
Issue number6
Pages (from-to)e001081
ISSN2059-7029
DOIs
Publication statusPublished - Dec 2020

ID: 61506747