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

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Petri Bono1, Christophe Massard2, Katriina J Peltola1

  • 1Comprehensive Cancer Centre, Helsinki University Central Hospital, Helsinki, Finland; Faculty of Medicine, University of Helsinki, Helsinki, Finland.

ESMO Open
|December 2, 2020
PubMed
Abstract

Insights

This phase I/IIa trial assessed ODM-203, a novel fibroblast growth factor receptor (FGFR) and vascular endothelial growth factor receptor (VEGFR) inhibitor, in patients with solid tumours. ODM-203 demonstrated acceptable tolerability and preliminary anti-tumour activity at 400 mg/day.

Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Aberrant signaling in fibroblast growth factor receptor (FGFR) and vascular endothelial growth factor receptor (VEGFR) pathways is implicated in various cancers.
  • ODM-203 is a novel inhibitor targeting both FGFR and VEGFR signaling pathways.

Purpose of the Study:

  • To evaluate the tolerability and pharmacokinetics of ODM-203 in a first-in-human phase I/IIa trial.
  • To assess the preliminary anti-tumour activity of ODM-203 in patients with advanced or metastatic solid tumours.

Main Methods:

  • An open-label, non-randomised, multicentre phase I/IIa dose escalation and expansion study was conducted.
  • Eighty-four patients with advanced or metastatic solid tumours received ODM-203 treatment.
  • The optimal dose was determined to be 400 mg/day taken with food.

Main Results:

  • The optimal dose of ODM-203 was 400 mg/day with food.
  • Most adverse events were grade 1 or 2, with the most common being bilirubin increase (75%) and diarrhea (50%).
  • An overall response rate of 9.2% was observed, with median progression-free survival of 16.1 weeks for patients with aberrant FGFR tumours.

Conclusions:

  • ODM-203 at 400 mg/day achieved sufficient plasma concentrations and was generally well-tolerated.
  • Preliminary therapeutic activity of ODM-203 was observed in patients with solid tumours, warranting further investigation.
Keywords:
FGFR and VEGFR inhibitorODM-203dose escalation studyphase Isolid tumours

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