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oai:recercat.cat:11351/64232025-10-24T10:33:37Zcom_2072_378070com_2072_378040col_2072_378092

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 Bono, Petri Massard, Christophe Peltola, Katriina J Azaro Pedrazzoli, Analía Beatriz Kristeleit, Rebecca S Rodon Ahnert, Jordi Italiano, Antoine Institut Català de la Salut [Bono P, Peltola KJ] Comprehensive Cancer Centre, Helsinki University Central Hospital, Helsinki, Finland. Faculty of Medicine, University of Helsinki, Helsinki, Finland. [Massard C] Cancer Centre, Drug Development Department, DITEP, Gustave Roussy, Villejuif, France. [Azaro A, Rodon JA] Servei d’Oncologia Mèdica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Italiano A] Early Phase Trials Unit, Institut Bergonié, Bordeaux, France. Faculty of Medicine, University of Bordeaux, Talence, France. [Kristeleit RS] Research Department of Oncology, University College London Cancer Institute, London, UK Vall d'Hebron Barcelona Hospital Campus Càncer - Tractament Metàstasi DISEASES::Neoplasms::Neoplastic Processes::Neoplasm Metastasis DISEASES::Neoplasms Other subheadings::Other subheadings::Other subheadings::/drug therapy ENFERMEDADES::neoplasias::procesos neoplásicos::metástasis neoplásica ENFERMEDADES::neoplasias Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia Estudi d'escalada de dosis; Fase I; Tumors sòlids Estudio de escalada de dosis; Fase I; Tumores sólidos Dose escalation study; Phase I; Solid tumours 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. The study was sponsored by Orion Corporation, Orion Pharma, Espoo, Finland. 2021-10-20T08:11:25Z 2021-10-20T08:11:25Z 2020-12 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Bono P, Massard C, Peltola KJ, Azaro A, Italiano A, Kristeleit RS, et al. 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. ESMO Open. 2020 Dec;5(6):e001081. 2059-7029 https://hdl.handle.net/11351/6423 10.1136/esmoopen-2020-001081 33262202 000597167800002 http://hdl.handle.net/11351/6423 eng ESMO Open;5(6) https://doi.org/10.1136/esmoopen-2020-001081 Attribution-NonCommercial 4.0 International http://creativecommons.org/licenses/by-nc/4.0/ info:eu-repo/semantics/openAccess application/pdf application/pdf BMJ Scientia