Switzerland-based Debiopharm Group has initiated patient treatment in a Phase I clinical trial of Debio 1347, an orally available small molecule targeting advanced solid tumours with FGFR alterations.
The Phase I trial is an open label multicentre study of Debio 1347 (CH5183284), a selective FGFR 1, 2, 3 inhibitor, in patients with advanced solid tumours.
The study is aimed at identifying the dose limiting toxicity (DLT), as well as assessing the maximal tolerated dose (MTD) of Debio 1347 based on the safety and tolerability of the product during a daily oral administration to patients suffering from advanced solid malignancies that have an alteration of the FGFR 1, 2 or 3 genes.
Under the expansion part, the study will also evaluate the safety profile at the recommended dose of Debio 1347 in a larger group of patients.
Debiopharm Group president and founder Rolland-Yves Mauvernay said: "Debio 1347 (CH5183284) is going to be developed with a companion diagnostic and we believe it could become a personalised treatment option for patients suffering from solid tumours which could significantly improve their outcomes."
A licence agreement has been signed between Debiopharm and Chugai Pharmaceutical in December 2012 for the development and commercialisation of Debio 1347 in all countries.
Debio 1347 is currently being tested in a Phase I in several oncology centres of excellence in the US and Europe.
It is expected to become a tailored treatment with high anti-tumour activity.