Solid Tumours Clinical Trial
Official title:
A Phase I, Gene Alteration-based, Open Label, Multicenter Study of Oral Debio 1347 (CH5183284) in Patients With Advanced Solid Malignancies, Whose Tumours Have an Alteration of the FGFR 1, 2 or 3 Genes
This study is primarily designed to assess the safety and the tolerability of Debio1347
(CH5183284) in patients with advanced solid malignancies, whose tumours have an alteration of
the Fibroblast Growth Factor Receptor (FGFR) 1, 2 or 3 genes, for whom standard treatment
does not exist or is not indicated.
The main objective of Part A is to identify the dose-limiting toxicities (DLTs) and estimate
the maximum tolerated dose (MTD) based on the safety and tolerability of Debio1347 orally
administered daily to these patients, in order to determine the recommended dose.
The main objective of Part B is to evaluate the safety profile at the recommended dose, in a
larger cohort of these patients.
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