BOB Modul2

cross-entity / Basket
General
other systemic therapies
Part A includes a molecular profiling program for subjects with advanced solid tumors (iPROFILER) and a molecular tumor board to select the most appropriate treatment based on the molecular alterations found in the iPROFILER. Part B includes iBASKET, a modular investigator-initiated basket study for subjects with selected molecular alterations.The current protocol contains the Module 2 of iBASKET with the following arms: o Arm 2A: Known pathogenic FGFR1-3 mutations. o Arm 2B: Variants of unknown significance in FGFR1-3 with functional relevance or pathogenic FGFR4 mutations.o Arm 2C: Highly amplified FGFR1-3 (NGS based CN >= 6) WITH high FGFR1-3 mRNA (above the percentile 95 for general cancer population by using Nanostring Gene expression profile in solid tumours (with the exception of gastric and breast cancer) Arm 2D: Highly amplified FGFR1-3 (NGS based CN >= 6) WITHOUT high FGFR1-3 mRNA (above the percentile 95 for general cancer population by using Nanostring Gene expression profile in solid tumours (with the exception of gastric and breast cancer)
Part A includes a molecular profiling program for subjects with advanced solid tumors (iPROFILER) and a molecular tumor board to select the most appropriate treatment based on the molecular alterations found in the iPROFILER. Part B includes iBASKET, a modular investigator-initiated basket study for subjects with selected molecular alterations.The current protocol contains the Module 2 of iBASKET with the following arms: o Arm 2A: Known pathogenic FGFR1-3 mutations. o Arm 2B: Variants of unknown significance in FGFR1-3 with functional relevance or pathogenic FGFR4 mutations.o Arm 2C: Highly amplified FGFR1-3 (NGS based CN >= 6) WITH high FGFR1-3 mRNA (above the percentile 95 for general cancer population by using Nanostring Gene expression profile in solid tumours (with the exception of gastric and breast cancer) Arm 2D: Highly amplified FGFR1-3 (NGS based CN >= 6) WITHOUT high FGFR1-3 mRNA (above the percentile 95 for general cancer population by using Nanostring Gene expression profile in solid tumours (with the exception of gastric and breast cancer)