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)
The "Basket of Baskets" study investigates a drug called Futibatinib for patients with advanced cancers that harbor a specific genetic change in the tumor (FGFR gene). This Phase II study evaluates how effective and safe this targeted therapy is across different types of cancer that share the same molecular trait. The goal of the study is to measure how many tumors shrink or remain stable during treatment. Eligible participants are adults with solid tumors for whom standard treatments are no longer effective and whose FGFR alteration has been confirmed by a molecular test.