This is the first study where BAY1238097 is given to humans. Impact of the study is to
evaluate if patients with advanced cancer show clinical benefit under the treatment with
BET(Bromodomain and extraterminal domain family ) inhibitor.Patients with solid tumors (all
comers) and lymphoma will receive the study drug treatment in an escalation scheme (no
placebo group) to determine the safety, tolerability and maximum tolerated dose (MTD) of
BAY1238097. the relative bioavailability of Liquid Service Formulation and tablets will be
determined
After MTD is defined, patients with solid tumors (all comer, hepato cellular carcinoma, lung
cancer, NUT(nuclear protein in testis)-midline carcinoma), melanoma and lymphoma will be
enrolled A separate escalation scheme will be applied to patients with leucemias, and at the
maximal tolerated dose, patients with AML amd multiple myeloma will be enrolled.
the study will also assess the pharmacokinetics, biomarker status, pharmacodynamic parameters
of BAY1238097 and tumor response to the treatment.
BAY1238097 will be given twice weekly as oral application. Treatment will be stopped if the
tumor continues to grow, if side effects occur, wich the patient cannot tolerate or if the
patient decides to withdraw from the treatment.