An Open-label Phase I Dose Finding Trial with BI 891065 Alone and in Combination with BI 754091 to Characterise Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Patients with Advanced and/or Metastatic Malignancies

Protocol No
Principal Investigator
Ben George
This study will test the investigational drug, BI 891065 (study drug), for the first time. BI 891065 will be tested by itself in this part of the study (Part A) and in combination with another investigational study drug, BI 754091 in Parts B and C. BI 754091 is presently being tested in another study in patients with advanced cancers. The investigational drugs, BI 891065 and BI 754091, are not approved as treatments for any disease by the United States Food and Drug Administration (FDA) and, thus, their use in this research study is considered investigational. BI 891065 is a member of a new class of cancer drugs called SMAC mimetics. SMAC mimetics are being developed for the treatment of solid tumors and cancers of the blood. They specifically cause cancer cell death (apoptosis, or programmed cell death) and block the ability of cancer cells to survive. This is one mechanism the body uses to get rid of damaged, unwanted or abnormal cells. The process of apoptosis may be blocked in cancer cells due to certain activating and inhibitory molecules. The Inhibitor of Apoptosis (IAP) protein inhibits programmed cell death, and may help tumor cells to live longer. By lowering the level of IAP with BI 891065, tumor cells may be eliminated by programmed cell death. In addition, BI 891065 may lead to a release of cell-signaling molecules (called cytokines) within the tumor and also in other parts of the body. The release of cytokines could make tumor cells sensitive to cell death, a positive effect. In later parts of the study, BI 754091 will also be used. BI 754091 is a medicine that may treat cancer by working with your immune system. The immune system is your body s natural defense against disease. The immune system sends cells called T-cells throughout your body to detect and fight infections and diseases, such as cancer. For some types of cancer, the T-cells do not work as they should and are prevented from attacking the tumors. BI 754091 is a monoclonal antibody (mAb) designed to work by blocking a protein called PD-1 (programmed death 1). Blocking PD-1 allows T-cells and other parts of your immune system to attack tumors.
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
Participating Institutions
Froedtert Hospital
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