An Open-Label Multicenter Non-Randomized Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety Tolerability and Anti-Tumor Activity of ATP128 With or Without BI 754091 in Patients With Stage IV Colorectal Cancer

Brief description of study

The purpose of the study is to determine the safety and tolerability of ATP128 alone or in combination with BI 754091. ATP128 is a self-adjuvanted chimeric recombinant protein vaccine being developed in combination with programmed cell death 1 (PD-1) blockade for the treatment of microsatellite stable (MSS) patients not responding to PD-1 blockade. The PD-1 inhibitor being tested with ATP128 is the BI 754091 compound which belongs to the human immunoglobulin G4 (IgG4) subclass of antibodies. The study drugs ATP128 and BI 754091 are investigational, which means that they have not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test these agents in the current trial.

Clinical Study Identifier: s20-01585 Identifier: NCT04046445

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