Corden Pharma GmbH

The primary objective is to demonstrate a non-flat dose-effect curve based on the annual rate of decline in FVC during treatment for up to 52 weeks using three different oral doses of BI 1819479 and to evaluate the quantitative treatment effect size and dose-effect relationship. The secondary objective is to evaluate efficacy by comparing the differences in FVC decline (absolute change in FVC from baseline at Week 24) between the three different doses of BI 1819479 and placebo. Evaluation of secondary and other efficacy and safety parameters will further support dose (range) selection for subsequent development.

The overall objectives of this trial are to evaluate dose-ranging data of BI 1569912 compared with placebo as add-on treatment in patients with MDD who have an inadequate response to ongoing antidepressant therapy, provide clinical proof of concept (PoCC), and support dose selection for the pivotal study.

Researchers are looking for better ways to treat people with advanced solid tumors. Advanced solid tumors are types of cancer that may have spread to nearby tissues, lymph nodes, and/or distant parts of the body, and are unlikely to be cured or controlled by currently available treatments. This research is focusing on certain types of skin cancer, kidney cancer, stomach cancer, and lung cancer. The investigational treatment BAY2965501 is currently in development as a monotherapy or in combination with a drug called pembrolizumab for the treatment of people with advanced solid tumors. BAY2965501 blocks an enzyme in T cells, which activates them. T cells are a type of immune cell known to have anti-cancer effects, and BAY2965501 is a potential new type of immunotherapy. The main objectives of this first-in-human trial are to understand - How safe different doses of BAY2965501 are when used alone or in combination; - How well tolerated (also called tolerability) the medical problems caused by BAY2965501 when used alone or in combination; - What is the maximum dose of a single drug or combination; - How a single drug or combination enters, passes through, and is eliminated from the body. Chinese patients are not currently participating in the combination group.