Corden Pharma GmbH

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.

To evaluate the efficacy and safety of tucatinib combined with trastuzumab and mFOLFOX6 versus mFOLFOX6 with or without bevacizumab or cetuximab as first-line treatment (1L) in adult patients with HER2-positive (HER2+) metastatic colorectal cancer (mCRC)

Comparison of progression-free survival (PFS) between the two treatment groups as assessed by the investigators based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST v1.1) Comparison of overall survival (OS) between the two treatment groups