This clinical trial is focused on studying certain types of cancer, specifically HER2-positive metastatic breast cancer and metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. These are advanced forms of cancer that have spread to other parts of the body. The study is testing a new treatment approach using a combination of medications. One of the medications being tested is called zongertinib (also known by its code name BI 1810631), which is taken orally as a film-coated tablet. The other medications involved are trastuzumab deruxtecan and trastuzumab emtansine, both of which are given through an intravenous infusion, meaning they are administered directly into the bloodstream.
The purpose of this study is to find a suitable dose of zongertinib when used in combination with either trastuzumab deruxtecan or trastuzumab emtansine, and to see if these combinations can help people with these types of cancer. The study is divided into two main parts. The first part, called Phase Ib, involves gradually increasing the dose of zongertinib to determine the highest dose that can be given safely. The second part, Phase II, aims to find out how effective the treatment is at shrinking tumors or stopping them from growing. Participants will receive the study medications and be monitored for any side effects and how well the treatment is working.
Throughout the study, participants will have regular check-ups and tests to assess their health and the progress of their cancer. The study will help researchers understand the best way to use these medications together and whether they can provide a new treatment option for people with these advanced cancers. The study is expected to continue until 2028, with recruitment starting in 2024.
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Italy 
Spain 