An open label Phase I dose escalation trial with dose confirmation and expansion of BI 1810631 as monotherapy in patients with advanced or metastatic solid tumors with HER2 aberrations

Brief description of study

In the first part of the study, we will test the safety, tolerance, and how the body processes a drug called BI 1810631 in patients with advanced and spreading tumors that have specific genetic changes. The drug will be given as a pill, either twice a day or once a day. We will also determine the highest dose that patients can tolerate without severe side effects and the recommended dose for further studies.

In the second part of the study, we will assess the effectiveness of BI 1810631 in different groups of patients. In some groups, we will evaluate how well the tumors respond to the treatment based on independent reviews, while in another group, we will rely on assessments by the patient's doctors. We will also continue to examine the safety and how the body processes the drug in patients with HER2 mutation positive advanced/metastatic non-small cell lung cancer (NSCLC).

The main goals of the study are to determine the maximum tolerated dose of BI 1810631 and the number of patients who experience severe side effects. In the second part of the study, we will also measure the response of the tumors to the treatment according to specific evaluation criteria. Additionally, we will look at other factors such as the duration of response, disease control, progression-free survival, and how the drug affects the body in terms of its levels in the blood.

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