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

BI 1810631 is an EGFR wild type sparing, selective HER2 inhibitor with potent inhibitory activity on all oncogenic HER2 mutations including the HER2 YVMA insertion allele.

In this study, the sponsor and investigators want to learn:

• How much of the study drug can be given with an acceptable level of side effects
• About the safety, effectiveness and tolerability (side effects) of the study drug
• How much of the study drug is absorbed into the blood and how fast it is removed
• How proteins that indicate the status of your disease are affected with use of the study drug
• If research tests can be used in the future to predict who will benefit from zongertinib (BI 1810631)
• If the study drug prevents or delays tumor growth
• Whether giving the study drug 1 or 2 times per day is more effective and which dose and regimen has less side effects in people with solid tumor type cancer

This is a dose escalation and dose expansion study. In dose escalation, the amount of the study drug given will be increased in each group of research participants, to find the most appropriate dose for further study.  In the dose expansion part of the study, a larger number of participants receive the study drug dose determined to be appropriate in the dose escalation part of the study.

The dose of the study drug you receive will be determined by which dosing level is open at the time you enter the study.

The study regimen will be given in cycles.  Each cycle is 3 weeks.  You will receive the study drug once a day or twice a day, by mouth with water. The study drug will be taken as tablets whole (do not chew or crush the study drug). Your study doctor will tell you which dosing schedule you will follow.