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.

• 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 the use of the study drug
• If research tests can be used in the future to predict who will benefit from 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 have fewer side effects in people with solid tumor type cancer