A Study to Test Different Doses of BI 1810631 in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)

Complete Title: 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
Trial Phase: I
Investigator: Christina Baik

The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene. The purpose of the first study part is to find the highest dose of a medicine called BI 1810631 the participants can tolerate. Once this dose is found, it will be used in the second study part to tests whether BI 1810631 can make tumours shrink. In this study, BI 1810631 is given to people for the first time. Participants take BI 1810631 as tablets once a day or twice a day. The participants are in the study for as long as they benefit from and can tolerate treatment. Study doctors regularly check the participants` health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by BI 1810631.

Keywords:
  • Lung Carcinoma, Non-Small-Cell (NSCLC)
  • Neoplasm Metastasis
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Adult
I
Christina Baik
RG1123568
NCT04886804
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
Lung Carcinoma, Non-Small-Cell (NSCLC)
Neoplasm Metastasis