1479-0001

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.

  • Code NKI: M21BIM
  • Code firma: 1479-0001
  • Code clinicaltrials.gov: NCT04886804

Principal Investigator

Dr. F.L. Opdam

Drugs

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

  • Dose escalation: all tumor types – closed
  • Dose expansion: NSCLC – closed

Summary

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.

Read more on clinicaltrials.gov

Patient population

Tumor type: NSCLC, non small cell lung cancer, lung cancer
Tumor characteristics: Her2 amplification, Her2 mutation, Her2 fusion, NRG1 fusion / Her2 Exon20 insertion-mutation (NSCLC)

Additional comments

The study is currently closed and it will open again.