At a glance
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Beamion LUNG-1: An Open Label, Phase I Dose Escalation Trial, With Dose Confirmation and Expansion, of Zongertinib (BI 1810631) as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations
In Brief
A Phase 1 clinical trial evaluating zongertinib for Neoplasm Metastasis and Non-Small Cell Lung Cancer. Active but no longer recruiting, targeting 608 participants across 85 sites in 18 countries.
Signals
Detailed 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 zongertinib the participants can tolerate. Once this dose is found, it will be used in the second study part to test whether zongertinib can make tumours shrink. In this study, zongertinib is given to people for the first time. Participants take zongertinib 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 zongertinib.
Study Details
Timeline
Arms & Interventions
Consecutive cohorts of patients treated with escalating doses of BI 1810631 monotherapy.
Cohort only in the United States of America (USA)
Cohort only in Japan
Cohort only in the United States of America (USA)
Cohort only in China
Interventions
zongertinib