Beamion PANTUMOR-1: A Phase II, multicenter, multi-cohort, open-label trial to evaluate the efficacy and safety of oral zongertinib (BI 1810631) for the treatment of selected HER2-mutated or overexpressed/amplified solid tumors

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 / agent can be given with an acceptable level of side effects
• The effects of the study drug / agent (good and bad)
• How much of the study drug / agent is absorbed into the blood and how fast it is removed
• How the study drug / agent is acting on your body

This is a Phase II, open-label, multi-centre, multi-cohort trial to evaluate the preliminary efficacy and safety of zongertinib for the treatment of selected HER2-mutated or overexpressed/amplified tumors.

The trial will include 10 cohorts of different tumor types. There will be 8 tumor-specific cohorts (Cohorts 1 to 5 and Cohorts 7 to 9) and 2 tumor agnostic cohorts (Cohorts 10 and 6).

Zongertinib will be administered daily in 21-day cycles