Phase I open-label trial evaluating BI 1810631 as monotherapy in the treatment of patients with advanced or metastatic solid tumors with HER2 aberrations (BEAMION-Lung 1)

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Phase I open-label trial evaluating BI 1810631 as monotherapy in the treatment of patients with advanced or metastatic solid tumors with HER2 aberrations (BEAMION-Lung 1)

Brief description of study

This is a Phase I, open-label, multicentre trial of BI 1810631 administered orally as a single agent. The trial has two parts; Phase Ia, which is the dose escalation part (non-randomised), and Phase Ib which is the dose expansion part. The dose expansion part will consist of 3 cohorts. If needed, the expansion part will include a randomised dose optimization in Cohort 1

Clinical Study Identifier: s22-01411

ClinicalTrials.gov Identifier: NCT04886804

Principal Investigator: Joshua K Sabari.

Other Investigators: Samantha VanMaanen, Jessica Wang, Elaine Shum, Salman Rafi Punekar, Sally Lau, David Mendoza, Natalia Cherkassky, Vamsidhar Velcheti, Melissa L Martinez, Kirby Rodriguez.

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Perlmutter Cancer Center

Clinical Trials & Research Studies