Clinical Trial

A Phase II, multicentre, multicohort, 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 tumours 

MOA: Zongertinib is an EGFR wild-type sparing, selective HER2 inhibitor with potent inhibitory activity on all oncogenic HER2 mutations.

Key Eligibility Criteria:

• Subjects with a previously treated, locally advanced unresectable or metastatic solid tumor & a documented HER2 status of:
  • Cohorts 1-6, 11, & 12: HER2 overexpression/amplification
  • Cohorts 7-10 & 13: Known activating HER2 mutations (without overexpression/amplification)
• Subjects must have documented progression after at least one prior therapy (excluding adjuvant/neoadjuvant), and deemed unlikely to benefit from further SOC treatment
• Patients with HER2 overexpressing/amplified mBC or HER2 mutant NSCLC(except where there is co-existing presence of HER2 overexpression/amplification) are excluded
• Patients previously treated with HER2 TKIs are excluded