Zongertinib for Advanced Cancers with HER2 Alterations

Inclusion criteria: * Patients aged ≥18 years * Documented Human epidermal growth factor receptor 2 (HER2)-positive status or known activating HER2 mutations (by local testing) * Histologically or cytologically confirmed locally advanced, unresectable, or metastatic solid tumours * Disease progression following prior treatment in the metastatic setting (including treatment with antibody-drug conjugates (ADCs)) and no suitable standard of care treatment options * Availability of archival tumour tissue sample to confirm HER2 status * Presence of ≥1 measurable lesion outside the central nervous system (CNS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (investigator assessed) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Further inclusion criteria apply. Exclusion criteria: * Diagnosis of HER2-positive (overexpressed/amplified) metastatic breast cancer * Diagnosis of HER2-mutant non-small cell lung cancer (NSCLC) * Previous treatment with any HER2 tyrosine kinase inhibitors (TKIs) * Previous or concomitant malignancies other than the one treated in this trial within the previous 3 years except the following effectively treated cancers: nonmelanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, localized prostate cancer on watchful waiting or active surveillance, and other effectively treated malignancies that are considered cured by local treatment * Uncontrolled or symptomatic brain or subdural metastases during screening * Known diagnosis of leptomeningeal disease * Intake of restricted medications or any drug considered likely to interfere with the trial being conducted in a safe mannerFurther exclusion criteria apply.