Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations

inclusion criteria:

• Signed and dated written informed consent in accordance with International Councilfor Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior toadmission to the trial.

• Patients ≥18 years old or over the legal age of consent in countries where that isgreater than 18 years at the time of signature of the Informed consent form (ICF).

• Documented (previously established by local testing) Human epidermal growth factorreceptor 2 (HER2) status of:

• HER2 overexpression/amplification

• Known activating HER2 mutations

• An archival (enrolment) tumour tissue sample must be submitted after inclusion ofthe patient to retrospectively confirm the HER2 status (enrolment tissue sample). Ifno archival tissue is available, this may be acceptable in exceptional cases afterwritten agreement with the sponsor. Please note that sample must not be from an areairradiated prior to the biopsy.

• Patient with histologically or cytologically confirmed locally advanced unresectableor metastatic solid tumour who has had at least one prior line of therapy formetastatic disease. In the opinion of the Investigator, patients must be unlikely totolerate or derive clinically meaningful benefit from further standard of caretherapy known to prolong survival.

Further inclusion criteria apply.

exclusion criteria:

• Diagnosis of HER2 mutant Non-small cell lung cancer (NSCLC)

• Previous or concomitant malignancies other than the 1 treated in this trial withinthe previous 3 years except:

• effectively treated non-melanoma skin cancers

• effectively treated carcinoma in situ of the cervix

• effectively treated ductal carcinoma in situ of the breast

• localised prostate cancer on watchful waiting or active surveillance

• other effectively treated malignancy that is considered cured by localtreatment.

• Patients who must or wish to continue the intake of restricted medications or anydrug considered likely to interfere with the safe conduct of the trial

• Not completely recovered from major surgery (major according to the investigator'sassessment) performed prior to screening or planned within 6 months after screening,e.g. hip replacement Further exclusion criteria apply.