A Study to Test Different Doses of BI 765049 Alone and in Combination With Ezabenlimab in Asian People With Advanced Cancer (Solid Tumours) Positive for B7-H6

Inclusion Criteria:

• Signed and dated, written inform consent form (ICF) (ICF1 for B7-H6 testing for allpatients except those with colorectal cancer (CRC); ICF2 for all patients)describing the study in accordance with International Council on Harmonisation GoodClinical Practice (ICH-GCP) and local legislation prior to any trial-specificprocedures, sampling, or analyses.

• ≥18 years of age at the time of signature on the ICFs (ICF1 and ICF2).

• Histologically or cytologically confirmed diagnosis of an advanced, unresectable,and/or metastatic gastrointestinal cancer, colorectal cancer, pancreatic cancer,liver cancer, head and neck cancer, or lung cancer.

• Disease progression despite conventional treatment, intolerant to or not a candidatefor conventional treatment, or with a tumour for which no conventional treatmentexists.

• Agree to the collection of tumour samples (as slides from archival diagnosticsamples or fresh tumour biopsies) for confirmation of B7-H6 expression at ScreeningVisit 02 for colorectal cancer (CRC) patients or at Screening Visit 01 for all otherpatients.

• Confirmed B7-H6 expression on tumour tissue sample (archived or fresh tumour biopsy)based on central pathology review except for patients diagnosed with advanced ormetastatic colorectal cancer (CRC).

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• At least one evaluable target lesion as defined per response evaluation criteria insolid tumors (RECIST v1.1), outside of the central nervous system (CNS), separatefrom any lesion(s) identified for tumour biopsy. Tumour lesions that have beenirradiated ≥28 days before the start of treatment, and have subsequently haddocumented progression, may be chosen as target lesions only in the absence ofmeasurable lesions that have not been irradiated.

• Further inclusion criteria apply

Exclusion Criteria:

• History of a major surgery within 28 days prior to first dose of BI 765049 (majoraccording to the Investigator's assessment).

• Presence of other active invasive cancers other than the one treated in this trialwithin 3 years prior to screening, except for appropriately treated basal cellcarcinoma of the skin, in situ carcinoma of the uterine cervix, or other localtumours considered cured by local treatment.

• Known leptomeningeal disease or spinal cord compression due to disease.

• Require anticoagulant treatment which cannot be safely interrupted, if medicallyneeded for a study procedure (e.g., biopsy) based on the opinion of theInvestigator.

• Any of the following laboratory evidence of hepatitis virus infection. Test resultsobtained in routine diagnostics are acceptable for screening if done within 14 daysbefore the ICF2 date: positive results of hepatitis B surface (HBs) antigen,presence of hepatitis B core (HBc) antibody together with hepatitis B virus (HBV)-DNA and presence of hepatitis C-RNA

• Infection requiring systemic antimicrobial, antiviral, antiparasitic, or antifungaltherapy at the start of treatment in the trial unless otherwise stipulated.

• Patients with history of human immunodeficiency virus (HIV) infection who meet oneor more of the following criteria: cluster of differentiation 4 (CD4)+ count <350cells/μL, viral load >400 copies/μL, not receiving antiretroviral therapy, receivingestablished antiretroviral therapy for less than four weeks prior to the start ofstudy treatment, and history of AIDS-defining opportunistic infections within 12months prior to start of study treatment. Patients with a history of HIV who do notmeet any of the criteria above are eligible to participate, but the patient must beunder the care of a HIV/Infectious Diseases specialist, or a HIV/Infectious Diseasesspecialist must be consulted prior to inclusion.

• Previous treatment history: previous treatment in this trial or another trial with aB7-H6 targeting agent, treatment with a systemic anti-cancer therapy orinvestigational drug within 21 days or 5 half-lives (whichever is shorter) of thefirst administration of BI 765049, and treatment with extensive field radiotherapyincluding whole brain irradiation within14 days prior to first administration of BI

• Further exclusion criteria apply