A Study in People With Advanced Cancer to Test How Well Different Doses of BI 3819026 Are Tolerated When Taken Alone and Together With Ezabenlimab

1. Previous or concomitant malignancies other than the one treated in this trial within the last 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

* Other effectively treated malignancy that is considered cured by local treatment

2. Has received prior therapy with an immune-checkpoint inhibitor that was discontinued due to immune-related adverse events (AE)

3. Prior treatment with systemic anti-cancer drugs (including any agents or investigational medicinal products) within 3 weeks or 5 half-lives (whichever is shorter) before the first dose of trial treatment

4. Radiotherapy within 4 weeks prior to start of the trial treatment except as follows:

* Palliative radiotherapy to regions other than the chest is allowed if completed at least 2 weeks prior and is not on the target lesion (which should be outside of the radiation field)

* Single dose palliative radiotherapy for symptomatic metastasis that is not the target lesion (which should be outside of the radiation field) within 2 weeks prior may be allowed

5. Active/previous history of interstitial lung disease, pulmonary fibrosis, organising pneumonia or non-infectious pneumonitis (any grade)

6. Patients with active autoimmune disease or a documented history of autoimmune disease, that requires systemic treatment, e.g. corticosteroids or immunosuppressive drugs, except patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy; patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible

7. Patient has a diagnosis of immunodeficiency other than human immunodeficiency virus (HIV)

8. Patients with history of HIV infection who meet one or more of the following criteria:

* CD4+ count \<350 cells/µL

* Viral load \>400 copies/mL

* Not receiving antiretroviral therapy

* Receiving established antiretroviral therapy for less than four weeks prior to the start of trial treatment

What this study is about