This study is open to adults with different types of advanced cancer. People can take part if previous treatment was not successful, or no treatment exists.
The purpose of this study is to find the highest dose of a medicine called BI 1703880 that people with advanced cancer can tolerate when taken together with ezabenlimab.
BI 1703880 and ezabenlimab are medicines that may help the immune system fight cancer. In this study, BI 1703880 is given to people for the first time.
Participants get BI 1703880 and ezabenlimab as infusions into a vein. During the first 6 weeks, they get BI 1703880 once a week. Later, they get BI 1703880 every 3 weeks. After the first 3 weeks, they get ezabenlimab in addition every 3 weeks.
Participants can get BI 1703880 for up to 1 year and ezabenlimab for up to 2 years as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. At these visits, the doctors check participants' health and take note of any unwanted effects.
Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic or relapsed/refractory solid tumour. Patient must have at least one measurable lesion (according to Response Criteria in Solid Tumours (RECIST 1.1)).
Patient must have exhausted or refused established treatment options for the malignant disease, or is not eligible for established treatment options.
Has a lesion amenable to pre-treatment and on-treatment biopsy and patient consents to both biopsies.
Medically fit and willing to undergo all mandatory trial procedures.
Any investigational or antitumour treatment within 4 weeks or 5 half-life periods prior to the first treatment whichever is shorter.
Prior STING agonist therapy.
Prior intolerability of a anti-programmed cell death protein 1 (PD-1) or anti-programmed cell death ligand 1 (PD-L1) therapy.
History of allergy or hypersensitivity to study agent components.
Sequential
BI 1703880
DrugBI 1703880
Ezabenlimab
DrugEzabenlimab
Occurrence of dose limiting toxicities (DLTs) during the maximum tolerated dose (MTD) evaluation period
Occurrence of DLTs during the on-treatment period
Maximum measured concentration of BI 1703880 in plasma (Cmax)
Area under the concentration-time curve of BI 1703880 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
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