Summary
This study is open to adults with advanced cancer of the colon, rectum, stomach, or
pancreas, that is the cancer cannot be removed by surgery or has spread. People can take
part in this study if their previous treatment was not successful, or no other treatment
exists.
The study aims to find the highest dose for the study medicine called BI 765049 that
people with advanced cancer can tolerate. Another purpose is to find the most suitable
dose and best way of administration of BI 765049 for further clinical development. BI
765049 may help the immune system fight cancer.
Participants receive BI 765049 at least once every 3 weeks. Participants may continue to
get BI 765049 treatment as long as they benefit from treatment and can tolerate it.
Participants in this study also get additional medication before and after treatment with
BI 765049 for better tolerability. If participants take this medication at home, they
have daily phone visits.
Participants regularly visit the study site. The study visits include several overnight
stays at the hospital. At the visits, study doctors check participants' health, take
necessary laboratory tests, and note any unwanted effects. Unwanted effects are any
health problems that the doctors think were caused by the study medicine or treatment. To
find the highest dose of BI 765049 that participants can tolerate, researchers look at
the number of participants with certain severe health problems. These are severe health
problems that happen within the time from when a person first receives the intended
target dose, until one week after they receive it for the second time.