A Study to Test Different Doses of BI 765049 in People With Advanced Cancer of the Colon, Rectum, Stomach, or Pancreas
Colon/Rectal Cancer
Stomach/ Gastric Cancer
18 Years and older, Male and Female
1454-0015 (primary)
NCI-2025-03676
2024-519301-36-00
U1111-1316-8363
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.
Eligibility
- For all patients, signed and dated informed consent form (ICF)2/main ICF describing the study in accordance with International Council on Harmonisation Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.
- Patient must be =18 years of age and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature on the ICFs (ICF1/screening ICF and ICF2/main ICF).
- In US: Patients with a histologically or cytologically confirmed diagnosis of colorectal carcinoma (CRC), gastric carcinoma (GC), or pancreatic ductal adenocarcinoma (PDAC).
- In Europe: Patients with a histologically or cytologically confirmed diagnosis of CRC.
- Patients with advanced, unresectable, and/or metastatic disease. Further inclusion criteria apply.
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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