A Study to Test Different Doses of BI 765049 in People With Advanced Cancer of the Colon, Rectum, Stomach, or Pancreas

Launched by BOEHRINGER INGELHEIM · Mar 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called BI 765049, which may help the immune system fight advanced cancers of the colon, rectum, stomach, or pancreas. The goal is to find the highest dose of this medicine that patients can tolerate without severe side effects. The trial is open to adults aged 18 and older who have advanced cancer that cannot be removed by surgery and have not had success with previous treatments. Participants will receive the study medicine at least once every three weeks and can continue treatment as long as it is helping them, up to a maximum of three years.

If you decide to participate, you'll need to visit the study site regularly, which may include some overnight stays at the hospital. During these visits, doctors will monitor your health, conduct tests, and check for any side effects related to the treatment. To ensure safety, researchers will closely observe any serious health problems that might occur after you start the treatment. It's important to understand that there are specific criteria for eligibility, including having a confirmed diagnosis of the eligible cancers and not having certain other health conditions. If you are interested, talk to your healthcare provider to see if this study might be right for you.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Signed and dated informed consent form (ICF)2/main ICF for all patients 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.
• Exclusion criteria:
• • Patient with a history of a major surgery within 28 days prior to first dose of BI 765049 (major according to the Investigator's and/or Medical Monitor's assessment).
• * Previous or concomitant malignancies other than the one treated in this trial within the last 5 years except:
• • Effectively treated non-melanoma skin cancers
• • Effectively treated carcinoma in situ of the cervix
• • Effectively treated ductal carcinoma in situ
• • Other effectively treated malignancy that is considered cured by local treatment"
• • Patient with known leptomeningeal disease or spinal cord compression due to disease.
• • Patient requiring anticoagulant treatment which cannot be safely interrupted, if medically needed for a study procedure (e.g. biopsy) based on the opinion of the Investigator.
• • Further exclusion criteria apply.