Status:
ACTIVE_NOT_RECRUITING
A Study to Test Different Doses of BI 765049 in People With Advanced Cancer of the Colon, Rectum, Stomach, or Pancreas
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Colorectal Carcinoma
Gastric Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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 based on the opinion of the Investigator.
- Further exclusion criteria apply.
Exclusion
Key Trial Info
Start Date :
March 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 12 2027
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT06882746
Start Date
March 28 2025
End Date
May 12 2027
Last Update
December 9 2025
Active Locations (3)
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1
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
2
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
3
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601