Actively Recruiting
Dose Escalation Trial of BI 765049 in Advanced, Unresectable, or Metastatic Colorectal, Gastric, or Pancreatic Cancer to Determine Maximum Tolerated Dose and Dosing Regimen
Led by Boehringer Ingelheim · Updated on 2026-03-17
135
Participants Needed
3
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating BI 765049 in adults with advanced cancer of the colon, rectum, stomach, or pancreas that cannot be removed by surgery or has spread. This study includes people whose prior treatments were unsuccessful or who have no other treatment options. The main goal is to find the highest dose of BI 765049 that patients can tolerate, as well as the best dose and administration method for further study. BI 765049 may help the immune system fight cancer. Participants receive BI 765049 at least once every 3 weeks and may continue treatment as long as they benefit and can tolerate it. Additional medication is given before and after BI 765049 to help with side effects, and if taken at home, daily phone visits are conducted. The study includes two experimental administration regimens for BI 765049. This is an open-label, non-randomized, phase 1 trial focused on dose escalation. During the study, participants regularly visit the study site, including several overnight hospital stays. Doctors monitor health, perform lab tests, and record any side effects possibly caused by the study drug. The main measure is the occurrence of severe health problems limiting doses during the evaluation period. Secondary measures include treatment response and drug concentration levels. The study may last up to 36 months with ongoing assessments and safety monitoring.
CONDITIONS
Brief Title
A Study to Test Different Doses of BI 765049 in People With Advanced Cancer of the Colon, Rectum, Stomach, or Pancreas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any trial procedures
- Age 18 years or older and legal age of consent where applicable
- Confirmed diagnosis of colorectal carcinoma, gastric carcinoma, or pancreatic ductal adenocarcinoma (criteria vary by region)
- Advanced, unresectable, and/or metastatic disease
- Additional inclusion criteria apply
You will not qualify if you...
- Major surgery within 28 days before first dose of BI 765049
- Previous or other malignancies within last 5 years except effectively treated non-melanoma skin cancer, carcinoma in situ of cervix, ductal carcinoma in situ, or other cured malignancies
- Known leptomeningeal disease or spinal cord compression due to cancer
- Need for anticoagulant treatment that cannot be safely interrupted
- Additional exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months
Participants receive the study drug BI 765049 as part of the treatment for advanced cancer.
Visits occur during dosing and monitoring periods as per protocol
Trial Site Locations
Total: 3 locations
1
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
2
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
Research Team
B
Boehringer Ingelheim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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