RecruitingPhase 1NCT06882746

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

A Phase I, Open-label, Non-randomised, Multi-center Dose Escalation Trial of BI 765049 Administered by Parenteral Route in Patients With Advanced, Unresectable, and/or Metastatic Colorectal Carcinoma (CRC), Gastric Carcinoma (GC), or Pancreatic Ductal Adenocarcinoma (PDAC) to Determine the MTD and the RP2D and to Determine the Dosing Regimen for Further Development of BI 765049


Sponsor

Boehringer Ingelheim

Enrollment

135 participants

Start Date

Mar 28, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing different doses of a new experimental drug called BI 765049 in people whose colorectal (colon or rectal), stomach, or pancreatic cancer has spread or cannot be removed with surgery. The goal is to find the safest and most effective dose. **You may be eligible if...** - You are 18 or older - You have been diagnosed with advanced colorectal cancer, gastric (stomach) cancer, or pancreatic ductal adenocarcinoma (a type of pancreatic cancer) — confirmed by biopsy - Your cancer cannot be surgically removed or has spread **You may NOT be eligible if...** - You had major surgery within the past 28 days - You have had another cancer in the past 5 years (with limited exceptions for fully treated cancers) - You have cancer that has spread to the lining of the brain or is compressing the spinal cord - You require blood thinners that cannot be safely paused if needed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBI 765049

BI 765049


Locations(3)

Valkyrie Clinical Trials

Los Angeles, California, United States

Winship Cancer Institute

Atlanta, Georgia, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

View Full Details on ClinicalTrials.gov

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NCT06882746


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