Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06882746

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

Led by Boehringer Ingelheim · Updated on 2026-03-17

135

Participants Needed

3

Research Sites

110 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form before any study procedures
  • Age 18 years or older and legal age of consent
  • In US: Diagnosis of colorectal carcinoma, gastric carcinoma, or pancreatic ductal adenocarcinoma confirmed by tissue analysis
  • In Europe: Diagnosis of colorectal carcinoma confirmed by tissue analysis
  • Advanced, unresectable, and/or metastatic disease
Not Eligible

You will not qualify if you...

  • Major surgery within 28 days before first dose of BI 765049
  • Other cancers treated within the last 5 years except certain skin or cervical cancers or ductal carcinoma in situ
  • Known leptomeningeal disease or spinal cord compression due to disease
  • Need for anticoagulant treatment that cannot be safely stopped
  • Further exclusion criteria apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

B

Boehringer Ingelheim

CONTACT

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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