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

Last updated: July 7, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Recruiting

Phase

1

Condition

Pancreatic Cancer

Stomach Cancer

Colorectal Cancer

Treatment

BI 765049

Clinical Study ID

NCT06882746
1454-0015
2024-519301-36-00
U1111-1316-8363
  • Ages > 18
  • All Genders

Study 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 but no longer than 3 years.

During this time, 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 1 week after the first treatment with the intended dose.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Signed and dated informed consent form (ICF)2/main ICF for all patients describingthe study in accordance with International Council on Harmonisation Good ClinicalPractice (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 incountries 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 ofcolorectal carcinoma (CRC), gastric carcinoma (GC), or pancreatic ductaladenocarcinoma (PDAC).

  • In Europe: Patients with a histologically or cytologically confirmed diagnosis ofCRC.

  • Patients with advanced, unresectable, and/or metastatic disease. Further inclusioncriteria apply.

Exclusion

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 withinthe 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 localtreatment"

  • Patient with known leptomeningeal disease or spinal cord compression due to disease.

  • Patient requiring anticoagulant treatment which cannot be safely interrupted, ifmedically needed for a study procedure (e.g. biopsy) based on the opinion of theInvestigator.

Further exclusion criteria apply.

Study Design

Total Participants: 135
Treatment Group(s): 1
Primary Treatment: BI 765049
Phase: 1
Study Start date:
March 28, 2025
Estimated Completion Date:
May 12, 2027

Connect with a study center

  • Charite Universitätsmedizin Berlin KöR

    Berlin, 10117
    Germany

    Site Not Available

  • Katholisches Klinikum Bochum gGmbH

    Bochum, 44791
    Germany

    Site Not Available

  • Technische Universität Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg, Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

  • Universitätsklinikum Mannheim GmbH

    Mannheim, 68167
    Germany

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Clínico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Virgen de la Victoria

    Málaga, 29010
    Spain

    Site Not Available

  • Hospital Clínico de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Valkyrie Clinical Trials

    Los Angeles, California 90067
    United States

    Active - Recruiting

  • Yale Cancer Center

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

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