A Study to Test Different Doses of BI 765049 Alone and in Combination With Ezabenlimab in Asian People With Advanced Cancer (Solid Tumours) Positive for B7-H6

Last updated: June 24, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Recruiting

Phase

1

Condition

Lung Disease

Nasopharyngeal Cancer

Liver Cancer

Treatment

Ezabenlimab

BI 765049

Clinical Study ID

NCT06091930
1454-0004
  • Ages > 18
  • All Genders

Study Summary

This is a study in adults from Asia with different types of advanced cancer (solid tumours). People can join the study if they have cancer of the stomach, large bowel and rectum, pancreas, liver, head and neck or non-small cell lung cancer. This is a study for people for whom previous treatment was not successful or no treatment exists. People can participate if their tumour has the B7-H6 marker.

The purpose of this study is to find the highest dose of BI 765049 that people with advanced cancer can tolerate when taken (alone and) together with ezabenlimab. Another purpose is to check whether BI 765049 taken (alone and) together with ezabenlimab can make tumours shrink. Both medicines may help the immune system fight cancer.

Participants can stay in the study up to 3 years, as long as they can tolerate it and can benefit from it. During this time, they visit the study site about every 3 weeks. At the study site they get BI 765049 alone or in combination with ezabenlimab as an infusion into a vein. BI 765049 is given in 3-week cycles, ezabenlimab is given once every 3 weeks.

The doctors check the health of the participants and note any health problems that could have been caused by BI 765049 or ezabenlimab. Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed and dated, written inform consent form (ICF) (ICF1 for B7-H6 testing for allpatients except those with colorectal cancer (CRC); ICF2 for all patients)describing the study in accordance with International Council on Harmonisation GoodClinical Practice (ICH-GCP) and local legislation prior to any trial-specificprocedures, sampling, or analyses.

  • ≥18 years of age at the time of signature on the ICFs (ICF1 and ICF2).

  • Histologically or cytologically confirmed diagnosis of an advanced, unresectable,and/or metastatic gastrointestinal cancer, colorectal cancer, pancreatic cancer,liver cancer, head and neck cancer, or lung cancer.

  • Disease progression despite conventional treatment, intolerant to or not a candidatefor conventional treatment, or with a tumour for which no conventional treatmentexists.

  • Agree to the collection of tumour samples (as slides from archival diagnosticsamples or fresh tumour biopsies) for confirmation of B7-H6 expression at ScreeningVisit 02 for colorectal cancer (CRC) patients or at Screening Visit 01 for all otherpatients.

  • Confirmed B7-H6 expression on tumour tissue sample (archived or fresh tumour biopsy)based on central pathology review except for patients diagnosed with advanced ormetastatic colorectal cancer (CRC).

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  • At least one evaluable target lesion as defined per response evaluation criteria insolid tumors (RECIST v1.1), outside of the central nervous system (CNS), separatefrom any lesion(s) identified for tumour biopsy. Tumour lesions that have beenirradiated ≥28 days before the start of treatment, and have subsequently haddocumented progression, may be chosen as target lesions only in the absence ofmeasurable lesions that have not been irradiated.

  • Further inclusion criteria apply

Exclusion

Exclusion Criteria:

  • History of a major surgery within 28 days prior to first dose of BI 765049 (majoraccording to the Investigator's assessment).

  • Previous or concomitant malignancies other than the one treated in this trial withinthe last 3 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

  • Known leptomeningeal disease or spinal cord compression due to disease.

  • Require anticoagulant treatment which cannot be safely interrupted, if medicallyneeded for a study procedure (e.g., biopsy) based on the opinion of theInvestigator.

  • Hepatitis C virus (HCV) infection, defined as:

  • Currently receiving curative antiviral treatment for HCV infection, and/or

  • HCV viral load is above the limit of quantification (HCV Ribonucleic acid (RNA)positive)

  • Hepatitis B virus (HBV) infection with the following laboratory evidence: positiveresults of hepatitis B surface (HBs) antigen and presence of Hepatitis B core (HBc)antibody together with HBV-deoxyribonucleic acid (DNA).

  • Presence of any infection requiring systemic antimicrobial treatment within 7 daysprior to first dose of trial medication. Patients who have any clinical signs ofinfection (e.g. fever or leukocytosis) within 48 hours prior to first dose of trialmedication are not eligible.

  • Patients with known history of human immunodeficiency virus (HIV) infection who meetone or more of the following criteria:

  • Cluster of differentiation 4 (CD4+) count <350 cells/μL (local lab assessment)

  • Viral load >400 copies/mL (local lab assessment)

  • Not receiving antiretroviral therapy

  • Receiving established antiretroviral therapy for less than four weeks prior tothe start of study treatment

  • History of acquired immunodeficiency syndrome (AIDS)-defining opportunisticinfections within 12 months prior to start of study treatment Patients with ahistory of HIV who do not meet any of the criteria above are eligible toparticipate, but the patient must be under the care of a HIV/InfectiousDiseases specialist, or a HIV/Infectious Diseases specialist must be consultedprior to inclusion.

  • Further exclusion criteria apply

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Ezabenlimab
Phase: 1
Study Start date:
February 16, 2024
Estimated Completion Date:
February 11, 2027

Connect with a study center

  • Shandong Cancer Hospital

    Jinan, 250117
    China

    Site Not Available

  • Shanghai East Hospital

    Shanghai, 200120
    China

    Site Not Available

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577
    Japan

    Active - Recruiting

  • Kansai Medical University Hospital

    Osaka, Hirakata, 573-1191
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045
    Japan

    Active - Recruiting

  • Japanese Foundation for Cancer Research

    Tokyo, Koto-ku, 135-8550
    Japan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10048
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

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