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Gastrointestinal CancerPhase 1NCT06091930

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

A Phase 1 study testing BI 765049 and Ezabenlimab in people with Gastrointestinal Cancer and Lung Cancer, run by Boehringer Ingelheim at 3 sites in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BI 765049 and Ezabenlimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
3 sitesJapan
Study dates
16 Feb 2024to 2 Feb 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed and dated, written inform consent form (ICF) (ICF1 for B7-H6 testing for all patients except those with colorectal cancer (CRC); ICF2 for all patients) describing the study in accordance with International Council on Harmonisation Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, 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 candidate for conventional treatment, or with a tumour for which no conventional treatment exists.
  • Agree to the collection of tumour samples (as slides from archival diagnostic samples or fresh tumour biopsies) for confirmation of B7-H6 expression at Screening Visit 02 for colorectal cancer (CRC) patients or at Screening Visit 01 for all other patients.
  • Confirmed B7-H6 expression on tumour tissue sample (archived or fresh tumour biopsy) based on central pathology review except for patients diagnosed with advanced or metastatic colorectal cancer (CRC).
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • At least one evaluable target lesion as defined per response evaluation criteria in solid tumors (RECIST v1.1), outside of the central nervous system (CNS), separate from any lesion(s) identified for tumour biopsy. Tumour lesions that have been irradiated ≥28 days before the start of treatment, and have subsequently had documented progression, may be chosen as target lesions only in the absence of measurable lesions that have not been irradiated.
  • Further inclusion criteria apply

Who cannot join

  • History of a major surgery within 28 days prior to first dose of BI 765049 (major according to the Investigator's assessment).
  • Previous or concomitant malignancies other than the one treated in this trial within the 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 local treatment
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  • Known leptomeningeal disease or spinal cord compression due to disease.
  • Require anticoagulant treatment which cannot be safely interrupted, if medically needed for a study procedure (e.g., biopsy) based on the opinion of the Investigator.
  • 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: positive results 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 days prior to first dose of trial medication. Patients who have any clinical signs of infection (e.g. fever or leukocytosis) within 48 hours prior to first dose of trial medication are not eligible.
  • Patients with known history of human immunodeficiency virus (HIV) infection who meet one 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 to the start of study treatment
  • History of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months prior to start of study treatment Patients with a history of HIV who do not meet any of the criteria above are eligible to participate, but the patient must be under the care of a HIV/Infectious Diseases specialist, or a HIV/Infectious Diseases specialist must be consulted prior to inclusion.
  • Further exclusion criteria apply

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045

  • Japanese Foundation for Cancer Research

    Tokyo, Koto-ku, 135-8550

Other trials in Japan

About this study

Official title: Phase I, Non-randomised, Open-label, Multi-centre Dose Escalation and Expansion Trial of BI 765049 and BI 765049 + Ezabenlimab Administered by Repeated Intravenous Infusion in Asian Patients With Malignant Solid Tumours Expressing B7-H6

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.

Read more

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.

Being tested
BI 765049, Ezabenlimab
Medical subject headings
Gastrointestinal Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 765049Drug

    BI 765049

  • EzabenlimabDrug

    Also called BI 754091

    Ezabenlimab

Study groups in NCT06091930
Study groupRoleWhat they receive
Part I: BI 765049ExperimentalBI 765049 monotherapy - dose escalation
Receives: Drug: BI 765049
Part II: BI 765049ExperimentalBI 765049 monotherapy - dose expansion
Receives: Drug: BI 765049
Part III: BI 765049 + ezabenlimabExperimentalBI 765049 + ezabenlimab combination therapy - dose escalation
Receives: Drug: BI 765049; Drug: Ezabenlimab
Part IV: BI 765049 + ezabenlimabExperimentalBI 765049 + ezabenlimab combination therapy - dose expansion
Receives: Drug: BI 765049; Drug: Ezabenlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part I: Occurrence of dose-limiting toxicity (DLTs) during the maximum tolerated dose (MTD) evaluation period for BI 765049 monotherapy

    Measured: One treatment cycle, defined as 3 weeks after first administration of BI 765049 or 1 week after the administration of first full dose of BI 765049, whichever is longer

  2. Part II: Objective response based on the response evaluation criteria in solid tumors (RECIST v1.1)

    Objective response will be determined by the Investigator in patients with measurable disease and will be defined as the best overall response of complete response (CR) or partial response (PR), from the first administration of trial medication until the earliest of progressive disease (PD), death, last evaluable tumour assessment before the start of subsequent anti-cancer therapy, lost to follow-up, or withdrawal of consent.

    Measured: Up to month 36

  3. Part III: Occurrence of dose-limiting toxicity (DLTs) during the maximum tolerated dose (MTD) evaluation period for BI 765049 in combination with ezabenlimab

    Measured: From first BI 765049 administration to 1 week after the first ezabenlimab dose

  4. Part IV: Objective response based on the response evaluation criteria in solid tumors (RECIST v1.1)

    Measured: Up to month 36

Secondary outcomes (26)

  1. Part I: Maximum measured concentration of BI 765049 (Cmax) after first administration

    Measured: Up to 1 day

  2. Part I: Maximum measured concentration of BI 765049 (Cmax) after multiple administrations

    Measured: Up to month 37

  3. Part III: Maximum measured concentration of BI 765049 (Cmax) after the first administration

    Measured: Up to 1 day

  4. Part III: Maximum measured concentration of BI 765049 (Cmax) after multiple administrations

    Measured: Up to month 37

  5. Part I: Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ) after the first administration

    Measured: Up to 1 day

  6. Part I: Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ) after multiple administrations

    Measured: Up to month 37

  7. Part III: Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ) after the first administration

    Measured: Up to 1 day

  8. Part III: Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ) after multiple administrations

    Measured: Up to month 37

  9. Part I: Objective response based on the response evaluation criteria in solid tumors (RECIST v1.1)

    Objective response will be determined by the Investigator in patients with measurable disease who have been treated with either BI 765049 monotherapy or BI 765049 in combination with ezabenlimab and will be defined as the best overall response of complete response (CR) or partial response (PR), according to response evaluation criteria in solid tumors (RECIST v1.1). from the first administration of trial medication until the earliest of progressive disease (PD), death, or last evaluable tumour assessment before the start of subsequent anti-cancer therapy, lost to follow-up, or withdrawal of consent.

    Measured: Up to month 36

  10. Part III: Objective response based on the response evaluation criteria in solid tumors (RECIST v1.1)

    Measured: Up to month 36

  11. Part II: Progression free survival (PFS)

    Progression free survival (PFS) will be defined as the time from first treatment administration until tumour progression according to response evaluation criteria in solid tumors (RECIST v1.1) as determined by the Investigator or death from any cause, whichever occurs earlier.

    Measured: Up to month 36

  12. Part IV: Progression free survival (PFS)

    Measured: Up to month 36

  13. Part II: Duration of response

    Duration of response will be defined as the time from a patient's first documented complete response (CR) or partial response (PR), according to response evaluation criteria in solid tumors (RECIST v1.1), until the earliest of disease progression, or death.

    Measured: Up to month 36

  14. Part IV: Duration of response

    Measured: Up to month 36

  15. Part II: Disease control

    Disease control will be defined as best overall response of complete response (CR), partial response (PR) or stable disease (SD) where best overall response is as determined by the Investigator according to response evaluation criteria in solid tumors (RECIST v1.1) from the first administration of trial medication until the earliest of progression disease (PD), death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, lost to follow-up, or withdrawal of consent.

    Measured: Up to month 36

  16. Part IV: Disease control

    Measured: Up to month 36

  17. Part II: Objective response based on the immune response evaluation criteria in solid tumors (iRECIST)

    Objective response based on immune response evaluation criteria in solid tumors (iRECIST) criteria will be determined by the Investigator in patients with measurable disease and will be defined as the best overall response of complete response (CR) or partial response (PR), from the first administration of trial medication until the earliest of immune confirmed progressive disease (PD), death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, lost to follow-up, or withdrawal of consent.

    Measured: Up to month 36

  18. Part IV: Objective response based on the immune response evaluation criteria in solid tumors (iRECIST)

    Measured: Up to month 36

  19. Part II: Maximum measured concentration of BI 765049 (Cmax) after first administration

    Measured: Up to 1 day

  20. Part II: Maximum measured concentration of BI 765049 (Cmax) after multiple administrations

    Measured: Up to month 37

  21. Part IV: Maximum measured concentration of BI 765049 (Cmax) after first administration

    Measured: Up to 1 day

  22. Part IV: Maximum measured concentration of BI 765049 (Cmax) after multiple administrations

    Measured: Up to month 37

  23. Part II: Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ) after first administration

    Measured: Up to 1 day

  24. Part II: Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ) after multiple administrations

    Measured: Up to month 37

  25. Part IV: Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ) after first administration

    Measured: Up to 1 day

  26. Part IV: Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ) after multiple administrations

    Measured: Up to month 37

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start16 Feb 2024
  3. Primary completion15 Aug 2025
  4. Study completion2 Feb 2026

Why it stopped: Sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
The trial is divided in four parts. Part I and Part III will have a sequential assignment while Part II and Part IV will have a parallel assignment.
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06091930
Sponsor's protocol ID
1454-0004
Status last verified
Oct 2026
First submitted
16 Oct 2023
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 765049 and Ezabenlimab in people with Gastrointestinal Cancer and Lung Cancer, run by Boehringer Ingelheim at 3 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part I: Occurrence of dose-limiting toxicity (DLTs) during the maximum tolerated dose (MTD) evaluation period for BI 765049 monotherapy (time frame: One treatment cycle, defined as 3 weeks after first administration of BI 765049 or 1 week after the administration of first full dose of BI 765049, whichever is longer). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06091930.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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