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RecruitingNCT07607678Updated Sep 29, 2026

A Study in People With Advanced Cancer to Test How Well Different Doses of BI 3819026 Are Tolerated When Taken Alone and Together With Ezabenlimab

A Phase 1 interventional study of BI 3819026 and Ezabenlimab (BI 754091) in Advanced Solid Cancer and Metastatic Solid Cancer, sponsored by Boehringer Ingelheim. Recruiting at 9 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is open to adults with advanced cancer. The purpose of this study is to find the highest dose of BI 3819026 that people with advanced cancer can tolerate when taken alone and together with ezabenlimab. BI 3819026 and ezabenlimab are study medicines that may fight cancer.

Participants first receive one treatment of BI 3819026 alone, followed by treatment with a combination of BI 3819026 and ezabenlimab. Different doses of BI3819026 are given to small groups of participants, starting with the lowest dose. Treatment with the next higher dose of BI 3819026 starts only if the previous dose was tolerated. Each participant remains on the same dose of BI 3819026 throughout the study.

Participants are in the study for up to 2 years as long as they can tolerate the treatment and their condition does not get worse. During this time, they visit the study site regularly. The doctors look at the occurrence of certain health problems. They also regularly take blood samples, image participants' tumours, and take note of any unwanted effects.

02

Conditions studied

  • Advanced Solid Cancer
  • Metastatic Solid Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Participants with histologically confirmed unresectable advanced or metastatic solid tumours who have documented progression after or are refractory to or ineligible for established and available therapies with proven clinical benefit, or have declined such therapy.
  2. At least one measurable disease lesion outside of the central nervous system (CNS) defined per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
  3. Patients with brain metastases are eligible provided they meet the following criteria:

    • Brain metastases have adequately been treated and are without progression or haemorrhage and are considered stable and asymptomatic by the investigator,
    • Radiotherapy and/or surgery for brain metastases was completed at least 14 and 28 days, respectively, prior to the first administration of BI 3819026,
    • Patient is off steroids and anti-convulsive drugs for at least 7 days prior to the first administration of BI 3819026 and has no requirement for such therapy at the time of initiating trial treatment.
  4. Availability of archived formalin-fixed and paraffin embedded (FFPE) tumour tissue. Patients who do not have archived FFPE tumour tissue available may be allowed to enrol without archival tumour tissue upon agreement between the investigator and the Sponsor
  5. All toxicities related to previous anti-cancer therapies have resolved to Grade ≤1 or baseline prior to trial treatment administration (except for alopecia, peripheral neuropathy and endocrinopathies considered irreversible [like hypothyroidism], and amenorrhea/menstrual disorders which can be any grade)
  6. Adequate liver, bone marrow and renal organ function Further inclusion criteria apply.

Exclusion criteria

Exclusion Criteria :

  1. 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 of the breast
    • Other effectively treated malignancy that is considered cured by local treatment
  2. Has received prior therapy with an immune-checkpoint inhibitor that was discontinued due to immune-related adverse events (AE)
  3. Prior treatment with systemic anti-cancer drugs (including any agents or investigational medicinal products) within 3 weeks or 5 half-lives (whichever is shorter) before the first dose of trial treatment
  4. Radiotherapy within 4 weeks prior to start of the trial treatment except as follows:

    • Palliative radiotherapy to regions other than the chest is allowed if completed at least 2 weeks prior and is not on the target lesion (which should be outside of the radiation field)
    • Single dose palliative radiotherapy for symptomatic metastasis that is not the target lesion (which should be outside of the radiation field) within 2 weeks prior may be allowed
  5. Active/previous history of interstitial lung disease, pulmonary fibrosis, organising pneumonia or non-infectious pneumonitis (any grade)
  6. Patients with active autoimmune disease or a documented history of autoimmune disease, that requires systemic treatment, e.g. corticosteroids or immunosuppressive drugs, except patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy; patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible
  7. Patient has a diagnosis of immunodeficiency other than human immunodeficiency virus (HIV)
  8. Patients with history of HIV infection who meet one or more of the following criteria:

    • CD4+ count \<350 cells/µL
    • Viral load >400 copies/mL
    • Not receiving antiretroviral therapy
    • Receiving established antiretroviral therapy for less than four weeks prior to the start of trial treatment
    • History of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months prior to start of trial treatment Patients with a history of HIV who do not meet any of the exclusion criteria above are eligible to participate but the patient must be under the care of an HIV/Infectious Diseases specialist, or an HIV/Infectious Diseases specialist must be consulted prior to inclusion Further exclusion criteria apply.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    BI 3819026 + Ezabenlimab (BI 754091) dose group 1

    Dose escalation

    Drug: BI 3819026 · Drug: Ezabenlimab (BI 754091)

  • Experimental
    BI 3819026 + Ezabenlimab (BI 754091) dose group 2

    Dose escalation

    Drug: BI 3819026 · Drug: Ezabenlimab (BI 754091)

  • Experimental
    BI 3819026 + Ezabenlimab (BI 754091) dose group 3

    Dose escalation

    Drug: BI 3819026 · Drug: Ezabenlimab (BI 754091)

  • Experimental
    BI 3819026 + Ezabenlimab (BI 754091) dose group 4

    Dose escalation

    Drug: BI 3819026 · Drug: Ezabenlimab (BI 754091)

  • Experimental
    BI 3819026 + Ezabenlimab (BI 754091) dose group 5

    Dose escalation

    Drug: BI 3819026 · Drug: Ezabenlimab (BI 754091)

  • Experimental
    BI 3819026 + Ezabenlimab (BI 754091) dose group 3 backfill

    Drug: BI 3819026 · Drug: Ezabenlimab (BI 754091)

  • Experimental
    BI 3819026 + Ezabenlimab (BI 754091) dose group 4 backfill

    Drug: BI 3819026 · Drug: Ezabenlimab (BI 754091)

  • Experimental
    BI 3819026 + Ezabenlimab (BI 754091) dose group 5 backfill

    Drug: BI 3819026 · Drug: Ezabenlimab (BI 754091)

Interventions

  • DrugBI 3819026

    BI 3819026

  • DrugEzabenlimab (BI 754091)

    Ezabenlimab (BI 754091)

05

What researchers measure

Primary outcomes

  1. Occurrence of dose-limiting toxicities (DLTs) in the primary DLT evaluation period

    Time frame: Up to 30 days

Secondary outcomes

  1. Occurrence of adverse events (AEs) with onset during the on-treatment period

    Time frame: Up to 2 years

  2. Occurrence of DLTs with onset during the on-treatment period

    Time frame: Up to 2 years

  3. Occurrence of AEs with onset during Cycle 1

    Time frame: Up to 15 days

  4. Occurrence of DLTs with onset during Cycle 1

    Time frame: Up to 15 days

  5. Maximum measured concentration of BI 3819026 alone (C max) in cycle 1

    Time frame: Up to 15 days

  6. Maximum measured concentration of BI 3819026 alone (C max) in cycle 3

    Time frame: Up to Day 30

  7. Maximum measured concentration of BI 3819026 + ezabenlimab combination (C max) in cycle 3

    Time frame: Up to Day 30

  8. Area under concentration-time curve of BI 3819026 alone over a uniform dosing interval 0 - 504 h (AUC 0-504) in cycle 1

    Time frame: Up to 15 days

  9. Area under concentration-time curve of BI 3819026 alone over a uniform dosing interval 0 - 504 h (AUC 0-504) in cycle 3

    Time frame: Up to Day 30

  10. Area under concentration-time curve of BI 3819026 + ezabenlimab combination over a uniform dosing interval 0 - 504 h (AUC 0-504) in cycle 3

    Time frame: Up to Day 30

  11. Treatment-induced changes in target cells as compared with baseline

    Backfill cohorts only: only patients in whom sequential biopsies are technically feasible and deemed safe by the investigator will be eligible

    Time frame: At baseline and up to 2 years

  12. Treatment-induced changes in target cells ratio as compared with baseline

    Backfill cohorts only

    Time frame: At baseline and up to 2 years

06

Study locations

8 of 9 sites recruiting
  • Yale Cancer Center
    New Haven, Connecticut 06511, United States
    Recruiting
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
    Recruiting
  • New York University Langone Medical Center
    New York, New York 10016, United States
    Not yet recruiting
  • SCRI Oncology Partners
    Nashville, Tennessee 37203, United States
    Recruiting
  • National Cancer Center Hospital East
    Chiba, Kashiwa, 277-8577, Japan
    Recruiting
  • National Cancer Center Hospital
    Tokyo, Chuo-ku, 104-0045, Japan
    Recruiting
  • Hospital Universitari Vall d'Hebron
    Barcelona, 08035, Spain
    Recruiting
  • Clínica Universidad de Navarra
    Pamplona, 31008, Spain
    Recruiting
  • Hospital Clinico Universitario de Valencia
    Valencia, 46010, Spain
    Recruiting
07

References and documents

Related links

Individual participant data

Plan to share: Yes — Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Supporting information: Study protocol, Sap, Csr

08

Registry details

Key details

Study ID
NCT07607678
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
May 26, 2026
Start date
May 1, 2026
Primary completion
Jun 5, 2028 (estimated)
Completion
Oct 15, 2030 (estimated)
Last update
Sep 29, 2026

Study contacts

Boehringer Ingelheim
Contact
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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