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Study of BI 3819026 Alone and With Ezabenlimab for Advanced Cancer

This study is for adults with advanced or metastatic solid cancers that have progressed or are not suitable for standard treatments. It aims to find the highest dose of BI 3819026 that can be safely tolerated, both when given alone and when combined with another study medicine called ezabenlimab. Both BI 3819026 and ezabenlimab are being studied for their potential to fight cancer by targeting the RAF mechanism. Participants will first receive BI 3819026 alone, then in combination with ezabenlimab. Doses of BI 3819026 will gradually increase in small groups, with safety being the main focus. The study plans to enroll about 60 people, but its current recruitment status is unclear.

Study design
This is an interventional study with an unspecified phase, enrolling about 60 participants. It tests different doses of BI 3819026 alone and in combination with ezabenlimab.
What's involved
Participants will first receive BI 3819026 alone, then in combination with ezabenlimab. They will remain on the same dose of BI 3819026 throughout the study.
Compensation
Not stated in the trial record.
Follow-up
The primary safety measure, dose-limiting toxicities (DLTs), is evaluated for up to 30 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07607678

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Boehringer Ingelheim
~60 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:BI 3819026Ezabenlimab (BI 754091)

At a glance

Recruiting sites
7 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of dose-limiting toxicities (DLTs) in the primary DLT evaluation period
Measured over Up to 30 days

Conditions

Advanced Solid Cancer
Metastatic Solid Cancer

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Solid Neoplasm

NCT07607678

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Clínica Universidad de Navarra

    Pamplona, Spainstudy coordinator listed

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jerseystudy coordinator listed

    Not yet recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, Spainstudy coordinator listed

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spainstudy coordinator listed

    Recruiting

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, Japanstudy coordinator listed

    Recruiting

  • National Cancer Center Hospital East

    Chiba, Kashiwa, Japanstudy coordinator listed

    Recruiting

  • New York University Langone Medical Center

    New York, New Yorkstudy coordinator listed

    Not yet recruiting

  • SCRI Oncology Partners

    Nashville, Tennesseestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Boehringer Ingelheim
[email protected]
1-800-243-0127
Email the study team

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Eligibility criteria

Inclusion

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)

Exclusion

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

What this trial measures

  • Occurrence of dose-limiting toxicities (DLTs) in the primary DLT evaluation periodUp to 30 days