Testing how well different doses of BI 3819026 can be tolerated alone and with ezabenlimab in advanced cancer
Official title: A First-in-human Phase I, Open-label, Multicentre, Dose Escalation Trial of BI 3819026 in Combination With Ezabenlimab in Patients With Unresectable Advanced or Metastatic Solid Cancers to Determine the Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE)
Run by Boehringer Ingelheim · NCT07607678 · Data updated 2026-11-12
This study tests whether varying doses of BI 3819026 can be tolerated by adults with advanced solid cancers, both by itself and in combination with ezabenlimab.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Boehringer Ingelheim Industry-sponsored |
| Drugs / interventions | radiation, ezabenlimab |
| Locations | 9 sites (New Haven, Connecticut and 8 other locations) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | June 5, 2028 |
| Study ends | October 15, 2030 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07607678 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with histologically confirmed unresectable advanced or metastatic solid tumors and at least one measurable lesion.
✕Probably not a fit
Patients whose disease rapidly progresses or who cannot tolerate any dose of BI 3819026 may not experience a direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 trial enrolls adults with unresectable or metastatic solid tumors to find the highest BI 3819026 dose that can be tolerated when given alone and with ezabenlimab. Participants start with a low dose of BI 3819026, then move to higher doses in small groups if the previous dose is tolerated, while continuing on the same dose once assigned. Treatments may continue for up to about two years, with regular visits, safety assessments, blood tests, and imaging to monitor health and disease status. The study investigates safety and tolerability and collects data on how the drugs behave in the body.
Why it matters
Potential benefit: If successful, the study could identify a dose that balances safety with potential anti-cancer activity for patients receiving BI 3819026 alone or with ezabenlimab.
How similar studies have gone: Earlier phase studies of similar agents have shown dose-tolerability signals, but this exact combination is being explored in this study.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 : 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.
Where it's running
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Yale Cancer Center
New Haven, Connecticut, United States Recruiting -
Hackensack University Medical Center
Hackensack, New Jersey, United States Recruiting -
SCRI Oncology Partners
Nashville, Tennessee, United States Recruiting -
National Cancer Center Hospital East
Chiba, Kashiwa, Japan Recruiting -
National Cancer Center Hospital
Tokyo, Chuo-ku, Japan Recruiting -
Hospital Universitari Vall d'Hebron
Barcelona, Spain Recruiting
Show 3 more locations
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Clínica Universidad de Navarra
Pamplona, Spain Recruiting -
Hospital Clinico Universitario de Valencia
Valencia, Spain Recruiting -
New York University Langone Medical Center
New York, New York, United States Not yet recruiting
Study contacts
- Study coordinator: Boehringer Ingelheim
- Email: clintriage.rdg@boehringer-ingelheim.com
- Phone: 1-800-243-0127
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.