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 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)

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.

Study Overview

• Status: Recruiting
• Conditions: Unresectable Advanced or Metastatic Solid Cancer
• Intervention / Treatment: Drug: BI 3819026; Drug: Ezabenlimab (BI 754091)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Boehringer Ingelheim; Phone Number: 1-800-243-0127; Email: clintriage.rdg@boehringer-ingelheim.com

Study Locations

• Japan
  • Chiba, Kashiwa, Japan, 277-8577
    • Not yet recruiting
    • National Cancer Center Hospital East
    • Contact: Boehringer Ingelheim; Phone Number: 05050508862; Email: nippon@bitrialsupport.com
  • Tokyo, Chuo-ku, Japan, 104-0045
    • Not yet recruiting
    • National Cancer Center Hospital
    • Contact: Boehringer Ingelheim; Phone Number: 05050508862; Email: nippon@bitrialsupport.com
• Spain
  • Barcelona, Spain, 08035
    • Not yet recruiting
    • Hospital Universitari Vall d'Hebron
    • Contact: Boehringer Ingelheim; Phone Number: 900876092; Email: espana@bitrialsupport.com
  • Pamplona, Spain, 31008
    • Not yet recruiting
    • Clínica Universidad de Navarra
    • Contact: Boehringer Ingelheim; Phone Number: 900876092; Email: espana@bitrialsupport.com
  • Valencia, Spain, 46010
    • Recruiting
    • Hospital Clinico Universitario de Valencia
    • Contact: Boehringer Ingelheim; Phone Number: 900876092; Email: espana@bitrialsupport.com
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Not yet recruiting
      • Yale Cancer Center
      • Contact: Boehringer Ingelheim; Phone Number: 833-602-2368; Email: unitedstates@bitrialsupport.com
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Not yet recruiting
      • Hackensack University Medical Center
      • Contact: Boehringer Ingelheim; Phone Number: 833-602-2368; Email: unitedstates@bitrialsupport.com
  • New York
    • New York, New York, United States, 10016
      • Not yet recruiting
      • New York University Langone Medical Center
      • Contact: Boehringer Ingelheim; Phone Number: 833-602-2368; Email: unitedstates@bitrialsupport.com
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Not yet recruiting
      • SCRI Oncology Partners
      • Contact: Boehringer Ingelheim; Phone Number: 833-602-2368; Email: unitedstates@bitrialsupport.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 1; Dose escalation	Drug: BI 3819026; BI 3819026; Drug: Ezabenlimab (BI 754091); Ezabenlimab (BI 754091)
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 2; Dose escalation	Drug: BI 3819026; BI 3819026; Drug: Ezabenlimab (BI 754091); Ezabenlimab (BI 754091)
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 3; Dose escalation	Drug: BI 3819026; BI 3819026; Drug: Ezabenlimab (BI 754091); Ezabenlimab (BI 754091)
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 4; Dose escalation	Drug: BI 3819026; BI 3819026; Drug: Ezabenlimab (BI 754091); Ezabenlimab (BI 754091)
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 5; Dose escalation	Drug: BI 3819026; BI 3819026; Drug: Ezabenlimab (BI 754091); Ezabenlimab (BI 754091)
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 3 backfill	Drug: BI 3819026; BI 3819026; Drug: Ezabenlimab (BI 754091); Ezabenlimab (BI 754091)
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 4 backfill	Drug: BI 3819026; BI 3819026; Drug: Ezabenlimab (BI 754091); Ezabenlimab (BI 754091)
Experimental: BI 3819026 + Ezabenlimab (BI 754091) dose group 5 backfill	Drug: BI 3819026; BI 3819026; Drug: Ezabenlimab (BI 754091); Ezabenlimab (BI 754091)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of dose-limiting toxicities (DLTs) in the primary DLT evaluation period	Up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of adverse events (AEs) with onset during the on-treatment period		Up to 2 years
Occurrence of DLTs with onset during the on-treatment period		Up to 2 years
Occurrence of AEs with onset during Cycle 1		Up to 15 days
Occurrence of DLTs with onset during Cycle 1		Up to 15 days
Maximum measured concentration of BI 3819026 alone (C max) in cycle 1		Up to 15 days
Maximum measured concentration of BI 3819026 alone (C max) in cycle 3		Up to Day 30
Maximum measured concentration of BI 3819026 + ezabenlimab combination (C max) in cycle 3		Up to Day 30
Area under concentration-time curve of BI 3819026 alone over a uniform dosing interval 0 - 504 h (AUC 0-504) in cycle 1		Up to 15 days
Area under concentration-time curve of BI 3819026 alone over a uniform dosing interval 0 - 504 h (AUC 0-504) in cycle 3		Up to Day 30
Area under concentration-time curve of BI 3819026 + ezabenlimab combination over a uniform dosing interval 0 - 504 h (AUC 0-504) in cycle 3		Up to Day 30
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	At baseline and up to 2 years
Treatment-induced changes in target cells ratio as compared with baseline	Backfill cohorts only	At baseline and up to 2 years

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2026
• Primary Completion (Estimated): June 5, 2028
• Study Completion (Estimated): October 15, 2030

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2012-0001; 2025-522953-21-00 (Registry Identifier: CTIS); U1111-1328-0914 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• IPD Sharing Access Criteria: For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No