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
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.
Patients with brain metastases are eligible provided they meet the following criteria:
Exclusion Criteria :
Previous or concomitant malignancies other than the one treated in this trial within the last 3 years except:
Radiotherapy within 4 weeks prior to start of the trial treatment except as follows:
Patients with history of HIV infection who meet one or more of the following criteria:
Dose escalation
Drug: BI 3819026 · Drug: Ezabenlimab (BI 754091)
Dose escalation
Drug: BI 3819026 · Drug: Ezabenlimab (BI 754091)
Dose escalation
Drug: BI 3819026 · Drug: Ezabenlimab (BI 754091)
Dose escalation
Drug: BI 3819026 · Drug: Ezabenlimab (BI 754091)
Dose escalation
Drug: BI 3819026 · Drug: Ezabenlimab (BI 754091)
Drug: BI 3819026 · Drug: Ezabenlimab (BI 754091)
Drug: BI 3819026 · Drug: Ezabenlimab (BI 754091)
Drug: BI 3819026 · Drug: Ezabenlimab (BI 754091)
BI 3819026
Ezabenlimab (BI 754091)
Occurrence of dose-limiting toxicities (DLTs) in the primary DLT evaluation period
Time frame: Up to 30 days
Occurrence of adverse events (AEs) with onset during the on-treatment period
Time frame: Up to 2 years
Occurrence of DLTs with onset during the on-treatment period
Time frame: Up to 2 years
Occurrence of AEs with onset during Cycle 1
Time frame: Up to 15 days
Occurrence of DLTs with onset during Cycle 1
Time frame: Up to 15 days
Maximum measured concentration of BI 3819026 alone (C max) in cycle 1
Time frame: Up to 15 days
Maximum measured concentration of BI 3819026 alone (C max) in cycle 3
Time frame: Up to Day 30
Maximum measured concentration of BI 3819026 + ezabenlimab combination (C max) in cycle 3
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At baseline and up to 2 years
Treatment-induced changes in target cells ratio as compared with baseline
Backfill cohorts only
Time frame: At baseline and up to 2 years
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
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Boehringer Ingelheim