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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522953-21-00 | Registry Identifier | CTIS | |
| U1111-1328-0914 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 3819026 + Ezabenlimab (BI 754091) dose group 1 | Experimental | Dose escalation |
|
| BI 3819026 + Ezabenlimab (BI 754091) dose group 2 | Experimental | Dose escalation |
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| BI 3819026 + Ezabenlimab (BI 754091) dose group 3 | Experimental | Dose escalation |
|
| BI 3819026 + Ezabenlimab (BI 754091) dose group 4 | Experimental | Dose escalation |
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| BI 3819026 + Ezabenlimab (BI 754091) dose group 5 | Experimental | Dose escalation |
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| BI 3819026 + Ezabenlimab (BI 754091) dose group 3 backfill |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 3819026 | Drug | BI 3819026 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of dose-limiting toxicities (DLTs) in the primary DLT evaluation period | Up to 30 days |
| 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 | |
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Inclusion Criteria :
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.
At least one measurable disease lesion outside of the central nervous system (CNS) defined per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
Patients with brain metastases are eligible provided they meet the following criteria:
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
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)
Adequate liver, bone marrow and renal organ function Further inclusion criteria apply.
Exclusion Criteria :
Previous or concomitant malignancies other than the one treated in this trial within the last 3 years except:
Has received prior therapy with an immune-checkpoint inhibitor that was discontinued due to immune-related adverse events (AE)
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
Radiotherapy within 4 weeks prior to start of the trial treatment except as follows:
Active/previous history of interstitial lung disease, pulmonary fibrosis, organising pneumonia or non-infectious pneumonitis (any grade)
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
Patient has a diagnosis of immunodeficiency other than human immunodeficiency virus (HIV)
Patients with history of HIV infection who meet one or more of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim | Contact | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Cancer Center | Not yet recruiting | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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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.
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.
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.
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dose escalation (Phase Ia)
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| BI 3819026 + Ezabenlimab (BI 754091) dose group 4 backfill | Experimental |
|
| BI 3819026 + Ezabenlimab (BI 754091) dose group 5 backfill | Experimental |
|
| Ezabenlimab (BI 754091) | Drug | Ezabenlimab (BI 754091) |
|
| 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 |
| Hackensack University Medical Center | Not yet recruiting | Hackensack | New Jersey | 07601 | United States |
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| New York University Langone Medical Center | Not yet recruiting | New York | New York | 10016 | United States |
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| SCRI Oncology Partners | Not yet recruiting | Nashville | Tennessee | 37203 | United States |
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| National Cancer Center Hospital East | Not yet recruiting | Chiba, Kashiwa | 277-8577 | Japan |
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| National Cancer Center Hospital | Recruiting | Tokyo, Chuo-ku | 104-0045 | Japan |
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| Hospital Universitari Vall d'Hebron | Not yet recruiting | Barcelona | 08035 | Spain |
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| ClĂnica Universidad de Navarra | Not yet recruiting | Pamplona | 31008 | Spain |
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| Hospital Clinico Universitario de Valencia | Recruiting | Valencia | 46010 | Spain |
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