Advanced Solid CancerPhase 1NCT07607678
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 Phase 1 study testing BI 3819026 and Ezabenlimab (BI 754091) in people with Advanced Solid Cancer and Metastatic Solid Cancer, run by Boehringer Ingelheim at 9 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Cancer, Metastatic Solid Cancer
- What is being tested?
- BI 3819026 and Ezabenlimab (BI 754091)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 1 May 2026to 15 Oct 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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
- Has received prior therapy with an immune-checkpoint inhibitor that was discontinued due to immune-related adverse events (AE)
Show all 19Show fewer
- 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:
- 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
- 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:
- 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.
Trial locations and contacts
9 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 3 countries
United States4 sites, 4 recruiting
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 06511
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
New York University Langone Medical Center
New York, New York, 10016
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Clínica Universidad de Navarra
Pamplona, 31008
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Japan2 sites, 2 recruiting
- Recruiting
National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
About this study
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)
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.
- Conditions
- Advanced Solid Cancer, Metastatic Solid Cancer
- Being tested
- BI 3819026, Ezabenlimab (BI 754091)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 3819026Drug
BI 3819026
Ezabenlimab (BI 754091)Drug
Ezabenlimab (BI 754091)
| Study group | Role | What they receive |
|---|---|---|
| BI 3819026 + Ezabenlimab (BI 754091) dose group 1 | Experimental | Dose escalation Receives: Drug: BI 3819026; Drug: Ezabenlimab (BI 754091) |
| BI 3819026 + Ezabenlimab (BI 754091) dose group 2 | Experimental | Dose escalation Receives: Drug: BI 3819026; Drug: Ezabenlimab (BI 754091) |
| BI 3819026 + Ezabenlimab (BI 754091) dose group 3 | Experimental | Dose escalation Receives: Drug: BI 3819026; Drug: Ezabenlimab (BI 754091) |
| BI 3819026 + Ezabenlimab (BI 754091) dose group 4 | Experimental | Dose escalation Receives: Drug: BI 3819026; Drug: Ezabenlimab (BI 754091) |
| BI 3819026 + Ezabenlimab (BI 754091) dose group 5 | Experimental | Dose escalation Receives: Drug: BI 3819026; Drug: Ezabenlimab (BI 754091) |
| BI 3819026 + Ezabenlimab (BI 754091) dose group 3 backfill | Experimental | Not described Receives: Drug: BI 3819026; Drug: Ezabenlimab (BI 754091) |
| BI 3819026 + Ezabenlimab (BI 754091) dose group 4 backfill | Experimental | Not described Receives: Drug: BI 3819026; Drug: Ezabenlimab (BI 754091) |
| BI 3819026 + Ezabenlimab (BI 754091) dose group 5 backfill | Experimental | Not described Receives: Drug: BI 3819026; Drug: Ezabenlimab (BI 754091) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose-limiting toxicities (DLTs) in the primary DLT evaluation period
Measured: Up to 30 days
Secondary outcomes (12)
Occurrence of adverse events (AEs) with onset during the on-treatment period
Measured: Up to 2 years
Occurrence of DLTs with onset during the on-treatment period
Measured: Up to 2 years
Occurrence of AEs with onset during Cycle 1
Measured: Up to 15 days
Occurrence of DLTs with onset during Cycle 1
Measured: Up to 15 days
Maximum measured concentration of BI 3819026 alone (C max) in cycle 1
Measured: Up to 15 days
Maximum measured concentration of BI 3819026 alone (C max) in cycle 3
Measured: Up to Day 30
Maximum measured concentration of BI 3819026 + ezabenlimab combination (C max) in cycle 3
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline and up to 2 years
Treatment-induced changes in target cells ratio as compared with baseline
Backfill cohorts only
Measured: At baseline and up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 May 2026
- Primary completion5 Jun 2028 (estimated)
- Study completion15 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid CancerStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- dose escalation (Phase Ia)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607678
- Sponsor's protocol ID
- 2012-0001
- Other IDs
- 2025-522953-21-00, U1111-1328-0914, 2025
- Status last verified
- Sep 2026
- First submitted
- 18 May 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07607678
- Acronym / sponsor ID
- 2012-0001
- Conditions
- Advanced Solid Cancer, Metastatic Solid Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 May 2026 (actual)
- Primary completion
- 5 Jun 2028 (estimated)
- Study completion
- 15 Oct 2030 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- dose escalation (Phase Ia)
| Arm | Type | Receives |
|---|---|---|
| BI 3819026 + Ezabenlimab (BI 754091) dose group 1 | Experimental | Drug: BI 3819026, Drug: Ezabenlimab (BI 754091)Dose escalation |
| BI 3819026 + Ezabenlimab (BI 754091) dose group 2 | Experimental | Drug: BI 3819026, Drug: Ezabenlimab (BI 754091)Dose escalation |
| BI 3819026 + Ezabenlimab (BI 754091) dose group 3 | Experimental | Drug: BI 3819026, Drug: Ezabenlimab (BI 754091)Dose escalation |
| BI 3819026 + Ezabenlimab (BI 754091) dose group 4 | Experimental | Drug: BI 3819026, Drug: Ezabenlimab (BI 754091)Dose escalation |
| BI 3819026 + Ezabenlimab (BI 754091) dose group 5 | Experimental | Drug: BI 3819026, Drug: Ezabenlimab (BI 754091)Dose escalation |
| BI 3819026 + Ezabenlimab (BI 754091) dose group 3 backfill | Experimental | Drug: BI 3819026, Drug: Ezabenlimab (BI 754091) |
| BI 3819026 + Ezabenlimab (BI 754091) dose group 4 backfill | Experimental | Drug: BI 3819026, Drug: Ezabenlimab (BI 754091) |
| BI 3819026 + Ezabenlimab (BI 754091) dose group 5 backfill | Experimental | Drug: BI 3819026, Drug: Ezabenlimab (BI 754091) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 3819026BI 3819026 | Drug | BI 3819026 + Ezabenlimab (BI 754091) dose group 1, BI 3819026 + Ezabenlimab (BI 754091) dose group 2, BI 3819026 + Ezabenlimab (BI 754091) dose group 3, BI 3819026 + Ezabenlimab (BI 754091) dose group 3 backfill, BI 3819026 + Ezabenlimab (BI 754091) dose group 4, BI 3819026 + Ezabenlimab (BI 754091) dose group 4 backfill, BI 3819026 + Ezabenlimab (BI 754091) dose group 5, BI 3819026 + Ezabenlimab (BI 754091) dose group 5 backfill |
| Ezabenlimab (BI 754091)Ezabenlimab (BI 754091) | Drug | BI 3819026 + Ezabenlimab (BI 754091) dose group 1, BI 3819026 + Ezabenlimab (BI 754091) dose group 2, BI 3819026 + Ezabenlimab (BI 754091) dose group 3, BI 3819026 + Ezabenlimab (BI 754091) dose group 3 backfill, BI 3819026 + Ezabenlimab (BI 754091) dose group 4, BI 3819026 + Ezabenlimab (BI 754091) dose group 4 backfill, BI 3819026 + Ezabenlimab (BI 754091) dose group 5, BI 3819026 + Ezabenlimab (BI 754091) dose group 5 backfill |
Primary outcome
Occurrence of dose-limiting toxicities (DLTs) in the primary DLT evaluation period
Time frame: Up to 30 days
12 secondary outcomes
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
Time frame: At baseline and up to 2 years
Treatment-induced changes in target cells ratio as compared with baseline
Time frame: At baseline and up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 3819026 and Ezabenlimab (BI 754091) in people with Advanced Solid Cancer and Metastatic Solid Cancer, run by Boehringer Ingelheim at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Spain, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of dose-limiting toxicities (DLTs) in the primary DLT evaluation period (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.