Advanced Solid TumourPhase 1NCT07851103
A Study to Test Different Doses of BI 3968621 When Given Alone or With Ezabenlimab in Patients With Advanced Cancer
A Phase 1 study testing BI 3968621 and ezabenlimab in people with Advanced Solid Tumour, run by Boehringer Ingelheim at 10 sites in 5 countries.
Trial summary
This study is open to adults with advanced cancer that cannot be removed by surgery or have spread to other parts of the body. The purpose of this study is to find the highest and most suitable dose of BI 3968621 that people with advanced cancer can tolerate when taken alone or with ezabenlimab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumour
- What is being tested?
- BI 3968621 and ezabenlimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 26 Oct 2026to 3 Sep 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
- Male and female participants ≥18 years of age and at least at the legal age of consent
- Patients with a histologically confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type). Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not eligible for established treatment options. Patients must have exhausted approved treatment options known to prolong survival for their disease
- At least one measurable lesion outside of central nervous system (CNS) as defined per modified Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy ≥3 months at the start of treatment in the opinion of the investigator
- Patients with known brain metastases are eligible, provided they meet the protocol-defined criteria
- Patients must have adequate organ function based on haematological, hepatic, renal, and coagulation parameters Further inclusion criteria apply.
Who cannot join
- Previous or concomitant malignancies other than the one treated in this trial within the past 3 years (except effectively treated malignancy considered cured by local treatment, e.g. non melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ)
- Patient with known leptomeningeal disease or spinal cord compression due to disease
- Patients with hepatitis C infection or active hepatitis B infection (chronic or acute)
- Patients with known history of Human immunodeficiency virus (HIV) infection who meet protocol-defined criteria
- Patient with active autoimmune disease or a documented history of autoimmune disease, which requires systemic treatment (e.g. corticosteroids or immunosuppressive drugs)
- Patient with a diagnosis of immunodeficiency other than HIV
- Manifestation of malabsorption or any other condition that could affect oral absorption, distribution or metabolism of the study drug Further exclusion criteria apply.
Trial locations and contacts
10 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 5 countries
United States5 sites, 5 recruiting
- Not yet recruiting
Emory University
Atlanta, Georgia, 30322
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Sarah Cannon Research Institute-Nashville-48456
Nashville, Tennessee, 37203
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Florida Cancer Specialists-Sarasota-61670
Sarasota, Florida, 34232
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Spain2 sites, 2 recruiting
- Not yet recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital Clinico De Valencia (INCLIVA)
Valencia, 46010
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Belgium1 site, 1 recruiting
- Not yet recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
France1 site, 1 recruiting
- Not yet recruiting
Institut Gustave Roussy
Villejuif, 94800
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Japan1 site, 1 recruiting
- Not yet recruiting
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
About this study
Official title: A First-in-human, Multicentre, Phase Ia Dose Escalation Study of BI 3968621 as Monotherapy and in Combination With Ezabenlimab to Investigate Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumour Activity in Patients With Advanced Solid Tumours
This study is open to adults with advanced cancer that cannot be removed by surgery or have spread to other parts of the body. The purpose of this study is to find the highest and most suitable dose of BI 3968621 that people with advanced cancer can tolerate when taken alone or with ezabenlimab. Another purpose is to find out if taking these medicines can stop tumours from growing or make tumours shrink. In this study, BI 3968621 is given to people for the first time.
The study is done in 3 parts. The parts are called Part A, Part A2, and Part B. Participants get BI 3968621 alone or in combination with ezabenlimab depending on which part they are in. Part A is done to find the highest and the most suitable dose of BI 3968621 that people with advanced cancer can tolerate. Part A2 is done to find out if taking BI 3968621, at certain dose levels, can stop or slow down tumour growth in participants with kidney cancer. Part B is done to find out how BI 3968621 is tolerated when given with ezabenlimab. BI 3968621 is taken daily as tablets. Ezabenlimab is given as an infusion into a vein once every 3 weeks.
Participants can receive study treatment for up to 2 years if they benefit and can tolerate it. During this time, they visit the study site regularly. The number of visits depends on how participants respond to and tolerate the study treatment. Researchers look at the number of participants with certain severe health problems that happen within 3 weeks after the first study treatment. The study doctors check participants' health, take note of unwanted effects, take blood samples, and check how the cancer responds to study treatment.
- Conditions
- Advanced Solid Tumour
- Being tested
- BI 3968621, ezabenlimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 3968621Drug
BI 3968621
ezabenlimabDrug
ezabenlimab
| Study group | Role | What they receive |
|---|---|---|
| BI 3968621 dose escalation monotherapy (Part A) | Experimental | Not described Receives: Drug: BI 3968621 |
| BI 3968621 dose expansion monotherapy (Part A2) | Experimental | Not described Receives: Drug: BI 3968621 |
| BI 3968621 + ezabenlimab dose escalation combination therapy (Part B) | Experimental | Not described Receives: Drug: BI 3968621; Drug: ezabenlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose-limiting toxicities (DLTs) during the primary DLT evaluation period (Dose escalation part A and B)
Measured: During the first treatment cycle, up to 21 days
Objective response (OR)
defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), where BOR is determined by investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 from first administration until earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anticancer therapy, lost to follow-up, or withdrawal of consent, whichever occurs first (Part A2)
Measured: Up to 2 years
Secondary outcomes (16)
Occurrence of treatment-emergent adverse events (AEs)
Measured: Up to 2 years
Occurrence of dose-limiting toxicities (DLTs)
Measured: Up to 2 years
Occurrence of drug-related AEs
Measured: Up to 2 years
Occurrence of treatment-emergent serious adverse events (SAEs)
Measured: Up to 2 years
Objective response (OR)
defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), where BOR is determined by investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 from first administration until earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anticancer therapy, lost to follow-up, or withdrawal of consent, whichever occurs first (part A + B)
Measured: Up to 2 years
Duration of response (DoR)
based on RECIST v1.1, defined as the time from first confirmed CR or PR until the earliest of progressive disease (PD) or death among patients with an OR (part A2)
Measured: Up to 2 years
Progression-free survival (PFS)
defined as the time from first treatment administration until tumour progression according to RECIST v1.1 or death from any cause, whichever occurs first (part A2)
Measured: Up to 2 years
Progression-free survival (PFS) at 6 months (PFS6)
defined as being alive and without tumour progression at 6 months from first treatment administration (part A2)
Measured: At 6 months
Clinical Benefit (CB)
defined as achievement of BOR of CR or PR of any duration, or stable disease (SD) of at least 6 months according to RECIST v1.1 (part A2)
Measured: Up to 2 years
Disease control (DC)
based on RECIST v1.1, defined as the best overall response of CR, PR, or SD from the first administration of trial medication until the earliest of PD, death, last evaluable tumour assessment before the start of subsequent anticancer therapy, loss to follow-up, or withdrawal of consent, whichever occurs first
Measured: Up to 2 years
Immune objective response (iOR)
as determined by investigator's assessment according to iRECIST, defined as immune BOR (iBOR) of immune CR (iCR) or immune PR (iPR), determined from date of first administration until earliest of disease progression (immune unconfirmed progressive disease [iUPD] that is confirmed at next radiological assessment), death, last evaluable tumour assessment before start subsequent anticancer therapy, loss to follow-up, or withdrawal of consent, whichever occurs first
Measured: Up to 2 years
Immune DC (iDC)
based on iRECIST v1.1, defined as the best overall response of iCR, iPR or iSD from the first administration of trial medication until the earliest of iUPD (provided that iCPD is the next time point response, i.e. progression is confirmed at the next tumour assessment), death, last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow-up, or withdrawal of consent, whichever occurs first
Measured: Up to 2 years
Maximum measured concentration of the analyte in plasma (after the first dose in Cycle 1) (Cmax)
Measured: Up to Day 15 in cycle 1 (each cycle is 21 days)
Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose in Cycle 1 (AUCτ,1)
Measured: Up to Day 15 in cycle 1 (each cycle is 21 days)
Maximum measured concentration of the analyte in plasma at steady state (after the first dose in Cycle 2) (Cmax,ss)
Measured: Up to Day 15 in cycle 2 (each cycle is 21 days)
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (after the first dose in Cycle 2) (AUCτ,ss)
Measured: Up to Day 15 in cycle 2 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start26 Oct 2026 (estimated)
- Primary completion3 Sep 2030 (estimated)
- Study completion3 Sep 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 TumourStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 90 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
- NCT07851103
- Sponsor's protocol ID
- 2010-0001
- Other IDs
- 2026-526199-22-00, U1111-1337-3740
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 28 Oct 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Multicentre, Phase Ia Dose Escalation Study of BI 3968621 as Monotherapy and in Combination With Ezabenlimab to Investigate Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumour Activity in Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT07851103
- Acronym / sponsor ID
- 2010-0001
- Conditions
- Advanced Solid Tumour
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- 3 Sep 2030 (estimated)
- Study completion
- 3 Sep 2030 (estimated)
- First posted
- 1 Oct 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 that cannot be removed by surgery or have spread to other parts of the body. The purpose of this study is to find the highest and most suitable dose of BI 3968621 that people with advanced cancer can tolerate when taken alone or with ezabenlimab. Another purpose is to find out if taking these medicines can stop tumours from growing or make tumours shrink. In this study, BI 3968621 is given to people for the first time.
The study is done in 3 parts. The parts are called Part A, Part A2, and Part B. Participants get BI 3968621 alone or in combination with ezabenlimab depending on which part they are in. Part A is done to find the highest and the most suitable dose of BI 3968621 that people with advanced cancer can tolerate. Part A2 is done to find out if taking BI 3968621, at certain dose levels, can stop or slow down tumour growth in participants with kidney cancer. Part B is done to find out how BI 3968621 is tolerated when given with ezabenlimab. BI 3968621 is taken daily as tablets. Ezabenlimab is given as an infusion into a vein once every 3 weeks.
Participants can receive study treatment for up to 2 years if they benefit and can tolerate it. During this time, they visit the study site regularly. The number of visits depends on how participants respond to and tolerate the study treatment. Researchers look at the number of participants with certain severe health problems that happen within 3 weeks after the first study treatment. The study doctors check participants' health, take note of unwanted effects, take blood samples, and check how the cancer responds to study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BI 3968621 dose escalation monotherapy (Part A) | Experimental | Drug: BI 3968621 |
| BI 3968621 dose expansion monotherapy (Part A2) | Experimental | Drug: BI 3968621 |
| BI 3968621 + ezabenlimab dose escalation combination therapy (Part B) | Experimental | Drug: BI 3968621, Drug: ezabenlimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female participants ≥18 years of age and at least at the legal age of consent
- Patients with a histologically confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type). Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not eligible for established treatment options. Patients must have exhausted approved treatment options known to prolong survival for their disease
- At least one measurable lesion outside of central nervous system (CNS) as defined per modified Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy ≥3 months at the start of treatment in the opinion of the investigator
Key exclusion criteria (7 listed)
- Previous or concomitant malignancies other than the one treated in this trial within the past 3 years (except effectively treated malignancy considered cured by local treatment, e.g. non melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ)
- Patient with known leptomeningeal disease or spinal cord compression due to disease
- Patients with hepatitis C infection or active hepatitis B infection (chronic or acute)
- Patients with known history of Human immunodeficiency virus (HIV) infection who meet protocol-defined criteria
- Patient with active autoimmune disease or a documented history of autoimmune disease, which requires systemic treatment (e.g. corticosteroids or immunosuppressive drugs)
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 3968621BI 3968621 | Drug | BI 3968621 + ezabenlimab dose escalation combination therapy (Part B), BI 3968621 dose escalation monotherapy (Part A), BI 3968621 dose expansion monotherapy (Part A2) |
| ezabenlimabezabenlimab | Drug | BI 3968621 + ezabenlimab dose escalation combination therapy (Part B) |
Primary outcome
Occurrence of dose-limiting toxicities (DLTs) during the primary DLT evaluation period (Dose escalation part A and B)
Time frame: During the first treatment cycle, up to 21 days
Objective response (OR)
Time frame: Up to 2 years
defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), where BOR is determined by investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 from first administration until earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anticancer therapy, lost to follow-up, or withdrawal of consent, whichever occurs first (Part A2)
16 secondary outcomes
Occurrence of treatment-emergent adverse events (AEs)
Time frame: Up to 2 years
Occurrence of dose-limiting toxicities (DLTs)
Time frame: Up to 2 years
Occurrence of drug-related AEs
Time frame: Up to 2 years
Occurrence of treatment-emergent serious adverse events (SAEs)
Time frame: Up to 2 years
Objective response (OR)
Time frame: Up to 2 years
Duration of response (DoR)
Time frame: Up to 2 years
Progression-free survival (PFS)
Time frame: Up to 2 years
Progression-free survival (PFS) at 6 months (PFS6)
Time frame: At 6 months
Clinical Benefit (CB)
Time frame: Up to 2 years
Disease control (DC)
Time frame: Up to 2 years
Immune objective response (iOR)
Time frame: Up to 2 years
Immune DC (iDC)
Time frame: Up to 2 years
Maximum measured concentration of the analyte in plasma (after the first dose in Cycle 1) (Cmax)
Time frame: Up to Day 15 in cycle 1 (each cycle is 21 days)
Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose in Cycle 1 (AUCτ,1)
Time frame: Up to Day 15 in cycle 1 (each cycle is 21 days)
Maximum measured concentration of the analyte in plasma at steady state (after the first dose in Cycle 2) (Cmax,ss)
Time frame: Up to Day 15 in cycle 2 (each cycle is 21 days)
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (after the first dose in Cycle 2) (AUCτ,ss)
Time frame: Up to Day 15 in cycle 2 (each cycle is 21 days)
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 28 Oct 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.
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 3968621 and ezabenlimab in people with Advanced Solid Tumour, run by Boehringer Ingelheim at 10 sites in 5 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 7 inclusion and 7 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Spain, Belgium, France, 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 (018002430127, 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) during the primary DLT evaluation period (Dose escalation part A and B) (time frame: During the first treatment cycle, up to 21 days). The study lists 2 primary outcomes in all. 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 28 Oct 2026.