Solid TumorsPhase 1NCT07395258
A Study to Test Different Doses of BI 3923948 Alone and in Combination With an Anti-PD-1 Antibody in People With Different Types of Advanced Cancer (Solid Tumors)
A Phase 1 study testing BI 3923948 and Ezabenlimab in people with Solid Tumors, run by Boehringer Ingelheim at 2 sites in United States.
Trial summary
This study is open to adults aged 18 and over or above legal age with different types of recurrent advanced cancer (solid tumors) that have spread to other parts of the body and that are accessible for injection and biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- BI 3923948 and Ezabenlimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Apr 2026to 12 Feb 2032
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Measurable disease as defined per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Patient has 1 or more accessible lesions (2 or more preferred)
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Life expectancy of at least ≥3 months after the start of the treatment according to the investigator's judgement Further inclusion criteria apply.
Who cannot join
- Patients with known primary brain tumors, leptomeningeal disease or untreated brain metastases. Subjects with previously treated brain metastases may participate provided the brain metastases are stable
- Previous treatment with vesicular stomatitis virus (VSV)-based agents
- Concomitant medication or condition considered a high risk for complications from injection
- History of common terminology criteria for adverse events (CTCAE) v5 grade 3 or higher severe hypersensitivity reactions to previous anti-programmed cell death 1 (anti-PD-1)/anti-programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) (Arm B only) Further exclusion criteria apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Minnesota
Minneapolis, Minnesota, 55455
Yale New Haven Hospital
New Haven, Connecticut, 06511
About this study
Official title: Phase I Open-label Dose Escalation Trial of BI 3923948 Monotherapy and in Combination With an Anti-PD-1 mAb in Patients With Advanced, Unresectable and/or Metastatic Solid Tumors
This study is open to adults aged 18 and over or above legal age with different types of recurrent advanced cancer (solid tumors) that have spread to other parts of the body and that are accessible for injection and biopsy. This is a study for people for whom previous treatment was not successful or no treatment exists, with a life expectancy of at least 3 months after starting study treatment. The purpose of this study is to find the highest dose of a medicine called BI 3923948, that people with advanced cancer can tolerate, when taken alone and together with a type of antibody called a checkpoint inhibitor (anti-programmed cell death protein 1 antibody). Another purpose is to check whether the study treatment can fight cancer. In this study, BI 3923948 is given to people for the first time.
This study has 2 arms. In Arm A, participants get BI 3923948 alone for up to 3 months. In Arm B, participants get BI 3923948 in combination with a checkpoint inhibitor. Participants who take the combination treatment get BI 3923948 for up to 3 months and a checkpoint inhibitor for up to 1 year. BI 3923948 is given as injection(s) into the tumor, and the checkpoint inhibitor is given as an infusion into a vein. Participants get the medicines about every 3 weeks. This is called a treatment cycle. Only in treatment cycle 1 will participants get BI 3923948 twice in the first week.
Participants visit the site study site regularly. The number of study visits vary based on the study arm and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors closely check the health of the participants and also take note of any health problems that could have been caused by the study treatment.
- Conditions
- Solid Tumors
- Being tested
- BI 3923948, Ezabenlimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 3923948Drug
BI 3923948
EzabenlimabDrug
Ezabenlimab
| Study group | Role | What they receive |
|---|---|---|
| Arm A: BI 3923948 monotherapy | Experimental | Not described Receives: Drug: BI 3923948 |
| Arm B: BI 3923948 in combination with ezabenlimab | Experimental | Not described Receives: Drug: BI 3923948; 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
Measured: up to 3 weeks
Secondary outcomes (2)
Occurrence of DLTs during the on-treatment period
Measured: up to 12 months
Occurrence of Adverse Events (AEs) during the on-treatment period
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start2 Apr 2026
- Primary completion5 Jun 2031 (estimated)
- Study completion12 Feb 2032 (estimated)
Why it stopped: Temporary enrolment hold as a precautionary measure following a safety event in a related trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- 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
- NCT07395258
- Sponsor's protocol ID
- 1538-0001
- Other IDs
- U1111-1319-8046, 2025-521438-27-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 2 Feb 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Open-label Dose Escalation Trial of BI 3923948 Monotherapy and in Combination With an Anti-PD-1 mAb in Patients With Advanced, Unresectable and/or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07395258
- Acronym / sponsor ID
- 1538-0001
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Temporary enrolment hold as a precautionary measure following a safety event in a related trial
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- 5 Jun 2031 (estimated)
- Study completion
- 12 Feb 2032 (estimated)
- First posted
- 9 Feb 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 aged 18 and over or above legal age with different types of recurrent advanced cancer (solid tumors) that have spread to other parts of the body and that are accessible for injection and biopsy. This is a study for people for whom previous treatment was not successful or no treatment exists, with a life expectancy of at least 3 months after starting study treatment. The purpose of this study is to find the highest dose of a medicine called BI 3923948, that people with advanced cancer can tolerate, when taken alone and together with a type of antibody called a checkpoint inhibitor (anti-programmed cell death protein 1 antibody). Another purpose is to check whether the study treatment can fight cancer. In this study, BI 3923948 is given to people for the first time.
This study has 2 arms. In Arm A, participants get BI 3923948 alone for up to 3 months. In Arm B, participants get BI 3923948 in combination with a checkpoint inhibitor. Participants who take the combination treatment get BI 3923948 for up to 3 months and a checkpoint inhibitor for up to 1 year. BI 3923948 is given as injection(s) into the tumor, and the checkpoint inhibitor is given as an infusion into a vein. Participants get the medicines about every 3 weeks. This is called a treatment cycle. Only in treatment cycle 1 will participants get BI 3923948 twice in the first week.
Participants visit the site study site regularly. The number of study visits vary based on the study arm and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors closely check the health of the participants and also take note of any health problems that could have been caused by the study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: BI 3923948 monotherapy | Experimental | Drug: BI 3923948 |
| Arm B: BI 3923948 in combination with ezabenlimab | Experimental | Drug: BI 3923948, Drug: Ezabenlimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Measurable disease as defined per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Patient has 1 or more accessible lesions (2 or more preferred)
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Life expectancy of at least ≥3 months after the start of the treatment according to the investigator's judgement Further inclusion criteria apply.
Key exclusion criteria (4 listed)
- Patients with known primary brain tumors, leptomeningeal disease or untreated brain metastases. Subjects with previously treated brain metastases may participate provided the brain metastases are stable
- Previous treatment with vesicular stomatitis virus (VSV)-based agents
- Concomitant medication or condition considered a high risk for complications from injection
- History of common terminology criteria for adverse events (CTCAE) v5 grade 3 or higher severe hypersensitivity reactions to previous anti-programmed cell death 1 (anti-PD-1)/anti-programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) (Arm B only) Further exclusion criteria apply.
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 3923948BI 3923948 | Drug | Arm A: BI 3923948 monotherapy, Arm B: BI 3923948 in combination with ezabenlimab |
| EzabenlimabEzabenlimab | Drug | Arm B: BI 3923948 in combination with ezabenlimab |
Primary outcome
Occurrence of Dose-limiting toxicities (DLTs) during the primary DLT evaluation period
Time frame: up to 3 weeks
2 secondary outcomes
Occurrence of DLTs during the on-treatment period
Time frame: up to 12 months
Occurrence of Adverse Events (AEs) during the on-treatment period
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 3923948 and Ezabenlimab in people with Solid Tumors, run by Boehringer Ingelheim at 2 sites in United States.
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 4 inclusion and 4 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: paused, as of the sponsor's last update on 13 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 2 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 (time frame: up to 3 weeks). 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 13 Oct 2026; AzTrials last refreshed its copy on 2 Nov 2026.