Solid TumorsPhase 1NCT05471856
A Study to Test How Different Doses of BI 1703880 in Combination With Ezabenlimab Are Tolerated in People With Different Types of Advanced Cancer (Solid Tumours)
A Phase 1 study testing BI 1703880 and Ezabenlimab in people with Solid Tumors, run by Boehringer Ingelheim at 21 sites in 6 countries.
Trial summary
This study is open to adults with different types of advanced cancer. People can take part if previous treatment was not successful, or no treatment exists. The purpose of this study is to find the highest dose of a medicine called BI 1703880 that people with advanced cancer can tolerate when taken together with… 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 1703880 and Ezabenlimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 21 sitesin 6 countries
- Study dates
- 24 Feb 2023to 2 Jan 2029
- 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
- Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic or relapsed/refractory solid tumour. Patient must have at least one measurable lesion (according to Response Criteria in Solid Tumours (RECIST 1.1)).
- Patient must have exhausted or refused established treatment options for the malignant disease, or is not eligible for established treatment options.
- Has a lesion amenable to pre-treatment and on-treatment biopsy and patient consents to both biopsies.
- Medically fit and willing to undergo all mandatory trial procedures.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Adequate organ function or bone marrow reserve as demonstrated at screening by the following laboratory values:
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- Absolute neutrophil count ≥ 1.5x10^9/L (≥ 1.5x10^3/μL, ≥ 1500/mm3); platelet count ≥ 100x10^9/L (≥ 100x10^3/μL, ≥ 100x10^3/mm3), without the use of hematopoietic growth factors within 4 weeks of start of trial medication
- Haemoglobin ≥ 90 g/L (≥ 9.0 g/dL, ≥ 5.6 mmol/L)
- Estimated glomerular filtration rate (eGFR) ≥60 ml/min/1.73m^2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula)
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN if transaminase elevation is attributable to liver metastases.
- Total bilirubin ≤ 1.5 x ULN, except for patients with Gilbert's syndrome: total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN
- partial thromboplastin time (PTT) / activated partial thromboplastin time (aPTT) <1.5 x ULN
- Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the informed consent form (ICF).
- Signed and dated written ICF in accordance with International Council for Harmonisation- Good Clinical Practice (ICH-GCP) and local legislation, obtained before performing any protocol related procedures that are not part of normal standard of practice care. Note: If a patient declines to participate in the voluntary biobanking component of the trial, he/she will not be excluded from other aspects of the trial.
- Further inclusion criteria apply
Who cannot join
- Any investigational or antitumour treatment within 4 weeks or 5 half-life periods prior to the first treatment whichever is shorter.
- Prior STING agonist therapy.
- Prior intolerability of a anti-programmed cell death protein 1 (PD-1) or anti-programmed cell death ligand 1 (PD-L1) therapy.
- History of allergy or hypersensitivity to study agent components.
- Immunosuppressive therapies including, but not limited to, systemic corticosteroids at doses exceeding >10 mg/day of prednisone or equivalent, and tumour necrosis factor-alpha blockers.
- Persistent toxicity from previous treatments (including immune related Adverse Events (irAEs)) that has not resolved to Grade ≤1, except for alopecia, xerostomia, and immunotherapy related endocrinopathies.
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- Evidence of active, non-treatment related autoimmune disease, except for endocrinopathies.
- History or complication of pneumonitis or interstitial lung disease within the last 12 months, or any prior pneumonitis related to immunotherapy.
- Further exclusion criteria apply
Trial locations and contacts
21 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 6 countries
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Not yet recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
CIO Clara Campal
Madrid, 28050
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Instituto Valenciano de Oncología
Valencia, 46009
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
United States4 sites, 4 recruiting
- Not yet recruiting
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
John Theurer Cancer Center
Hackensack, New Jersey, 07601
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Valkyrie Clinical Trials
Los Angeles, California, 90067
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Yale University School of Medicine
New Haven, Connecticut, 06511
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Japan3 sites, 3 recruiting
- Recruiting
National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Saitama Medical University International Medical Center
Saitama, Hidaka, 350-1298
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
South Korea3 sites, 3 recruiting
- Not yet recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Not yet recruiting
Severance Hospital
Seoul, 03722
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Not yet recruiting
Asan Medical Center
Seoul, 05505
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
United Kingdom3 sites, 3 recruiting
- Recruiting
The Royal Marsden Hospital, Chelsea
London, SW3 6JJ
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
Churchill Hospital
Oxford, OX3 7LE
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
The Royal Marsden Hospital, Sutton
Sutton, SM2 5PT
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Taiwan2 sites, 2 recruiting
- Not yet recruiting
National Cheng Kung University Hospital
Tainan, 70403
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Not yet recruiting
National Taiwan University Hospital
Taipei, 10002
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
About this study
Official title: Phase Ia, First in Human Open Label Dose Escalation Trial Evaluating Intravenous BI 1703880 in Combination With Intravenous Ezabenlimab for Treatment of Advanced Solid Tumours
This study is open to adults with different types of advanced cancer. People can take part if previous treatment was not successful, or no treatment exists.
The purpose of this study is to find the highest dose of a medicine called BI 1703880 that people with advanced cancer can tolerate when taken together with ezabenlimab.
Read more
BI 1703880 and ezabenlimab are medicines that may help the immune system fight cancer. In this study, BI 1703880 is given to people for the first time.
Participants get BI 1703880 and ezabenlimab as infusions into a vein. During the first 6 weeks, they get BI 1703880 once a week. Later, they get BI 1703880 every 3 weeks. After the first 3 weeks, they get ezabenlimab in addition every 3 weeks.
Participants can get BI 1703880 for up to 1 year and ezabenlimab for up to 2 years as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. At these visits, the doctors check participants' health and take note of any unwanted effects.
- Conditions
- Solid Tumors
- Being tested
- BI 1703880, Ezabenlimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1703880Drug
BI 1703880
EzabenlimabDrug
Also called BI 754091
Ezabenlimab
| Study group | Role | What they receive |
|---|---|---|
| BI 1703880 (Cycle 1) then BI 1703880 + ezabenlimab (Cycle 2 onwards) | Experimental | Not described Receives: Drug: BI 1703880; 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 maximum tolerated dose (MTD) evaluation period
Measured: up to 6 weeks
Secondary outcomes (3)
Occurrence of DLTs during the on-treatment period
Measured: up to 804 days
Maximum measured concentration of BI 1703880 in plasma (Cmax)
Measured: up to 804 days
Area under the concentration-time curve of BI 1703880 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Measured: up to 804 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start24 Feb 2023
- Primary completion13 Sep 2028 (estimated)
- Study completion2 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 66 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
- NCT05471856
- Sponsor's protocol ID
- 1480-0001
- Other IDs
- 2022-000298-22, U1111-1303-5359, 2024-511501-37-00
- Status last verified
- Oct 2026
- First submitted
- 21 Jul 2022
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- 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: URL: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Publications
Harrington K, Kitano S, Gambardella V, Parkes EE, Moreno I, Alonso G, Doi T, Berz D, Gutierrez ME, Fernandez N, Schmohl M, Barrueco J, LoRusso P. Open-label, phase Ia study of STING agonist BI 1703880 plus ezabenlimab for patients with advanced solid tumors. Future Oncol. 2025 Jan;21(2):195-200. doi: 10.1080/14796694.2024.2441107. Epub 2025 Jan 16.
PubMed 39817655
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ia, First in Human Open Label Dose Escalation Trial Evaluating Intravenous BI 1703880 in Combination With Intravenous Ezabenlimab for Treatment of Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT05471856
- Acronym / sponsor ID
- 1480-0001
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 13 Sep 2028 (estimated)
- Study completion
- 2 Jan 2029 (estimated)
- First posted
- 25 Jul 2022 (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 different types of advanced cancer. People can take part if previous treatment was not successful, or no treatment exists.
The purpose of this study is to find the highest dose of a medicine called BI 1703880 that people with advanced cancer can tolerate when taken together with ezabenlimab.
BI 1703880 and ezabenlimab are medicines that may help the immune system fight cancer. In this study, BI 1703880 is given to people for the first time.
Participants get BI 1703880 and ezabenlimab as infusions into a vein. During the first 6 weeks, they get BI 1703880 once a week. Later, they get BI 1703880 every 3 weeks. After the first 3 weeks, they get ezabenlimab in addition every 3 weeks.
Participants can get BI 1703880 for up to 1 year and ezabenlimab for up to 2 years as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. At these visits, the doctors check participants' health and take note of any unwanted effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BI 1703880 (Cycle 1) then BI 1703880 + ezabenlimab (Cycle 2 onwards) | Experimental | Drug: BI 1703880, Drug: Ezabenlimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic or relapsed/refractory solid tumour. Patient must have at least one measurable lesion (according to Response Criteria in Solid Tumours (RECIST 1.1)).
- Patient must have exhausted or refused established treatment options for the malignant disease, or is not eligible for established treatment options.
- Has a lesion amenable to pre-treatment and on-treatment biopsy and patient consents to both biopsies.
- Medically fit and willing to undergo all mandatory trial procedures.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Key exclusion criteria (9 listed)
- Any investigational or antitumour treatment within 4 weeks or 5 half-life periods prior to the first treatment whichever is shorter.
- Prior STING agonist therapy.
- Prior intolerability of a anti-programmed cell death protein 1 (PD-1) or anti-programmed cell death ligand 1 (PD-L1) therapy.
- History of allergy or hypersensitivity to study agent components.
- Immunosuppressive therapies including, but not limited to, systemic corticosteroids at doses exceeding >10 mg/day of prednisone or equivalent, and tumour necrosis factor-alpha blockers.
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 1703880BI 1703880 | Drug | BI 1703880 (Cycle 1) then BI 1703880 + ezabenlimab (Cycle 2 onwards) |
| EzabenlimabAlso: BI 754091Ezabenlimab | Drug | BI 1703880 (Cycle 1) then BI 1703880 + ezabenlimab (Cycle 2 onwards) |
Primary outcome
Occurrence of dose limiting toxicities (DLTs) during the maximum tolerated dose (MTD) evaluation period
Time frame: up to 6 weeks
3 secondary outcomes
Occurrence of DLTs during the on-treatment period
Time frame: up to 804 days
Maximum measured concentration of BI 1703880 in plasma (Cmax)
Time frame: up to 804 days
Area under the concentration-time curve of BI 1703880 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: up to 804 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 2 Nov 2026.
- Derived from this study: PubMed 39817655Harrington K, Kitano S, Gambardella V, Parkes EE, Moreno I, Alonso G, Doi T, Berz D, Gutierrez ME, Fernandez N, Schmohl M, Barrueco J, LoRusso P. Open-label, phase Ia study of STING agonist BI 1703880 plus ezabenlimab for patients with advanced solid tumors. Future Oncol. 2025 Jan;21(2):195-200. doi: 10.1080/14796694.2024.2441107. Epub 2025 Jan 16.
- 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: URL: 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.
21 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 1703880 and Ezabenlimab in people with Solid Tumors, run by Boehringer Ingelheim at 21 sites in 6 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 15 inclusion and 9 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Spain, United States, Japan, South Korea, United Kingdom and 1 more country. 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) during the maximum tolerated dose (MTD) evaluation period (time frame: up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05471856, which also lists 1 linked publication.
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 2 Nov 2026.