Solid TumoursPhase 1NCT07744152
A Study to Test How Well Different Doses of BI 3822971 Are Tolerated by People With Advanced Cancer (Solid Tumours)
A Phase 1 study testing BI 3822971 in people with Solid Tumours, run by Boehringer Ingelheim at 11 sites in 5 countries.
Trial summary
This study is open to adults with advanced or metastatic solid cancer, such as non-small cell lung cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, esophageal squamous cell carcinoma, bladder cancer, vulvar cancer, and cervical cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumours
- What is being tested?
- BI 3822971
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 21 Sep 2026to 15 Jan 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
- Patients must have histologically confirmed unresectable advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell cancer (HNSCC), triple negative breast cancer (TNBC), esophageal squamous cell cancer (ESCC), bladder cancer (BC), vulvar cancer (VC) and cervical cancer (CC) and have no remaining standard treatment options (including those who have failed or are intolerant to standard therapy).
- Patients ≥18 years of age and over the legal age of consent as required by local legislation at the time of signature of the informed consent form (ICF).
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patient must have at least one measurable lesion outside of the central nervous system (CNS) as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Tumour lesions that have been irradiated ≥28 days before the start of treatment, and have subsequently had documented progression, may be chosen as measurable lesions only in the absence of measurable lesions that have not been irradiated.
- Further inclusion criteria apply.
Who cannot join
- Prior treatment with systemic anticancer drugs within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of study intervention.
- Treatment with extensive field radiotherapy including whole brain irradiation within 14 days prior to first administration.
- Patient has a diagnosis of immunodeficiency other than human immunodeficiency virus (HIV).
- History or presence of cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of III or IV, corrected QT (QTc) prolongation > 480 msec, unstable angina or poorly controlled arrhythmia which are considered as clinically relevant by the Investigator.
- Myocardial infarction, stroke, or pulmonary embolism within 6 months prior to treatment.
- Further exclusion criteria apply.
Trial locations and contacts
11 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 5 countries
Spain5 sites, 5 recruiting
- Recruiting
Hospital del Mar
Barcelona, 08003
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Clínica Universidad de Navarra
Navarra, 31008
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
China2 sites, 2 recruiting
- Not yet recruiting
Beijing Cancer Hospital
Beijing, 100142
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Shanghai East Hospital
Shanghai, 200123
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Germany2 sites, 2 recruiting
- Not yet recruiting
Technische Universität Dresden
Dresden, 01307
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Klinikum der Universität München AÖR
München, 81377
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Belgium1 site, 1 recruiting
- Not yet recruiting
UZ Leuven
Leuven, 3000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Netherlands1 site, 1 recruiting
- Not yet recruiting
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
Amsterdam, 1066CX
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
About this study
Official title: A First-in-human, Open-label, Phase I Trial to Determine the Safety and Tolerability of BI 3822971 in Patients With Unresectable Advanced or Metastatic Solid Cancers
This study is open to adults with advanced or metastatic solid cancer, such as non-small cell lung cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, esophageal squamous cell carcinoma, bladder cancer, vulvar cancer, and cervical cancer. People can join the study if they have no remaining standard treatment options and have a measurable lesion outside the central nervous system. The purpose of this study is to find out how well a medicine called BI 3822971 is tolerated in people with these cancers. Researchers also want to find a dose and dosing schedule of BI 3822971 that is safe and is well tolerated.
In this study, BI 3822971 is given to humans for the first time. BI 3822971 is being developed to help the immune system fight cancer. This schedule can change during the course of the trial depending on the data generated. All participants receive the study medicine (there is no randomization and no placebo group). Participants visit the study site and may need to stay overnight for observation, especially on days when the medicine is administered.
Participants can stay in the study for up to 3 years as long as they benefit from treatment and can tolerate it. During this time, doctors regularly check the size of the tumour. The doctors also regularly check participants' health and take note of any unwanted effects. They collect information on any health problems of the participants and take blood samples.
- Conditions
- Solid Tumours
- Being tested
- BI 3822971
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 3822971Drug
BI 3822971
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation (all participants) | Experimental | Not described Receives: Drug: BI 3822971 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of treatment-emergent adverse events (AEs)
Measured: up to 36 months
Occurrence of dose limiting toxicities (DLTs)
Measured: up to 36 months
Secondary outcomes (2)
Maximum measured concentration (Cmax) of BI 3822971 in plasma
Measured: up to 36 months
Area under the concentration-time curve (AUC) of BI 3822971 in plasma
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start21 Sep 2026
- Primary completion15 Jan 2030 (estimated)
- Study completion15 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumoursStudies 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
- Model description
- sequential cohorts with escalating doses
- Masking
- None (open label)
- Enrolment
- 137 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
- NCT07744152
- Sponsor's protocol ID
- 2015-0001
- Other IDs
- U1111-1337-2013, 2026-525785-22-00
- Status last verified
- Oct 2026
- First submitted
- 30 Jul 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Open-label, Phase I Trial to Determine the Safety and Tolerability of BI 3822971 in Patients With Unresectable Advanced or Metastatic Solid Cancers
- ClinicalTrials.gov ID
- NCT07744152
- Acronym / sponsor ID
- 2015-0001
- Conditions
- Solid Tumours
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2026 (actual)
- Primary completion
- 15 Jan 2030 (estimated)
- Study completion
- 15 Jan 2030 (estimated)
- First posted
- 4 Aug 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 or metastatic solid cancer, such as non-small cell lung cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, esophageal squamous cell carcinoma, bladder cancer, vulvar cancer, and cervical cancer. People can join the study if they have no remaining standard treatment options and have a measurable lesion outside the central nervous system. The purpose of this study is to find out how well a medicine called BI 3822971 is tolerated in people with these cancers. Researchers also want to find a dose and dosing schedule of BI 3822971 that is safe and is well tolerated.
In this study, BI 3822971 is given to humans for the first time. BI 3822971 is being developed to help the immune system fight cancer. This schedule can change during the course of the trial depending on the data generated. All participants receive the study medicine (there is no randomization and no placebo group). Participants visit the study site and may need to stay overnight for observation, especially on days when the medicine is administered.
Participants can stay in the study for up to 3 years as long as they benefit from treatment and can tolerate it. During this time, doctors regularly check the size of the tumour. The doctors also regularly check participants' health and take note of any unwanted effects. They collect information on any health problems of the participants and take blood samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- sequential cohorts with escalating doses
| Arm | Type | Receives |
|---|---|---|
| Dose escalation (all participants) | Experimental | Drug: BI 3822971 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have histologically confirmed unresectable advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell cancer (HNSCC), triple negative breast cancer (TNBC), esophageal squamous cell cancer (ESCC), bladder cancer (BC), vulvar cancer (VC) and cervical cancer (CC) and have no remaining standard treatment options (including those who have failed or are intolerant to standard therapy).
- Patients ≥18 years of age and over the legal age of consent as required by local legislation at the time of signature of the informed consent form (ICF).
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patient must have at least one measurable lesion outside of the central nervous system (CNS) as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Tumour lesions that have been irradiated ≥28 days before the start of treatment, and have subsequently had documented progression, may be chosen as measurable lesions only in the absence of measurable lesions that have not been irradiated.
- Further inclusion criteria apply.
Key exclusion criteria (6 listed)
- Prior treatment with systemic anticancer drugs within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of study intervention.
- Treatment with extensive field radiotherapy including whole brain irradiation within 14 days prior to first administration.
- Patient has a diagnosis of immunodeficiency other than human immunodeficiency virus (HIV).
- History or presence of cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of III or IV, corrected QT (QTc) prolongation > 480 msec, unstable angina or poorly controlled arrhythmia which are considered as clinically relevant by the Investigator.
- Myocardial infarction, stroke, or pulmonary embolism within 6 months prior to treatment.
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 3822971BI 3822971 | Drug | Dose escalation (all participants) |
Primary outcome
Occurrence of treatment-emergent adverse events (AEs)
Time frame: up to 36 months
Occurrence of dose limiting toxicities (DLTs)
Time frame: up to 36 months
2 secondary outcomes
Maximum measured concentration (Cmax) of BI 3822971 in plasma
Time frame: up to 36 months
Area under the concentration-time curve (AUC) of BI 3822971 in plasma
Time frame: up to 36 months
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 27 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.
11 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 3822971 in people with Solid Tumours, run by Boehringer Ingelheim at 11 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 5 inclusion and 6 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 27 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 11 sites in Spain, China, Germany, Belgium, Netherlands. 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 treatment-emergent adverse events (AEs) (time frame: up to 36 months). 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 27 Oct 2026.