Solid TumoursPhase 1NCT07224425
A Study of BI 3810944 in Patients With Advanced Cancer
A Phase 1 study testing BI 3810944 in people with Solid Tumours and Melanoma, run by Boehringer Ingelheim at 7 sites in 3 countries.
Trial summary
This study is open to adults with advanced cancer (solid tumours) for whom previous treatment was not successful, or no treatment exists. The study tests different doses of BI 3810944 to find out which doses they can tolerate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumours, Melanoma
- What is being tested?
- BI 3810944
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 24 Feb 2026to 5 Oct 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
- Trial participant population specifically to Part A and B:
- Part A only: participants with any histologically or cytologically confirmed diagnosis of solid tumour who failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Participant must have exhausted available treatment options known to prolong survival for their disease.
- Part B only: participants with histologically or cytologically confirmed diagnosis of who has progressed on, or is intolerant to available standard therapies, or for whom no standard therapy with proven benefit exists according to the local and institutional guidelines. Participants should not have received >3 previous lines of treatment (excluding prior systemic regimens received at adjuvant or neoadjuvant setting and excluding treatment with tumour-infiltrating lymphocytes at any timepoint). B-raf protein kinase (BRAF) mutation status must be known prior to screening
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- Presence of at least one measurable lesion outside of central nervous system (CNS) as defined per response evaluation criteria in solid tumours (RECIST v 1.1)
- Age ≥18 years
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- Adequate organ function
- Life expectancy of ≥3 months at the start of the trial treatment in the opinion of the investigator
- All toxicities related to previous anticancer therapies have resolved to common terminology criteria for adverse events (CTCAE) Grade ≤1 prior to trial treatment administration (except for alopecia and peripheral neuropathy which must be CTCAE Grade ≤2 and amenorrhea/menstrual disorders which can be any Grade) Further inclusion criteria apply.
Who cannot join
- Active primary central nervous system (CNS) malignancy, active untreated CNS metastases and/or carcinomatous meningitis
- Participants with asymptomatic (i.e. no clinical neurological symptoms) brain lesions are eligible provided they meet the following criteria:
- Radiotherapy or surgery for brain metastases was completed ≥2 weeks before the first administration of BI 3810944
- Patient is off steroids for ≥7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for ≥7 days or on stable doses of anti-epileptic drugs for malignant CNS disease
- A diagnosis of immunodeficiency; receiving chronic systemic therapy exceeding prednisone 10 mg daily or equivalent or any other form of immunosuppressive therapy within 7 days before the step-up dose of BI 3810944
- Prior anticancer therapy:
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- Participants who have been treated with any other anticancer drug(s), within 28 days or within 5 half-life periods (whichever is shorter) prior to the first administration of BI 3810944
- Participants who have been treated with extensive field radiotherapy including whole brain irradiation, within 2 weeks prior to first administration of BI 3810944
- Prior treatment with organ transplant or allogenic hematopoietic stem-cell transplant
- Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed (e.g. biopsy)
- Women who are pregnant, breastfeeding or who plan to become pregnant or breastfeeding during the trial or within 4 months after the last dose of BI 3810944 Further exclusion criteria apply.
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
United States4 sites, 4 recruiting
- Not yet recruiting
University of Virginia Health System
Charlottesville, Virginia, 22908
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
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Tennessee Oncology, PLLC - Elliston Place Plaza DDU
Nashville, Tennessee, 37203
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Belgium2 sites, 2 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Recruiting
UZ Leuven
Leuven, 3000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Netherlands1 site, 1 recruiting
- Recruiting
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GA
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
About this study
Official title: A First-in-human, Phase I, Open-label, Non-randomized, Multicentre Dose Escalation and Expansion Trial of BI 3810944 in Patients With Solid Tumours and Melanoma
This study is open to adults with advanced cancer (solid tumours) for whom previous treatment was not successful, or no treatment exists. The study tests different doses of BI 3810944 to find out which doses they can tolerate. Another purpose is to identify the most suitable dose of BI 3810944 and to find out whether it helps people with advanced cancer.
Participants get BI 3810944 usually once every 3 weeks. At treatment start, it is given once a week for a short time. Participants may continue to get BI 3810944 as long as they benefit from treatment. The treatment duration is planned for 2 years. During this time, they regularly visit the study site. The first study visits include overnight stays at the hospital. At the visits, study doctors check participants' health, take necessary laboratory tests, and note any unwanted effects.
The doctors also regularly check the size of the tumour with imaging methods.
- Conditions
- Solid Tumours, Melanoma
- Being tested
- BI 3810944
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 3810944Drug
BI 3810944
| Study group | Role | What they receive |
|---|---|---|
| Part A: Dose escalation | Experimental | Not described Receives: Drug: BI 3810944 |
| Part B: Dose expansion | Experimental | Not described Receives: Drug: BI 3810944 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A (dose escalation): Occurrence of Cytokine Release Syndrome (CRS) Grade 1 or 2 during the primary Dose Limiting Toxicity (DLT) evaluation period, as a sign of minimal immunological activity that primes the immune system
Measured: approximately 2 months
Part A (dose escalation): Occurrence of DLTs during the primary DLT evaluation period
Measured: approximately 2 months
Part B (dose expansion): Objective Response (OR)
OR, defined as best overall response of confirmed CR and/or confirmed PR, where best overall response is determined according to RECIST v 1.1 assessed from first treatment administration until the earliest event of PD, death or last evaluable tumour assessment during the on-treatment period before start of subsequent anticancer therapy, loss to follow up, withdrawal of consent, or end of trial.
Measured: up to 24 months
Secondary outcomes (9)
Part A (dose escalation): Occurrence of DLTs during the on-treatment period
Measured: approximately 2 months
Part A (dose escalation): Occurrence of Adverse Events (AEs) (including SAEs, drug-related AEs, AESIs, and AEs leading to discontinuation of trial drug) during the on-treatment period
Serious Adverse Events (SAEs); Adverse Event of Special Interest (AESIs).
Measured: approximately 2 months
Part B (dose expansion): Occurrence of AEs (including SAEs, drug-related AEs, AESIs, and AEs leading to discontinuation of trial drug) during the on-treatment period
Measured: up to 24 months
Part B (dose expansion): Duration of Response (DoR)
DoR, defined as the time from first documented Complete Response (CR) or Partial Response (PR) until the earliest of Progressive Disease (PD) or death among trial participants with OR according to RECIST v 1.1.
Measured: up to 24 months
Part B (dose expansion): Disease Control (DC)
DC, defined as best overall response of confirmed CR, or confirmed PR, or Stable Disease (SD) where best overall response is defined according to RECIST v 1.1 from first treatment administration until the earliest of PD, death or last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow-up, withdrawal of consent, or end of trial.
Measured: up to 24 months
Part B (dose expansion): Progression-Free Survival (PFS)
PFS, defined as the time from first administration until tumour progression according to RECIST v 1.1 or death from any cause, whichever occurs earlier.
Measured: up to 24 months
Part A (dose escalation) and Part B (dose expansion): Maximum measured concentration of analytes in serum (Cmax)
Measured: up to 24 months
Part A (dose escalation) and Part B (dose expansion): Area under the serum concentration-time curve over the time interval from 0 to the last measured time point, tz (AUC0-tz)
Measured: up to 24 months
Part A (dose escalation) and Part B (dose expansion): Terminal half-life of analytes (t1/2)
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2025
- Study start24 Feb 2026
- Primary completion5 Oct 2029 (estimated)
- Study completion5 Oct 2029 (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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Part A: Dose escalation, Part B: Dose expansion
- Masking
- None (open label)
- Enrolment
- 69 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
- NCT07224425
- Sponsor's protocol ID
- 1527-0001
- Other IDs
- 2025-522045-21-00, U1111-1323-2127, 2025
- Status last verified
- Oct 2026
- First submitted
- 3 Nov 2025
- Last updated
- 30 Oct 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: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Phase I, Open-label, Non-randomized, Multicentre Dose Escalation and Expansion Trial of BI 3810944 in Patients With Solid Tumours and Melanoma
- ClinicalTrials.gov ID
- NCT07224425
- Acronym / sponsor ID
- 1527-0001
- Conditions
- Solid Tumours, Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 5 Oct 2029 (estimated)
- Study completion
- 5 Oct 2029 (estimated)
- First posted
- 4 Nov 2025 (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 (solid tumours) for whom previous treatment was not successful, or no treatment exists. The study tests different doses of BI 3810944 to find out which doses they can tolerate. Another purpose is to identify the most suitable dose of BI 3810944 and to find out whether it helps people with advanced cancer.
Participants get BI 3810944 usually once every 3 weeks. At treatment start, it is given once a week for a short time. Participants may continue to get BI 3810944 as long as they benefit from treatment. The treatment duration is planned for 2 years. During this time, they regularly visit the study site. The first study visits include overnight stays at the hospital. At the visits, study doctors check participants' health, take necessary laboratory tests, and note any unwanted effects.
The doctors also regularly check the size of the tumour with imaging methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Part A: Dose escalation, Part B: Dose expansion
| Arm | Type | Receives |
|---|---|---|
| Part A: Dose escalation | Experimental | Drug: BI 3810944 |
| Part B: Dose expansion | Experimental | Drug: BI 3810944 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Trial participant population specifically to Part A and B:
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- Presence of at least one measurable lesion outside of central nervous system (CNS) as defined per response evaluation criteria in solid tumours (RECIST v 1.1)
- Age ≥18 years
- Adequate organ function
Key exclusion criteria (11 listed)
- Active primary central nervous system (CNS) malignancy, active untreated CNS metastases and/or carcinomatous meningitis
- A diagnosis of immunodeficiency; receiving chronic systemic therapy exceeding prednisone 10 mg daily or equivalent or any other form of immunosuppressive therapy within 7 days before the step-up dose of BI 3810944
- Prior anticancer therapy:
- Prior treatment with organ transplant or allogenic hematopoietic stem-cell transplant
- Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed (e.g. biopsy)
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 3810944BI 3810944 | Drug | Part A: Dose escalation, Part B: Dose expansion |
Primary outcome
Part A (dose escalation): Occurrence of Cytokine Release Syndrome (CRS) Grade 1 or 2 during the primary Dose Limiting Toxicity (DLT) evaluation period, as a sign of minimal immunological activity that primes the immune system
Time frame: approximately 2 months
Part A (dose escalation): Occurrence of DLTs during the primary DLT evaluation period
Time frame: approximately 2 months
Part B (dose expansion): Objective Response (OR)
Time frame: up to 24 months
OR, defined as best overall response of confirmed CR and/or confirmed PR, where best overall response is determined according to RECIST v 1.1 assessed from first treatment administration until the earliest event of PD, death or last evaluable tumour assessment during the on-treatment period before start of subsequent anticancer therapy, loss to follow up, withdrawal of consent, or end of trial.
9 secondary outcomes
Part A (dose escalation): Occurrence of DLTs during the on-treatment period
Time frame: approximately 2 months
Part A (dose escalation): Occurrence of Adverse Events (AEs) (including SAEs, drug-related AEs, AESIs, and AEs leading to discontinuation of trial drug) during the on-treatment period
Time frame: approximately 2 months
Part B (dose expansion): Occurrence of AEs (including SAEs, drug-related AEs, AESIs, and AEs leading to discontinuation of trial drug) during the on-treatment period
Time frame: up to 24 months
Part B (dose expansion): Duration of Response (DoR)
Time frame: up to 24 months
Part B (dose expansion): Disease Control (DC)
Time frame: up to 24 months
Part B (dose expansion): Progression-Free Survival (PFS)
Time frame: up to 24 months
Part A (dose escalation) and Part B (dose expansion): Maximum measured concentration of analytes in serum (Cmax)
Time frame: up to 24 months
Part A (dose escalation) and Part B (dose expansion): Area under the serum concentration-time curve over the time interval from 0 to the last measured time point, tz (AUC0-tz)
Time frame: up to 24 months
Part A (dose escalation) and Part B (dose expansion): Terminal half-life of analytes (t1/2)
Time frame: up to 24 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 30 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.
7 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 3810944 in people with Solid Tumours and Melanoma, run by Boehringer Ingelheim at 7 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 11 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 30 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 7 sites in United States, 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?
Part A (dose escalation): Occurrence of Cytokine Release Syndrome (CRS) Grade 1 or 2 during the primary Dose Limiting Toxicity (DLT) evaluation period, as a sign of minimal immunological activity that primes the immune system (time frame: approximately 2 months). The study lists 3 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 30 Oct 2026.