Solid TumoursPhase 1NCT07827144
A Study to Test How Well Different Doses of BI 4060107 Are Tolerated by People With Advanced Cancer (Solid Tumours)
A Phase 1 study testing BI 4060107 in people with Solid Tumours, run by AIMEDBIO at 6 sites in 5 countries.
Trial summary
This study is open to adults with advanced cancer who have selected types of solid tumours that cannot be surgically removed. People can join the study if they have tried all available treatments and have no other options. 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 4060107
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 9 Oct 2026to 13 May 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
- A patient must be ≥18 years of age and at least at the legal age of consent in countries where it is older than 18 years at the time of signature on the Informed Consent Forms (ICFs)
- Signed and dated written main informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Patients with histologically or cytologically confirmed diagnosis of an unresectable advanced and/or metastatic or relapsed/refractory solid tumour.
- Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not eligible for established treatment options. The patient must have exhausted available treatment options as per local recommendations and reimbursement policies.
- Further inclusion criteria apply
Who cannot join
- Patients who have previously received an agent with the same target as the investigational medicinal product (IMP)
- Treatment with a systemic anti-cancer therapy, an investigational device or an investigational drug within 28 days or 5 half-lives (whichever is shorter) of the first administration of trial medication
- Radiotherapy within 28 days prior to first administration of trial medication except for palliative radiotherapy to regions other than the chest, or radiotherapy for brain metastases as described under the inclusion criteria in the protocol, is allowed if completed at least 14 days prior to first administration of trial medication
- Current enrolment in another investigational device or drug trial
- Further exclusion criteria apply
Trial locations and contacts
6 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 5 countries
South Korea2 sites, 2 recruiting
- Not yet recruiting
Seoul National University Hospital
Seoul, 03080
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Samsung Medical Center
Seoul, 06351
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
United States1 site, 1 recruiting
- Not yet recruiting
Texas Oncology - Irving
Irving, Texas, 75039
Boehringer Ingelheim, 18336022368, unitedstates@bitrialsupport.com
Australia1 site, 1 recruiting
- Not yet recruiting
Austin Health
Heidelberg, Victoria, 3048
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
France1 site, 1 recruiting
- Recruiting
Institut Gustave Roussy
Villejuif, 94800
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Japan1 site, 1 recruiting
- Recruiting
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
About this study
Official title: A First-in-human Phase I, Open-label, Multicentre Trial of i.v. Administrations of BI 4060107 in Patients With Unresectable Advanced and/or Metastatic Solid Tumours
This study is open to adults with advanced cancer who have selected types of solid tumours that cannot be surgically removed. People can join the study if they have tried all available treatments and have no other options. The purpose of this study is to find the highest dose of a medicine called BI 4060107 that people with advanced cancer can tolerate. In this study, BI 4060107 is given to humans for the first time.
Participants are divided into different dose groups based on when they join the study. Each participant within a dose group receives the same dose, with the lowest dose given to the first group. The next group receives a higher dose if the lower dose is tolerated.
Participants can stay in the study for up to 3 years if they benefit from the treatment and can tolerate it. During this time, they visit the study site regularly. After the first treatment, participants stay overnight for 1 night at the study site. At the visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 4060107.
- Conditions
- Solid Tumours
- Being tested
- BI 4060107
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 4060107Biological
BI 4060107
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: BI 4060107 dose level 1 | Experimental | Not described Receives: Biological: BI 4060107 |
| Cohort 2: BI 4060107 dose level 2 | Experimental | Not described Receives: Biological: BI 4060107 |
| Cohort 3: BI 4060107 dose level 3 | Experimental | Not described Receives: Biological: BI 4060107 |
| Cohort 4: BI 4060107 dose level 4 | Experimental | Not described Receives: Biological: BI 4060107 |
| Cohort 5: BI 4060107 dose level 5 | Experimental | Not described Receives: Biological: BI 4060107 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose limiting toxicity(ies) DLT(s) during the primary DLT evaluation period
Measured: up to 21 days
Secondary outcomes (14)
Occurrence of adverse events (AEs) during the on-treatment period
Measured: up to 36 months
Occurrence of AE fulfilling DLT criteria during the on-treatment period
Measured: up to 36 months
Maximum measured concentration (Cmax) of pharmacokinetic (PK) parameters of BI 4060107
(duration of a treatment cycle is 21 days; maximum treatment duration is 36 months)
Measured: up to 4 days per cycle
Cmax of analyte I
Measured: up to 4 days per cycle
Cmax of analyte II
Measured: up to 4 days per cycle
Cmax of analyte III
Measured: up to 4 days per cycle
Area under the concentration-time curve of PK parameters of BI 4060107 over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Measured: up to 4 days per cycle
Area under the concentration-time curve of analyte I over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Measured: up to 4 days per cycle
Area under the concentration-time curve of analyte II over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Measured: up to 4 days per cycle
Area under the concentration-time curve of analyte III over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Measured: up to 4 days per cycle
Area under the concentration-time curve of PK parameters of BI 4060107 over the dosing interval τ (AUCτ)
Measured: up to 4 days per cycle
Area under the concentration-time curve of analyte I over the dosing interval τ (AUCτ)
Measured: up to 4 days per cycle
Area under the concentration-time curve of analyte II over the dosing interval τ (AUCτ)
Measured: up to 4 days per cycle
Area under the concentration-time curve of analyte III over the dosing interval τ (AUCτ)
Measured: up to 4 days per cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start9 Oct 2026
- Primary completion13 May 2030 (estimated)
- Study completion13 May 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.
- 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
- Participants are enrolled into 5 successive cohorts receiving increasing dose levels. Additional participants may be enrolled at doses considered safe to further evaluate safety and tolerability.
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AIMEDBIO
- Sponsor type
- Other government
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827144
- Sponsor's protocol ID
- 2035-0001
- Status last verified
- Oct 2026
- First submitted
- 14 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
- No
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 Phase I, Open-label, Multicentre Trial of i.v. Administrations of BI 4060107 in Patients With Unresectable Advanced and/or Metastatic Solid Tumours
- ClinicalTrials.gov ID
- NCT07827144
- Acronym / sponsor ID
- 2035-0001
- Conditions
- Solid Tumours
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- AIMEDBIOOther government
- Collaborators
- Boehringer Ingelheim
- Study start
- 9 Oct 2026 (actual)
- Primary completion
- 13 May 2030 (estimated)
- Study completion
- 13 May 2030 (estimated)
- First posted
- 18 Sep 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 who have selected types of solid tumours that cannot be surgically removed. People can join the study if they have tried all available treatments and have no other options. The purpose of this study is to find the highest dose of a medicine called BI 4060107 that people with advanced cancer can tolerate. In this study, BI 4060107 is given to humans for the first time.
Participants are divided into different dose groups based on when they join the study. Each participant within a dose group receives the same dose, with the lowest dose given to the first group. The next group receives a higher dose if the lower dose is tolerated.
Participants can stay in the study for up to 3 years if they benefit from the treatment and can tolerate it. During this time, they visit the study site regularly. After the first treatment, participants stay overnight for 1 night at the study site. At the visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 4060107.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Participants are enrolled into 5 successive cohorts receiving increasing dose levels. Additional participants may be enrolled at doses considered safe to further evaluate safety and tolerability.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: BI 4060107 dose level 1 | Experimental | Biological: BI 4060107 |
| Cohort 2: BI 4060107 dose level 2 | Experimental | Biological: BI 4060107 |
| Cohort 3: BI 4060107 dose level 3 | Experimental | Biological: BI 4060107 |
| Cohort 4: BI 4060107 dose level 4 | Experimental | Biological: BI 4060107 |
| Cohort 5: BI 4060107 dose level 5 | Experimental | Biological: BI 4060107 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A patient must be ≥18 years of age and at least at the legal age of consent in countries where it is older than 18 years at the time of signature on the Informed Consent Forms (ICFs)
- Signed and dated written main informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Patients with histologically or cytologically confirmed diagnosis of an unresectable advanced and/or metastatic or relapsed/refractory solid tumour.
- Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not eligible for established treatment options. The patient must have exhausted available treatment options as per local recommendations and reimbursement policies.
- Further inclusion criteria apply
Key exclusion criteria (5 listed)
- Patients who have previously received an agent with the same target as the investigational medicinal product (IMP)
- Treatment with a systemic anti-cancer therapy, an investigational device or an investigational drug within 28 days or 5 half-lives (whichever is shorter) of the first administration of trial medication
- Radiotherapy within 28 days prior to first administration of trial medication except for palliative radiotherapy to regions other than the chest, or radiotherapy for brain metastases as described under the inclusion criteria in the protocol, is allowed if completed at least 14 days prior to first administration of trial medication
- Current enrolment in another investigational device or drug trial
- 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 4060107BI 4060107 | Biological | Cohort 1: BI 4060107 dose level 1, Cohort 2: BI 4060107 dose level 2, Cohort 3: BI 4060107 dose level 3, Cohort 4: BI 4060107 dose level 4, Cohort 5: BI 4060107 dose level 5 |
Primary outcome
Occurrence of dose limiting toxicity(ies) DLT(s) during the primary DLT evaluation period
Time frame: up to 21 days
14 secondary outcomes
Occurrence of adverse events (AEs) during the on-treatment period
Time frame: up to 36 months
Occurrence of AE fulfilling DLT criteria during the on-treatment period
Time frame: up to 36 months
Maximum measured concentration (Cmax) of pharmacokinetic (PK) parameters of BI 4060107
Time frame: up to 4 days per cycle
Cmax of analyte I
Time frame: up to 4 days per cycle
Cmax of analyte II
Time frame: up to 4 days per cycle
Cmax of analyte III
Time frame: up to 4 days per cycle
Area under the concentration-time curve of PK parameters of BI 4060107 over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: up to 4 days per cycle
Area under the concentration-time curve of analyte I over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: up to 4 days per cycle
Area under the concentration-time curve of analyte II over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: up to 4 days per cycle
Area under the concentration-time curve of analyte III over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: up to 4 days per cycle
Area under the concentration-time curve of PK parameters of BI 4060107 over the dosing interval τ (AUCτ)
Time frame: up to 4 days per cycle
Area under the concentration-time curve of analyte I over the dosing interval τ (AUCτ)
Time frame: up to 4 days per cycle
Area under the concentration-time curve of analyte II over the dosing interval τ (AUCτ)
Time frame: up to 4 days per cycle
Area under the concentration-time curve of analyte III over the dosing interval τ (AUCτ)
Time frame: up to 4 days per cycle
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.
- Individual participant dataSharing planned: No
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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.
6 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 4060107 in people with Solid Tumours, run by AIMEDBIO at 6 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 5 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 6 sites in South Korea, United States, Australia, 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 (18002430127, 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 toxicity(ies) DLT(s) during the primary DLT evaluation period (time frame: up to 21 days). 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.