A Phase 1 interventional study of BI 4060107 in Solid Tumours, sponsored by AIMEDBIO. Recruiting at 6 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by AIMEDBIO · Phase 1, Interventional, and Treatment
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.
This is the only study on the registry with AIMEDBIO as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: BI 4060107
Biological: BI 4060107
Biological: BI 4060107
Biological: BI 4060107
Biological: BI 4060107
BI 4060107
Occurrence of dose limiting toxicity(ies) DLT(s) during the primary DLT evaluation period
Time frame: up to 21 days
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
(duration of a treatment cycle is 21 days; maximum treatment duration is 36 months)
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
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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