A Phase 1 interventional study of BI 4015092 and Cetuximab in Advanced or Metastatic Solid Tumors With KRAS G12D Mutation, sponsored by Boehringer Ingelheim. Not yet recruiting at 11 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment
This study is for adults with advanced or metastatic solid tumours, including colorectal cancer and pancreatic ductal adenocarcinoma. People who have a tumour that has a KRAS G12D gene mutation can take part. This study is open for people for whom other treatment may not have worked or may not be suitable. The purpose of this study is to find out how well a new study medicine called BI 4015092 is tolerated and how it affects these tumours when used alone and together with another medicine called cetuximab. This is the first time BI 4015092 is given to humans.
This study has 4 parts. In all parts, participants receive BI 4015092, either alone or together with cetuximab.
Participants can stay in the study as long as they benefit from the treatment and can tolerate it. During this time, they visit the study site regularly. At these visits, study doctors check participants' health and collect information about any health problems. They also regularly check the size of the tumours and whether the cancer has spread to other parts of the body.
Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 62 are open to participants now.
Of its 167 completed or terminated interventional studies of FDA-regulated products, 123 (74%) have results posted.
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.
Patients with or cytologically confirmed diagnosis of locally advanced or solid tumors with the Kirsten rat sarcoma virus (KRAS) G12D mutation detected by a local test.
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.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: BI 4015092
Drug: BI 4015092 · Drug: Cetuximab
Drug: BI 4015092
Drug: BI 4015092 · Drug: Cetuximab
BI 4015092
Cetuximab
Dose escalation (DE) parts: Occurrence of dose limiting toxicities (DLTs) during the primary DLT evaluation period
Time frame: Up to 3 weeks
Monotherapy expansion part: Objective response (OR)
OR defined as the best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), where BOR is determined by the investigator's assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 from the first treatment administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anticancer therapy, lost to follow-up, or withdrawal of consent, whichever occurs first.
Time frame: Up to 36 months
Combination therapy randomized dose optimization (Combi RDO) part: OR
as defined above
Time frame: Up to 36 months
All trial parts: Occurrence of treatment-emergent adverse events (AEs)
Time frame: Up to 36 months
All trial parts: Occurrence of DLTs
Time frame: Up to 36 months
All trial parts: Occurrence of drug-related AEs
Time frame: Up to 36 months
All trial parts: Occurrence of treatment-emergent serious adverse events (SAEs)
Time frame: Up to 36 months
DE part: OR
as defined above
Time frame: Up to 36 months
Mono expansion part and Combi RDO part: Duration of response (DoR), based on RECIST v1.1
DoR defined as the time from first complete response (CR) or partial response (PR) until the earliest of progressive disease (PD) or death among patients with an OR, as defined above.
Time frame: Up to 36 months
Mono expansion part and Combi RDO part: Progression free survival (PFS)
PFS defined as the time from first treatment administration until tumor progression according to RECIST v1.1 or death from any cause, whichever occurs first.
Time frame: Up to 36 months
Mono expansion part and Combi RDO part: PFS at 6 months (PFS6)
PFS6 defined as being alive and without tumor progression at 6 months from first trial treatment.
Time frame: At 6 months
Mono expansion part and Combi RDO part: Clinical benefit (CB)
CB defined as achievement of best overall response (BOR) of CR or PR of any duration, or stable disease (SD) of at least 6 months according to RECIST v1.1 from the first administration of trial medication until the earliest of PD, death, last evaluable tumor assessment before the start of subsequent anticancer therapy, loss to follow-up, or withdrawal of consent, whichever occurs first.
Time frame: At 6 months
All trial parts: Disease control (DC), based on RECIST v1.1
DC defined as the best overall response of CR, PR, or SD from the first administration of trial medication until the earliest of PD, death, last evaluable tumor assessment before the start of subsequent anticancer therapy, loss to follow-up, or withdrawal of consent, whichever occurs first.
Time frame: Up to 36 months
All trial parts: Maximum measured concentration of the analyte in plasma (Cmax) (after the first dose in Cycle 1 and 2)
Time frame: Up to 36 months
All trial parts: Area under the concentration-time curve over a uniform dosing interval 0 - 24 h (AUC0-24) (Cycle 1) or τ (AUCτ) (Cycle 2) (after first administration in Cycle 1 or Cycle 2)
Time frame: Up to 36 months
DE part back fill cohorts: Changes from baseline in the transcript levels of genes controlled by the mitogen-activated protein kinase (MAPK) pathway, such as dual specificity phosphatase 6 (DUSP6)
Time frame: At baseline and between Cycle 1 Day 15 and Cycle 2 Day 1 or Day 2 (Treatment cycles are 21 days)
Plan to share: Yes — Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined on the website.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
Access criteria: For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Data sharing details ↗ · www.clinicalstudies.boehringer-ingelheim.com
Start is estimated for Dec 2026; primary completion for Nov 2032, 70 months later.
How these figures are worked out, and which studies are left out of them.
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 ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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