A Study of BI 4015092, Alone or in Combination With Other Cancer Treatment, in Patients With Advanced Cancer That Has a KRAS G12D Mutation
Open the official record
This page only displays public information reproduced from the official ClinicalTrials.gov record NCT07926334. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Open-label, Multicenter, First-in-human Trial to Explore Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BI 4015092 as Monotherapy and as Combination Therapy in Patients With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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. * In Part A1, small groups of participants receive BI 4015092 alone, and the dose is slowly increased to find a suitable dose that people can tolerate. * In Part A2, participants receive BI 4015092 alone at a selected dose to further check how well people tolerate it and to look for early signs that it can stop tumours from growing or make them shrink. * In Part B1, participants receive BI 4015092 together with cetuximab, and the dose of BI 4015092 is slowly increased to find a suitable dose for the combination. * In Part B2, participants receive BI 4015092 together with cetuximab. In this part, participants are put into groups by chance, like drawing names from a hat, and each group gets a different dose of BI 4015092 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.
Study identification
- NCT ID
- NCT07926334
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 200 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 7, 2026 (Estimated)
- Primary completion
- Nov 5, 2032 (Estimated)
- Completion
- Nov 5, 2032 (Estimated)
- Last update posted
- Nov 9, 2026
2026 – 2032
United States locations
- U.S. sites
- 3
- U.S. states
- 2
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Yale Cancer Center | New Haven | Connecticut | 06511 | — |
| Sarah Cannon Research Institute at Mary Crowley | Dallas | Texas | 75230 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07926334, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 9, 2026 · Synced Nov 12, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.