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A Study to Test Different Doses of BI 1823911 Alone and Combined With Other Medicines in People With Different Types of Advanced Cancer With KRAS Mutation
NCT04973163 · View on ClinicalTrials.gov ↗
Study Summary
This study is open to adults with different types of advanced or metastatic cancer (including lung cancer, colorectal cancer, pancreatic cancer, and bile duct cancer). This study is for people for whom previous treatment was not successful or no treatment exists. People who have a tumour with a KRAS mutation can participate in the study. A KRAS mutation makes tumours grow faster. BI 1823911 and BI 1701963 are medicines that may turn off KRAS, each in a different way. In this study, BI 1823911 is given to people for the first time. The purpose of this study is to find the highest dose of BI 1823911 that people can tolerate when taken alone and together with BI 1701963. The most suitable dose is used to find out whether BI 1823911 alone and in combination with BI 1701963 can make tumours shrink. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, participants take tablets of BI 1823911 alone or in combination with BI 1701963 once a day. The doctors regularly monitor the size of the tumour. Doctors also regularly record any unwanted effects and check participant's health.
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG BI 1701963
- DRUG BI 1823911
Study Locations (9)
Other
- Brussels - HOSP Jules Bordet — Anderlecht/Brussels-Capital
- Edegem - UNIV UZ Antwerpen — Edegem/Antwerpen
- Universitair Ziekenhuis Gent — Gent/Oost-Vlaanderen
- UZ Leuven — Leuven/Vlaams-Brabant
- Hospital Universitari Vall D Hebron — Barcelona
- The Christie — Manchester
Texas
- Sarah Cannon Research Institute at Mary Crowley — Dallas
- The University of Texas MD Anderson Cancer Center — Houston
New York
- Memorial Sloan-Kettering Cancer Center — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-09-09 |
| Est. Completion | 2026-12-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04973163
The ClinicalTrials.gov registry entry for NCT04973163 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Solid Tumors, KRAS Mutation appearing as the primary indexed condition, and to 3 interventions — of which Midazolam is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04973163 reports 9 study locations spanning 3 distinct geographic areas — top geographies include Other, Texas, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04973163 about?
NCT04973163 is a clinical study titled "A Study to Test Different Doses of BI 1823911 Alone and Combined With Other Medicines in People With Different Types of Advanced Cancer With KRAS Mutation". This study is open to adults with different types of advanced or metastatic cancer (including lung cancer, colorectal cancer, pancreatic cancer, and bile duct cancer). This study is for people for whom previous treatment was not successful or no treatment exists. People who have a tumour with a KRA...
What is the current status of trial NCT04973163?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2021-09-09. Estimated completion is 2026-12-27.
What conditions does trial NCT04973163 study?
This clinical trial studies the following conditions: Solid Tumors, KRAS Mutation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04973163?
The interventions under investigation include: Midazolam (DRUG), BI 1701963 (DRUG), BI 1823911 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04973163?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04973163 being conducted?
This trial has 9 study locations across New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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