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NCT04973163 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Solid Tumors, KRAS Mutation, sponsored by Boehringer Ingelheim.
- Active
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 9
- Study locations
NCT04973163: Active Phase 1 study of Solid Tumors, KRAS Mutation, sponsored by Boehringer Ingelheim.
NCT04973163 is a Phase 1 study of Solid Tumors, KRAS Mutation that is active but no longer recruiting, run by Boehringer Ingelheim. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). The trial reports 9 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04973163, a Phase 1 study of Solid Tumors, KRAS Mutation, is active but no longer recruiting, sponsored by Boehringer Ingelheim.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 9
- Study locations
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.
Primary Outcome
DLTs are graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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 |
What the registry record for NCT04973163 still lists
NCT04973163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
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.
NCT04973163 lists 9 locations in 3 states (Other, Texas, New York).
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.
What interventions are being tested in trial NCT04973163?
The interventions under investigation include: Midazolam (DRUG), BI 1701963 (DRUG), BI 1823911 (DRUG).
Who is sponsoring clinical trial NCT04973163?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04973163's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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