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NCT04111458 · ClinicalTrials.gov registry record · Phase 1
A Study to Test Different Doses of BI 1701963 Alone and Combined With Trametinib in Patients With Different Types of Advanced Cancer (Solid Tumours With KRAS Mutation)
A Phase 1 study of Solid Tumors, KRAS Mutation; SOS1, sponsored by Boehringer Ingelheim.
- Active
- Registry status
- Phase 1
- Development phase
- 71
- Enrollment target
- 8
- Study locations
NCT04111458: Active Phase 1 study of Solid Tumors, KRAS Mutation; SOS1, sponsored by Boehringer Ingelheim.
NCT04111458 is a Phase 1 study of Solid Tumors, KRAS Mutation; SOS1 that is active but no longer recruiting, run by Boehringer Ingelheim. The registered enrollment target is 71 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% higher). The trial reports 8 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04111458, a Phase 1 study of Solid Tumors, KRAS Mutation; SOS1, is active but no longer recruiting, sponsored by Boehringer Ingelheim.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 71 participants
- Enrollment target
- 8
- Study locations
Study Summary
This is a study in adults with advanced cancer (solid tumours) in whom previous chemotherapy was not successful. Only people who have a tumour with a KRAS mutation can participate in the study. A KRAS mutation makes cancer grow faster. The study tests 2 medicines called BI 1701963 and trametinib. BI 1701963 prevents reactivation of KRAS. In this study, BI 1701963 is given to humans for the first time. Trametinib is an approved medicine (MEK inhibitor). The purpose of this study is to find out the highest dose of BI 1701963 alone and in combination with trametinib the participants can tolerate. Another purpose is to check whether BI 1701963 in combination with trametinib is able to make tumours shrink. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they get tablets of BI 1701963 and trametinib once daily. The doctors regularly monitor the size of the tumour. Doctors also regularly record any unwanted effects and check participants' health.
Conditions Studied
Interventions
- DRUG Trametinib
- DRUG BI 1701963
Study Locations (8)
Other
- Universitätsklinikum Köln (AöR) - Cologne
- Universitätsklinikum Frankfurt - Frankfurt am Main
- Erasmus Medisch Centrum-ROTTERDAM-50697 - Rotterdam
- Universitair Medisch Centrum Utrecht - Utrecht
Massachusetts
- Dana-Farber Cancer Institute - Boston
North Carolina
- Levine Cancer Institute - Charlotte
Tennessee
- Sarah Cannon Research Institute-Nashville-48456 - Nashville
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2019-11-04 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04111458 still lists
NCT04111458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% higher).
The record links to 1 condition, with Solid Tumors, KRAS Mutation; SOS1 appearing as the primary indexed condition, and to 2 interventions - of which Trametinib is the first listed.
NCT04111458 lists 8 locations in 5 states (Other, Massachusetts, North Carolina).
Frequently Asked Questions
What is clinical trial NCT04111458 about?
NCT04111458 is a clinical study titled "A Study to Test Different Doses of BI 1701963 Alone and Combined With Trametinib in Patients With Different Types of Advanced Cancer (Solid Tumours With KRAS Mutation)". This is a study in adults with advanced cancer (solid tumours) in whom previous chemotherapy was not successful. Only people who have a tumour with a KRAS mutation can participate in the study. A KRAS mutation makes cancer grow faster. The study tests 2 medicines called BI 1701963 and trametinib. B...
What is the current status of trial NCT04111458?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2019-11-04. Estimated completion is 2027-12-31.
What conditions does trial NCT04111458 study?
This clinical trial studies the following conditions: Solid Tumors, KRAS Mutation; SOS1.
What interventions are being tested in trial NCT04111458?
The interventions under investigation include: Trametinib (DRUG), BI 1701963 (DRUG).
Who is sponsoring clinical trial NCT04111458?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04111458 being conducted?
This trial has 8 study locations across Massachusetts, North Carolina, Tennessee, 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 NCT04111458's enrollment target sits among peer trials
71 747th of 2000 higher than 1,252 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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