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ACTIVE NOT RECRUITING 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)

NCT04111458 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 71 participants
Start Date 2019-11-04
Est. Completion 2027-12-31
Phase Phase 1

Sponsor

Boehringer Ingelheim

203 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04111458

The ClinicalTrials.gov registry entry for NCT04111458 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 71 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; SOS1 appearing as the primary indexed condition, and to 2 interventions — of which Trametinib 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: NCT04111458 reports 8 study locations spanning 5 distinct geographic areas — top geographies include Other, Massachusetts, North Carolina. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04111458?

The interventions under investigation include: Trametinib (DRUG), BI 1701963 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04111458?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial