Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma

NCT05874414 · View on ClinicalTrials.gov ↗

Study Summary

This is an open-label, multicenter Phase 1b/2a study to evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of GNS561 in combination with trametinib in Advanced KRAS Mutated Cholangiocarcinoma after failure of standard-of-care first line therapy

Conditions Studied

Interventions

  • DRUG GNS561 + Trametinib

Study Locations (11)

California

  • USC Norris Comprehensive Cancer Center — Los Angeles
  • LA Cancer Network — Los Angeles

Florida

  • Orlando Health — Orlando
  • Moffitt Cancer Center — Tampa

Illinois

  • University Of Chicago Medical Center — Chicago

New York

  • Roswell Park Cancer Institute — Buffalo

Pennsylvania

  • Hospital of the University of Pennsylvania — Philadelphia

Texas

  • University of Texas, MD Anderson Cancer Center — Houston

Virginia

  • University of Virginia Comprehensive Cancer Center — Charlottesville

Wisconsin

  • Froedtert Hospital and the Medical College of Wisconsin — Milwaukee

Trial Details

FieldValue
Enrollment Target 74 participants
Start Date 2023-08-21
Est. Completion 2026-10
Phase Phase 1

Sponsor

Genfit

34 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05874414

The ClinicalTrials.gov registry entry for NCT05874414 describes a study currently listed as 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 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genfit, which has 34 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 Cholangiocarcinoma appearing as the primary indexed condition, and to 1 intervention — of which GNS561 + 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: NCT05874414 reports 11 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Illinois. 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 NCT05874414 about?

NCT05874414 is a clinical study titled "Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma". This is an open-label, multicenter Phase 1b/2a study to evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of GNS561 in combination with trametinib in Advanced KRAS Mutated Cholangiocarcinoma after failure of standard-of-care first line therapy

What is the current status of trial NCT05874414?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2023-08-21. Estimated completion is 2026-10.

What conditions does trial NCT05874414 study?

This clinical trial studies the following conditions: Cholangiocarcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05874414?

The interventions under investigation include: GNS561 + Trametinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05874414?

This trial is sponsored by Genfit, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05874414 being conducted?

This trial has 11 study locations across California, Florida, Illinois, New York, Pennsylvania. 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