Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05874414 · ClinicalTrials.gov registry record · Phase 1
Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma
A Phase 1 study of Cholangiocarcinoma, sponsored by Genfit.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
- 11
- Study locations
NCT05874414 is a Phase 1 study of Cholangiocarcinoma that is actively recruiting participants, run by Genfit. The registered enrollment target is 74 participants, below the 385-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (81% lower). The trial reports 11 study locations across 9 states.
The verdict
NCT05874414, a Phase 1 study of Cholangiocarcinoma, is actively recruiting participants, sponsored by Genfit.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
- 11
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2023-08-21 |
| Est. Completion | 2026-10 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 385-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (81% lower). The listed sponsor is Genfit, which has 11 total studies on file at ClinicalTrials.gov.
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.
NCT05874414 reports 11 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Illinois.
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.
What interventions are being tested in trial NCT05874414?
The interventions under investigation include: GNS561 + Trametinib (DRUG).
Who is sponsoring clinical trial NCT05874414?
This trial is sponsored by Genfit, which has 11 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Cholangiocarcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study of LY4337713 in Participants With FAP-Positive Solid Tumors
RECRUITING · Phase 1
-
Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers
RECRUITING · Phase 1
-
Pemigatinib + Afatinib in Advanced Refractory Solid Tumors
RECRUITING · Phase 1
-
A Study of MGC028 in Participants With Advanced Solid Tumors
RECRUITING · Phase 1
-
Evaluating Efficacy of Tivozanib (AV-951) in Biliary Tract Cancers
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.