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

ClinicalTrials.gov ID: NCT05874414

Public ClinicalTrials.gov record NCT05874414. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 20, 2026, 1:06 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase 1b/2a Study of GNS561 in Combination With Trametinib in Advanced KRAS Mutated Cholangiocarcinoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID: NCT05874414
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Genfit; Industry
Enrollment: 98 participants

Conditions and interventions

Conditions

Cholangiocarcinoma

Interventions

GNS561 + Trametinib Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 20, 2023
Primary completion: Nov 30, 2027
Completion: May 31, 2028
Last update posted: Jul 12, 2026

2023 – 2028

United States locations

U.S. sites: 10
U.S. states: 8
U.S. cities: 9

Facility	City	State	ZIP	Site status
USC Norris Comprehensive Cancer Center	Los Angeles	California	90033	Recruiting
LACN Aneheim Flagship Office	Los Angeles	California	92805	Recruiting
Orlando Health	Orlando	Florida	32806	Recruiting
Moffitt Cancer Center	Tampa	Florida	33612	Recruiting
University Of Chicago Medical Center	Chicago	Illinois	60637	Recruiting
Roswell Park Cancer Institute	Buffalo	New York	14263	Terminated
Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	19104	Terminated
University of Texas, MD Anderson Cancer Center	Houston	Texas	77030	Recruiting
University of Virginia Comprehensive Cancer Center	Charlottesville	Virginia	22908	Recruiting
Froedtert Hospital and the Medical College of Wisconsin	Milwaukee	Wisconsin	53226	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05874414, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 12, 2026 · Synced Sep 20, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05874414 live on ClinicalTrials.gov.

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