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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: Recruiting Phase 1 study of Cholangiocarcinoma, sponsored by Genfit.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Defined as Treatment Emergent Adverse Event (TEAE) being at least possibly related to study drug: With Grade ≥ 3 (using NCI CTCAE Version 5.0 or higher as applicable) such as specified in the protocol
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 |
What NCT05874414 shows while recruiting
NCT05874414 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 385-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (81% lower).
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 lists 11 locations in 9 states (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.
Where NCT05874414's enrollment target sits among peer trials
74 34th of 60 higher than 27 of 60 other Cholangiocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cholangiocarcinoma 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.
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