New drug duo targets hard-to-treat bile duct cancer

NCT ID NCT05874414

Recruiting now Disease control Sponsor: Genfit Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This study tests a combination of two drugs, GNS561 and trametinib, in people with advanced bile duct cancer that has a specific genetic change (KRAS mutation) and has not responded to standard first-line therapy. The trial has two phases: first to find the safest dose, then to see if the combination shrinks tumors. About 74 adults will take part across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: GNS561 (ezurpimtrostat) and trametinib
What this could lead to: If successful, this combination could offer a new treatment option for people with advanced bile duct cancer that has a KRAS mutation and has stopped responding to standard chemotherapy.
What could go wrong: This is an early-phase trial with only 74 participants, so the drug combination may not prove effective or safe enough for wider use. Side effects could be serious, and the cancer may still progress.

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Conditions

The condition(s) this trial relates to.

bile duct neoplasm cholangiocarcinoma intrahepatic cholangiocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CHOLANGIOCARCINOMA

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••

Locations

Froedtert Hospital and the Medical College of Wisconsin
RECRUITING

Milwaukee, Wisconsin, 53226, United States
Hospital of the University of Pennsylvania
TERMINATED

Philadelphia, Pennsylvania, 19104, United States
LACN Aneheim Flagship Office
RECRUITING

Los Angeles, California, 92805, United States
Moffitt Cancer Center
RECRUITING

Tampa, Florida, 33612, United States
Orlando Health
RECRUITING

Orlando, Florida, 32806, United States
Pan American Center for Oncology Trials, LLC
RECRUITING

Rio Piedras, Puerto Rico, 00935, Puerto Rico
Roswell Park Cancer Institute
TERMINATED

Buffalo, New York, 14263, United States
USC Norris Comprehensive Cancer Center
RECRUITING

Los Angeles, California, 90033, United States
University Of Chicago Medical Center
RECRUITING

Chicago, Illinois, 60637, United States
University of Texas, MD Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States
University of Virginia Comprehensive Cancer Center
RECRUITING

Charlottesville, Virginia, 22908, United States

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