Actively Recruiting
Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma
Led by Genfit · Updated on 2026-05-14
74
Participants Needed
11
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed intrahepatic cholangiocarcinoma with documented KRAS mutation
- Age 18 years or older
- Disease progression not suitable for curative treatment
- Received one or two lines of chemotherapy
- At least one measurable tumor by RECIST v1.1
- Performance status ECOG 0-1
- Adequate organ function including neutrophils 1000 cells/bcL, platelets 75,000 cells/bcL, hemoglobin 9 g/dL, liver enzymes 3 times upper limit of normal, kidney function 60 mL/min, QTcF 470 msec
- Negative pregnancy test for women of childbearing potential and agreement to use contraception
- Ability to understand and comply with study protocol
- Voluntary participation with informed consent
You will not qualify if you...
- Previous treatment with MEK inhibitor or autophagy inhibitor
- More than two prior chemotherapy treatments
- Extrahepatic cholangiocarcinoma
- Uncontrolled significant illness including heart failure NYHA class 2, LVEF <50%, arrhythmias, uncontrolled hypertension
- Retinal disorders or history of retinal vein occlusion or central serous retinopathy
- History of interstitial lung disease or pneumonitis
- Significant pleural effusion or ascites
- Neurological disorders such as tremor, ataxia, seizures, or brain metastases
- Gastrointestinal diseases affecting drug absorption
- Current or recent other cancers except certain low-risk types
- Any condition impacting safety or compliance as judged by investigator
- Active hepatitis B or C infection
- Allergy to quinoline derivatives or study drugs
- Unresolved side effects from previous treatments
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
2
LACN Aneheim Flagship Office
Los Angeles, California, United States, 92805
Actively Recruiting
3
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
5
University Of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
6
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Terminated
7
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Terminated
8
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
9
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
10
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
11
Pan American Center for Oncology Trials, LLC
Rio Piedras, Puerto Rico, Puerto Rico, 00935
Actively Recruiting
Research Team
P
Pejvack MOTLAGH, CMO
CONTACT
P
Pejvack MOTLAGH, CMO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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