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New treatment option for Cholangiocarcinoma
Official title Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma
ClinicalTrials.gov ID: NCT05874414
What this study is testing
What is GNS561 + Trametinib?
GNS561 + Trametinib is an investigational medicine, being studied as a potential treatment for cholangiocarcinoma.
Also referred to as Ezurpimtrostat (GNS561).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed intrahepatic CCA with a documented KRAS mutation.
- Patients greater than or equal to 18 years of age.
- Patients must have disease progression that is not amenable to potentially curative treatment.
- Patients must have received one or two lines of chemotherapy.
- Patients must have at least one measurable disease by RECIST v1.1.
You likely can't join if
- Previous treatment with a MEK inhibitor or autophagy inhibitor.
- Previous treatment with three or more lines of prior chemotherapy.
- Extrahepatic CCA with recent (within 6 weeks) placement of a stent or episodes of unstable biliary stents (manifest as obstruction, migration of the...
- Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
- Cardiovascular disorders: congestive heart failure New York Heart Association ≥ class 2 or left ventricular ejection fraction (LVEF) \ 3 BP readings...
- Patients who have retinal condition (retinal tear, exudate, hemorrhage) or history of retinal vein occlusion or central serous retinopathy or retinal...
See the full eligibility criteria
- Histologically confirmed intrahepatic CCA with a documented KRAS mutation.
- Patients greater than or equal to 18 years of age.
- Patients must have disease progression that is not amenable to potentially curative treatment.
- Patients must have received one or two lines of chemotherapy.
- Patients must have at least one measurable disease by RECIST v1.1.
- Performance status (ECOG) 0-1.
- Adequate organ baseline function defined as follows: absolute neutrophil count ≥1000 cells/μL, platelet count ≥75,000 cells/μL, hemoglobin ≥9 g/dL, aspartate aminotransferase or alanine aminotransferase less than or...
- Women of childbearing potential must present with a negative serum pregnancy test and agree to use adequate contraception during the study and until 6 months after the end of treatment. Male patients with women partners...
- Patients must be able to understand and be willing to comply with the requirements of the study protocol.
- Patients participate voluntarily and sign informed consent form(s).
- Previous treatment with a MEK inhibitor or autophagy inhibitor.
- Previous treatment with three or more lines of prior chemotherapy.
- Extrahepatic CCA with recent (within 6 weeks) placement of a stent or episodes of unstable biliary stents (manifest as obstruction, migration of the stent, infevtion or mechanical failure of the stent) within 6 weeks...
- Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
- Cardiovascular disorders: congestive heart failure New York Heart Association ≥ class 2 or left ventricular ejection fraction (LVEF) \ 3 BP readings over = \>2 sessions.
- Patients who have retinal condition (retinal tear, exudate, hemorrhage) or history of retinal vein occlusion or central serous retinopathy or retinal pigment epithelial detachment.
- History of interstitial lung disease or pneumonitis.
- Patients who have clinically significant pleural effusion or ascites.
- Patients who have neurological condition (e.g., tremor, ataxia, hypotension, confusion), history of seizures or active central nervous system metastases.
- Impairment of gastrointestinal function or gastrointestinal disease (e.g., diarrhea, active ulcer disease, history of gastrointestinal perforation/hemorrhage, malabsorption or other conditions that under the judgment of...
- Patients who are taking antineoplastic drugs for concomitant cancer or history of malignancy other than CCA within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or...
- Any other condition that would, in the Investigator s judgment, contraindicate the patients' participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection...
- Known active viral hepatitis, including HBV and HCV.
- Patients with known allergic reaction to quinoline derivatives (e.g., quinine, chloroquine, mefloquine) and/or hypersensitivity to study drugs.
- Patients who have not recovered for certain AEs due to previous lines of therpay.
- Female patients who are pregnant or lactating at the time of enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Buffalo, New York, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
- Milwaukee, Wisconsin, United States
- Rio Piedras, Puerto Rico, Puerto Rico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Orlando, Florida, United States; Tampa, Florida, United States; Chicago, Illinois, United States; Buffalo, New York, United States; Philadelphia, Pennsylvania, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.