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NCT05874414 | RECRUITING | Cholangiocarcinoma

Combination of GNS561 and Trametinib in Patients with Advanced KRAS Mutated Cholangiocarcinoma
Sponsor:

Genfit

Brief 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

Condition or disease

Cholangiocarcinoma

Intervention/treatment

GNS561 + Trametinib

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 74 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Phase 1b/2a Study of GNS561 in Combination with Trametinib in Advanced KRAS Mutated Cholangiocarcinoma
Actual Study Start Date : 2023-08-21
Estimated Primary Completion Date : 2026-05
Estimated Study Completion Date : 2026-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion criteria
  • 1. Histologically confirmed CCA with a documented KRAS mutation.
  • 2. Patients greater than or equal to 18 years of age.
  • 3. Patients must have disease progression that is not amenable to potentially curative treatment.
  • 4. Patients must have received at least one line of chemotherapy.
  • 5. Patients must have at least one measurable disease by RECIST v1.1.
  • 6. Performance status (ECOG) 0-1.
  • 7. 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 equal to 3 × upper limit of normal, estimated glomerular filtration rate ≥60 mL/min, corrected QT interval by Fridericia's (QTcF) interval ≤470 msec.
  • 8. 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 of childbearing potential must agree with the contraception procedures of the study protocol.
  • 9. Patients must be able to understand and be willing to comply with the requirements of the study protocol.
  • 10. Patients participate voluntarily and sign informed consent form(s).
  • Exclusion criteria
    • 1. Previous treatment with a MEK inhibitor or autophagy inhibitor.
    • 2. Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions
      • 1. Cardiovascular disorders: congestive heart failure New York Heart Association ≥ class 2 or left ventricular ejection fraction (LVEF) \<50%, arrythmias or cardiac conduction abnormalities. Uncontrolled arterial hypertension or inadequately controlled arterial hypertension, at the discretion of the investigator, based on an average of = \>3 BP readings over = \>2 sessions.
      • 2. Patients who have retinal condition (retinal tear, exudate, hemorrhage) or history of retinal vein occlusion or central serous retinopathy or retinal pigment epithelial detachment.
      • 3. History of interstitial lung disease or pneumonitis.
      • 4. Patients who have clinically significant pleural effusion or ascites.
      • 5. Patients who have neurological condition (e.g., tremor, ataxia, hypotension, confusion), history of seizures or active central nervous system metastases.
      • 6. 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 the principal investigator (PI) may impair absorption of study drugs).
      • 7. 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 death (e.g., 5-year OS rate \> 90%) such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
      • 8. 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, unable to swallow medication, social/psychological issues, etc).
      • 3. Known active viral hepatitis, including HBV and HCV.
      • 4. Patients with known allergic reaction to quinoline derivatives (e.g., quinine, chloroquine, mefloquine) and/or hypersensitivity to study drugs.
      • 5. Female patients who are pregnant or lactating at the time of enrollment.
Combination of GNS561 and Trametinib in Patients with Advanced KRAS Mutated Cholangiocarcinoma

Location Details

NCT05874414

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

RECRUITING

United States, Illinois

University Of Chicago Medical Center

Chicago, Illinois, United States, 60637

RECRUITING

United States, New York

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

WITHDRAWN

United States, Pennsylvania

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

RECRUITING

United States, Texas

University of Texas, MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Virginia

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia, United States, 22908

RECRUITING

United States, Wisconsin

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

RECRUITING

Puerto Rico,

Pan American Center for Oncology Trials, LLC

Rio Piedras, Puerto Rico, 00935