Study on Combining GNS561 and Trametinib for Patients with Advanced KRAS Mutation Cholangiocarcinoma

Inclusion Criteria

• Diagnosed with cholangiocarcinoma (bile duct cancer) that has a KRAS mutation.
• Aged 18 years or older.
• Cancer has progressed and cannot be cured with current treatments.
• Have received at least one previous chemotherapy treatment.
• Have at least one tumor that can be measured by scans.
• In good general health, with a performance status score of 0 or 1.
• Have adequate organ function based on specific blood tests.
• Women of childbearing age must have a negative pregnancy test and agree to use contraception during the study and for 6 months after.
• Men with partners of childbearing age must agree to use contraception.
• Able to understand and willing to follow the study requirements.
• Willing to sign a consent form to participate.

Exclusion Criteria

• Have previously been treated with a MEK inhibitor or autophagy inhibitor.
• Have uncontrolled or significant health issues, such as:
  • Heart problems, including heart failure or recent heart attack.
  • Eye conditions affecting the retina.
  • Lung diseases like interstitial lung disease or pneumonitis.
  • Significant fluid buildup in the chest or abdomen.
  • Neurological issues like seizures or brain metastases.
  • Digestive problems that could affect drug absorption.
• Currently taking cancer drugs for another type of cancer, unless cancer-free for 3 years.
• Have significant liver disease or active viral infections like hepatitis B or C.
• Allergic to quinoline derivatives or study drugs.
• Women who are pregnant or breastfeeding.