Phase II Study of Enfortumab Vedotin for Patients with Advanced Colorectal or Liver Cancer

Inclusion Criteria

• Have advanced colorectal cancer (CRC) or liver cancer (HCC) that has spread or cannot be removed by surgery.
• Have tried at least two previous treatments for CRC or one for HCC, but no more than three for CRC or two for HCC.
• Have measurable cancer that can be tracked using standard criteria.
• Be 18 years or older.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have adequate blood cell counts and organ function, including:
  • Neutrophil count of at least 1500/mm3.
  • Platelet count of at least 100,000/mm3.
  • Hemoglobin level of at least 9 g/dL.
  • Normal liver and kidney function as indicated by specific blood tests.
• Provide a tumor tissue sample before starting treatment.
• Have a life expectancy of at least 3 months.
• Agree to use effective contraception during the study and for 4 months after the last dose.
• Understand the study and agree to sign informed consent.

Exclusion Criteria

• Have received radiation, major surgery, or other cancer treatments within 2 weeks before starting the study drug.
• Have ongoing nerve damage or other significant side effects from previous treatments.
• Have active cancer that has spread to the brain or spinal cord, unless stable and treated.
• Have previously participated in an enfortumab vedotin study or received similar treatments.
• Have another active cancer within the past 3 years, except for certain non-threatening cancers.
• Have an active infection requiring treatment.
• Have active hepatitis B or C, or HIV infection, unless well-controlled.
• Have had a recent stroke, heart attack, or severe heart problems.
• Have an allergy to enfortumab vedotin or its ingredients.
• Have active eye infections or uncontrolled diabetes.
• Have uncontrolled pain or other serious health conditions that would interfere with the study.
• Be pregnant or breastfeeding, as the study drug may harm the baby.