Study on First-In-Human Use of STX-241 for Advanced or Metastatic Lung Cancer Resistant to EGFR Treatments

Inclusion Criteria

• Must be 18 years or older and have signed a consent form to participate.
• Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations.
• Cancer must have progressed after treatment with a third-generation EGFR TKI, like osimertinib.
• Have a specific tumor mutation profile, including the presence of C797X mutation and absence of T790M mutation.
• Have at least one measurable tumor.
• Be in good overall health with an ECOG performance status of 0 or 1.
• Have adequate organ function, including specific blood counts and liver and kidney function.
• Have adequate heart function, including normal heart rhythm and blood pressure.
• Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for a specified period after.
• Men must agree to use contraception and not donate sperm during the study and for a specified period after.

Exclusion Criteria

• Eligible for other targeted therapies based on local testing.
• Have rapidly progressing disease that requires immediate chemotherapy.
• Unable to swallow or digest tablets due to certain medical conditions.
• Have a history of another primary cancer, with some exceptions.
• Have spinal cord compression or brain metastases with worsening symptoms.
• Have allergies to the study drug or similar drugs.
• Have active infections, including hepatitis B, hepatitis C, or HIV, unless controlled.
• Have a positive COVID-19 test or suspected infection.
• Have significant heart problems or other serious medical conditions.
• Have a history of lung diseases like interstitial lung disease or radiation pneumonitis.
• Have a history of severe skin reactions like Stevens-Johnson Syndrome.
• Women who are breastfeeding.
• Have received certain cancer treatments or vaccines within a specified time before the study.
• Have unresolved side effects from previous treatments.
• Have had major surgery recently.
• Are taking certain medications that interact with the study drug.
• Are participating in another clinical trial or have recently taken an investigational drug.
• Have any condition that the investigator believes would not be in the participant's best interest to join the study.
• Are an employee or family member of the study staff.