Expanded Access to Neoantigen Synthetic Long Peptide Vaccines for Patients with Local or Metastatic Solid Tumors

Inclusion Criteria

• Must be 12 years or older.
• Must be in relatively good health, with a performance status score of 2 or lower, or a Karnofsky score of 70 or higher.
• Must have good organ function, as determined by the treating doctor.
• Can take low-dose steroid medication (up to 4 mg of dexamethasone or equivalent) on the day of the vaccine.
• Must be able to understand and willing to sign a consent form approved by the Institutional Review Board (IRB).

Exclusion Criteria

• History of severe allergic reactions to vaccines, such as anaphylaxis, hives, or breathing difficulties, or known allergy to any component of the vaccine.
• Ongoing illness requiring medications that could interfere with emergency treatments for vaccine-related allergic reactions or weaken the immune response to the vaccine.
• Mental health or social issues that would make it difficult to follow the study requirements.
• Pre-existing immune system disorders or autoimmune conditions requiring immunosuppressive therapy that would prevent a response to the vaccine.
• Women who can become pregnant must agree to abstain from sex or use two highly effective birth control methods during the study and for three months after the last dose, and must have a negative pregnancy test.
• Women who cannot become pregnant must be post-menopausal or have had surgery to prevent pregnancy.
• Men with partners who can become pregnant must agree to abstain from sex or use a doctor-approved birth control method during the study and for three months after the last dose.