Expanded Access To Neoantigen Synthetic Long Peptide Vaccines in Patients With Local Or Metastatic Solid Tumors

Expanded Access To Neoantigen Synthetic Long Peptide Vaccines in Patients With Local Or Metastatic Solid Tumors

This is an intermediate patient expanded access protocol for treatment of patients with local or metastatic solid tumors with a neoantigen synthetic long peptide vaccine.

Patients must satisfy the following criteria to be enrolled in the protocol:

Main Inclusion Criterion:

1. Patient who qualifies for treatment under 21 CFR 312.305 based on treating physician judgment, inability to enroll in study JLF-200, must have received or be ineligible for FDA-approved therapies for their specific cancer type, and an estimated 5-year survival of less than 50%.

Other Inclusion Criteria:

1. >= 12 years of age.
2. ECOG performance status ≤ 2 or Karnofsky score of >=70.
3. Adequate organ function allowing favorable benefit to risk ratio per the treating physician
4. Systemic corticosteroid therapy is permitted provided dosing is no greater than 4 mg per day (dexamethasone or equivalent) on the day of vaccine administration.
5. Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

1. History of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty or known allergy to a component of the neoantigen synthetic long peptide vaccine.
2. Intercurrent illness requiring chronic use of medications that may interfere with rescue medications for treatment of vaccine-related anaphylaxis or attenuate immune response to vaccine treatment (immunosuppressive therapies).
3. Psychiatric illness or social situations that would limit compliance with study requirements.
4. History of pre-existing immunodeficiency disorder or autoimmune condition requiring immunosuppressive therapy that would preclude response to vaccine. 5. Females of childbearing potential may participate provided they agree to practice abstinence; and, if heterosexually active, agree to use at least 2 highly effective contraceptive methods throughout the study and for 3 months following the last dose of study drug; and have a negative serum pregnancy test.

6. Females of non-childbearing potential must be post-menopausal or have been surgically sterilized.

7. Male subjects with a female partner of childbearing potential must agree to practice abstinence or to use a physician-approved contraceptive method throughout the study and for 3 months following the last dose of study drug.