Expanded Access Neoantigen Vaccine in Solid Tumors

• Neoantigen DNA Vaccine (Biological): The schedule for vaccination will be weeks 1, 5, 9, 13, 17, and 21. All vaccines will occur within +/- 1 week with at least 3 weeks between vaccines.
• Integrated electroporation device (Device), also known as TDS-IM System: * Ichor Medical Systems * All study injections will be given intramuscularly using an integrated electroporation device

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of a solid tumor
* Pathology review demonstrates tumor cellularity of >30% in quantities sufficient to complete DNA and RNA library construction
* At least 18 years of age.
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Able to understand and willing to sign an IRB approved written informed consent document.

Exclusion Criteria:

* Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty.
* Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, hepatic renal, and/or other functional abnormality that would jeopardize the health and safety of the participant as determined by the investigator based on medical history, physical examination, laboratory values, and/or diagnostic studies.
* History of syncopal or vasovagal episode as determined by medical record and history in the 12 month period prior to first vaccination administration.
* Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for eligible injection sites (left and right medial deltoid region) exceeds 40 mm.
* Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art.
* Therapeutic or traumatic metal implant in the skin or muscle of either deltoid region.
* Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.
* Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.
* Pregnant and/or breastfeeding.

• William E Gillanders, M.D., Principal investigator, Washington University School of Medicine