Expanded Access Neoantigen Vaccine in Solid Tumors

Study Overview
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Brief Summary
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This is an expanded access use study. Safety data will be collected from participants.

Official Title
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Expanded Access Neoantigen Vaccine in Solid Tumors

Conditions
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Solid Tumor, Adult

Intervention / Treatment
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* Biological: Neoantigen DNA Vaccine
* Device: Integrated electroporation device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Neoantigen DNA Vaccine|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.|
|Device: Integrated electroporation device|Ichor Medical Systems All study injections will be given intramuscularly using an integrated electroporation device|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |