Expanded Access of Vigil in Solid Tumors

Study Enrollment Inclusion Criteria:

1. Histologically confirmed advanced or metastatic non-curable solid tumor.

2. Completed manufacture of at least 1 vial of Vigil, but failure of one or moremanufacturing release criteria.

3. ECOG performance status (PS) 0-1 or Karnofsky performance status (KPS) / Lanskyperformance status (LS)≥ 70%.

4. Normal organ and marrow function as defined below: Absolute granulocyte count ≥1,000/mm3, Absolute lymphocyte count ≥400/mm3, Platelets ≥75,000/mm3, Hemoglobin ≥ 8.0 mg/dL, Total bilirubin ≤ institutional upper limit ofnormal*, AST(SGOT)/ALT(SGPT) ≤2x institutional upper limit of normal, Creatinine <1.5 mg/dL

*documented Gilbert's syndrome may be considered after medical monitor review

5. No systemic therapy, immunologic therapy or investigational therapy within 2 weeksand no radiation therapy within 1 week prior to enrollment.

6. Subject has recovered to CTCAE Grade 1 (except for parameters noted in Item 4,above) or better from all adverse events associated with prior therapy or surgery.Pre-existing motor, sensory neurologic pathology or symptoms, or dermatologictoxicities must be recovered to CTCAE Grade 2 or better.

7. If female of childbearing potential, has a negative urine or serum pregnancy test.If the urine test is positive or cannot be confirmed as negative, a negative serumtest will be required for study entry.

8. Ability to understand and the willingness to sign a written informed protocolspecific consent or a parental/guardian informed consent and pediatric assent whenappropriate.

Study Enrollment Exclusion Criteria:

1. Medical condition requiring any form of chronic systemic immunosuppressive therapy (steroid or other) except physiologic replacement doses of hydrocortisone orequivalent (no more than 30 mg hydrocortisone or 10 mg prednisone equivalent daily)for < 30 days duration.

2. Known history of other malignancy unless having undergone curative intent therapywithout evidence of that disease for ≥ 3 years except cutaneous squamous cell andbasal cell skin cancer, superficial bladder cancer, in situ cervical cancer or otherin situ cancers are allowed if definitively resected.

3. Receipt of greater than 2 lines of systemic treatment between Vigil manufacture andscreening for this protocol.

4. Live vaccine used for the prevention of infectious disease administered < 30 daysprior to the start of study therapy.

5. Post-surgery complication that in the opinion of the treating investigator wouldinterfere with the subject's study participation or make it not in the best interestof the patient to participate.

6. Brain metastases unless treated with curative intent (gamma knife or surgicalresection) and without evidence of progression for ≥ 2 months.

7. Any documented history of autoimmune disease with exception of Type 1 diabetes onstable insulin regimen, hypothyroidism on stable dose of replacement thyroidmedication, vitiligo, or asthma not requiring systemic steroids.

8. Known HIV or chronic Hepatitis B or C infection.

9. Known history of allergies or sensitivities to gentamicin.

10. History of or current evidence of any condition (including medical, psychiatric orsubstance abuse disorder), therapy, or laboratory abnormality that might confoundthe results of the study, interfere with the patient's participation for the fullduration of the study, or is not in the best interest of the patient to participate,in the opinion of the treating Investigator.