Safety and Tolerability Study of AutoSynVax™ Vaccine in Subjects With Advanced Cancer

Exclusion Criteria

• •1. Diagnosis of immunodeficiency or actively receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
• •2. Corticosteroid dependency.
• •3. Requirement for immunosuppressive medication aside from corticosteroids.
• •4. Active or history of any autoimmune disease (subjects with diabetes type 1, vitiligo, psoriasis, hypo-, or hyperthyroid disease not requiring immunosuppressive treatment are eligible) or immunodeficiencies.
• •5. History of treated or untreated brain metastases or leptomeningeal spread of disease.
• •6. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• •7. Known medical, psychiatric or substance abuse disorders that would preclude participation in the study.
• •8. Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• •9. Known to be positive for human immunodeficiency virus (HIV). Testing is not required in the absence of history or high index of suspicion.
• •10. Intolerance of prior immunotherapy treatment necessitating cessation of therapy.
• •11. History of intolerance or allergic reactions attributed to compounds of similar chemical or biologic composition to AutoSynVax™ vaccine or QS-21.
• •12. Women who are pregnant or breastfeeding.
• •13. Inability to comply with protocol.
• •1. Receipt of anticancer medications or investigational drugs within the following intervals before first administration of study drug:
• •1. ≤14 days for chemotherapy, targeted small molecule therapy, anticancer hormone therapy or radiation therapy. Subjects must also not have had radiation pneumonitis as a result of treatment, and cannot participate in the study if they are on chronic corticosteroids for radiation pneumonitis or other reasons. A 1-week washout is permitted for palliative radiation to non-CNS disease with sponsor approval.
• •2. Note: Bisphosphonates and denosumab are permitted medications. Novel imaging agents that have Phase 1 safety data and have not demonstrated therapeutic activity are also permitted.
• •3. ≤28 days for a prior immunotherapy.
• •4. ≤28 days for prior monoclonal antibody used for anticancer therapy with the exception of denosumab.
• •5. ≤7 days for immunosuppressive-based treatment for any reason. Systemic corticosteroids are not allowed.
• •Note: Use of inhaled or topical corticosteroid use for radiographic procedures is permitted.
• •Note: Patients receiving physiologic steroid replacement for adrenal insufficiency are eligible (i.e. \< 10 mg prednisone per day).
• •Note: The use of physiologic corticosteroid replacement therapy may be approved after consultation with the sponsor.
• •6. ≤28 days before the first dose for all other investigational study drugs or devices.
• •2. Receipt of other investigational agents or other anticancer therapies during treatment with AutoSynVax™ vaccine.
• •3. Receipt of a live vaccine within 30 days prior to the first dose of trial treatment.