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

Inclusion Criteria:

Prior to vaccine production -

1. Diagnosis of advanced cancer (solid tumor) that:

1. May be receiving or about to start another line of therapy.

2. If on a line of therapy or about to start a new line of therapy, it is
anticipated that the treatment may provide short-term tumor control.

2. Available tissue from an archival tissue sample or tissue from a biopsy done during
the initial screen, or both. If archival tissue is not available or tissue is not
mainly tumor, subjects must be willing to undergo a biopsy or surgery to remove some
or all of their tumor for next generation sequencing. New tissue should be obtained
prior to starting a new line of therapy, if applicable.

3. Minimum estimated life expectancy of 6 months.

4. Age 18 years or older.

5. Signed written informed consent to allow transfer of tumor tissue and production of
vaccine.

6. Discussion about each patient should occur with the Medical Monitor to confirm
eligibility.

Prior to Treatment -

Patients who had vaccine manufactured but were treated with an additional line of treatment
may start vaccine if they continue to meet the remaining eligibility criteria.:

1. Diagnosis of advanced cancer (solid tumor) that is refractory to standard therapies.

2. Signed written informed consent for treatment.

3. Minimum estimated life expectancy of 3 months.

4. Eastern Cooperative Oncology Group (ECOG) performance status <2.

5. Adequate bone marrow function (absolute neutrophil count [ANC] ≥1,500/mm^3; absolute
lymphocyte count [ALC] ≥500/mm^3; platelet count 100,000/mm^3), adequate liver
function (serum glutamic oxaloacetic transaminase [SGOT]/aspartate aminotransferase
[AST] and alkaline phosphatase <2.5 times the institutional upper limit of normal
[IULN], total bilirubin <1.5 mg/dL), and adequate renal function (creatinine <1.5 x
IULN).

6. Adequate cardiac function (New York Heart Association [NYHA] class ≤II).

7. All participants (males and females) must agree to use adequate contraception
(hormonal or barrier method of birth control, abstinence) prior to study treatment and
for the duration of study participation.

Female subjects of childbearing potential should have a negative serum pregnancy test at
pre-treatment visit and within 72 hours prior to receiving the first dose of study
medication.

Female subjects of childbearing potential must agree to use 2 methods of birth control or
be surgically sterile, or abstain from heterosexual activity prior to receiving the first
dose of study medication through 30 days after the last dose of study medication.

Exclusion Criteria:

Subjects must not meet any of the following exclusion criteria at the time of tumor
procurement. All exclusion criteria must be confirmed prior to treatment.

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.

Prior to Treatment - Subjects must not meet any of the following exclusion criteria prior
to treatment in addition to the other exclusion criteria listed above.

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.