A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of Gastrointestinal Adenocarcinoma

Inclusion Criteria:

• Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Subjects with tumors specified below, who are at high risk of relapse, have beentreated with curative intent, and have no evidence of disease (NED) followingfront-line therapy with surgery, radiation therapy, and/or chemotherapy. NEDincludes, where applicable, surgical (macroscopic tumor margin, at the time ofsurgery), and radiological evidence of disease. Residual lesions identified bymicroscopic/frozen margins and biochemical markers are permitted. Therapy must havebeen completed no fewer than four weeks, and no later than 25 weeks, before thefirst dose of Ad5.F35-hGCC-PADRE

• For tumor-specific criteria, please refer to the information below:

• Pancreatic ductal adenocarcinoma

** Stage I, II, III

• Neuroendocrine tumors of the pancreas are not permitted

• Colorectal adenocarcinoma

• Stage III; stage IV following metastasectomy

• Gastric adenocarcinoma

• Stage IIA, IIB, III

• Gastrointestinal stromal tumors of the stomach are not permitted

• Esophageal adenocarcinoma ** Stage IIB, III

• Esophageal squamous cell carcinomas are not permitted

• Have an anticipated life expectancy of greater than 12 weeks

• Absolute neutrophil count (ANC) >= 1000 cells/mL

• Platelets >= 75,000 /mL

• Hemoglobin >= 9.0 g/dL

• Serum creatinine < 2.0 mg/dL

• For other blood and urine tests including blood chemistry, hepatic and renalfunctions, test results should not be worse than grade 1 levels of abnormalitiesdefined by Common Terminology Criteria for Adverse Events (CTCAE), National CancerInstitute (NCI) version 5 issued by the United States (US) Department of Health andHuman Services

• For women and men of childbearing potential, a medically acceptable method of highlyeffective contraception (oral hormonal contraceptive, condom plus spermicide, orhormonal implants) or abstinence must be used throughout the study period and for 28days after their final vaccine administration (a barrier method of contraceptionmust be employed by all subjects [male and female], regardless of other methodsunless abstinent). A negative serum or urine pregnancy test is required as part ofscreening. Women of childbearing potential is defined as any female who hasexperienced menarche and who has not undergone surgical sterilization (hysterectomyor bilateral oophorectomy) or who is not postmenopausal. Menopause is definedclinically as 12 months of amenorrhea in a woman over 45 in the absence of otherbiological or physiological causes. In addition, women under the age of 55 must havea documented serum follicle stimulating hormone (FSH) level less than 40 mIU/ml

• Be willing to comply with all the study procedures

• All subjects must be able to comprehend and sign a written informed consent document

Exclusion Criteria:

• Have a known history or evidence of residual disease after definitive surgery

• Have a known metastasis in the brain or central nervous system

• Prior receipt of immunotherapy or experimental medications after completion ofstandard adjuvant therapy

• Have a history of splenectomy

• Have a history of distal pancreatectomy

• Concurrent use of systemic steroids or immunosuppressive drugs (use of topical orinhaled steroids will be allowed)

• Have any immunodeficiency disease or immunocompromised state (e.g., use ofimmunosuppressive agents, chemotherapy or radiation therapy within four weeks ofstudy treatment)

• Have active autoimmune disease or history of autoimmune disease or a transplantrecipient requiring systemic steroids or other immunosuppressive treatment

• Have received a diagnosis of human immunodeficiency virus (HIV), hepatitis B, orhepatitis C (subjects who are hepatitis C positive may be enrolled if they areconfirmed with negative viral load at screening)

• Other malignancy within last 5 years except curatively treated non-melanomatous skincancer and curatively treated carcinoma in situ of the uterine cervix, orearly-stage (stage A or B1) prostate cancer

• Have a history of inflammatory bowel disease

• Have a history of serious reaction to adenovirus

• Have an intercurrent illness that is either life-threatening or of clinicalimportance such that it might limit study compliance (such illnesses include, butare not limited to, ongoing or active infection, metabolic or neurologic disease,peripheral vascular disease, or psychiatric illness)

• Have insufficient peripheral venous access to permit completion of the studyphlebotomy regimen

• Consumes greater than three glasses of alcoholic beverages (1 glass is approximatelyequivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce]) per day and cannot refrain from alcohol for the duration of thetrial

• Has a history of use of illicit drugs (e.g., opioids, cocaine, amphetamines,hallucinogens, etc.) that could potentially interfere with adherence to studyprocedures or requirements

• Be a woman who is pregnant or breastfeeding

• Have an unhealed surgical wound

• Have had major surgery or significant traumatic injury occurring within 28 daysbefore treatment or anticipated surgery or procedure requiring general anesthesiaduring the study participation (including four weeks after last dose of vaccine)