This research study is for individuals who have advanced breast, colon, pancreatic, ovarian or bladder cancer.

Celldex Therapeutics, Inc. is testing CDX-1307, an investigational drug that is being tested to see if it can stimulate the immune system of people with certain kinds of cancer.

It is believed that the body's immune system can attack tumor cells and kill them. It is thought that immune cells recognize special proteins on the surface of tumors as a signal to fight the cancer.

One of these proteins is called human chorionic gonadotropin-beta (hCG-β) and is found on several types of cancers including breast, colorectal, pancreatic, bladder and ovarian.

The study drug will be given as an injection under the skin (an intradermal or intracutaneous injection). In addition, the study includes combination with TLR agonists, which are thought to stimulate the immune response against tumor cells.

Eligibility

Inclusion Criteria

To participate in this study, you must be at least 18 years of age or older and have:

• Read read, understood, and provided written informed consent and HIPAA authorization after the nature of the study has been fully explained
• Incurable breast, colorectal, pancreatic, ovarian or bladder cancer with measurable or evaluable disease
• Never received prior hCG-β therapy. 
• Received therapy with potential survival benefit or disease-specific palliation, but experienced recurrence or progression while on that therapy/palliation (if no such therapy is available, patients with progressive disease may be enrolled).
• Not refuse standard of care options known to provide potential survival benefit or disease specific palliation
• Allowed four weeks to pass between prior therapy and first dose of the vaccine
• No prior radiopharmaceuticals within eight weeks prior to the first vaccine dose
• Recovered from any clinically significant toxicity experienced during prior treatment(s).
• Begun treatments with the following drugs four weeks before the study and if no dosing changes are anticipated during the study:hormonal therapy including gonadotropin releasing hormone (GnRh) agonist, antiandrogens, selective estrogen receptor modulators (SERMs), aromatase inhibitors, progestins, and bisphosphonates. 
• An ECOG status of zero or one.
• A life expectancy greater than or equal to 16 weeks.
• Willingness to practice an effective form of barrier contraception during the course of the study (for sexually active male patients) 
• Screening laboratory values that meet the following criteria:
  Neutrophils ≥1.5 x109/L
  Platelets >100 x109/L
  Hemoglobin <10 g/dL
  Creatinine <2 mg/dL
  AST <2 X ULN
  Bilirubin <2 X ULN unless due to Gilbert's syndrome upper limit of normal. Laboratory abnormalities attributed to liver involvement with cancer but outside of the normal range will be allowed if they do not exceed the following limits:
  AST <4 X ULN
  Bilirubin <4 X ULN

Exclusion Criteria

Exclusion criteria for this study includes:

• Since treatment with CDX-1307 theoretically may cause permanent sterility, women of childbearing potential will be excluded (women who participate in this study must be post-menopausal [absence of menses for at least one year] or surgically incapable of bearing children).
• Previous administration of hCG-β vaccine or therapy.
• Concurrent treatment with immunosuppressive or immunomodulatory agents.
• Positive tests for HIV, HBV or HCV.
• Patients with an active systemic infection requiring antibiotic treatment or a fever over 100°F within 72 hours prior to enrollment.
• Generalized dermatologic conditions (such as allergic reactions, infection, edema, or scarring) that will not allow easy access for study drug administration or evaluation of localized adverse events.
• Patients with active central nervous system metastases, unless previously treated and asymptomatic for two months and not progressive in size or number for two months.
• History of a second malignancy, except for adequately treated and cured basal or squamous cell skin cancer or any other cancer from which the patient has been disease-free for at least five years.
• History of anaphylactic reaction following exposure to humanized or human therapeutic monoclonal antibodies, or known hypersensitivity to GM-CSF, or yeast derived products.
• Patients with any of the following conditions: myocardial infarction within one year of screening, congestive heart failure (unless LVEF ≥ 50 percent as determined by MUGA within 30 days of screening), uncontrolled hypertension (≥ 160 mm Hg/systolic and ≥ 100 mm Hg/diastolic), symptomatic or life-threatening arrhythmia persistent on medication at screening, or clinically evident chronic lung disease unless lung capacity ≥ 55 percent or FEV1 ≥ 60 percent at screening.
• Any underlying medical condition that in the Principal Investigator's opinion will make the administration of study drug hazardous to the patient or would obscure the interpretation of adverse events.
• Medical condition requiring the use of systemic corticosteroids (must be discontinued at least four weeks prior to enrollment. The use of inhaled corticosteroids is acceptable).

For more information, contact the clinical research coordinator at 919-668-1861.