Phase I Study of CDX-1307, hCG-B Vaccine, for Patients With Incurable, Locally Advanced or Metastatic Breast, Colorectal, Pancreatic, Bladder or Ovarian Cancer

1. Patients must have incurable, metastatic or unresectable locally advanced breast, colorectal, pancreatic, bladder or ovarian cancer with measurable or evaluable-only disease. Locally advanced breast cancer is defined as inflammatory breast cancer with biopsy-proven skin involvement, or chest wall recurrence. Locally advanced disease of other histologies is defined according to the standard definition for that disease. Evaluable-only disease includes bone only or unresectable skin/chest wall only metastases, but does not include malignant effusion(s) only. Cancer with elevated serum tumor marker(s) (e.g. CA27.29, carcinoembryonic antigen, etc.) only does not constitute evaluable disease.

2. Patients must be 18 years of age or older.

3. Both genders may be enrolled.

4. At least 4 weeks must have elapsed between prior therapy and initiation of treatment with CDX-1307. Prior radiation therapy must be completed at least 4 weeks prior to enrollment. No prior radiopharmaceuticals within 8 weeks prior to enrollment. The patient must have recovered from any clinically significant toxicity experienced during prior treatment(s).

5. Patients on the following medications may be enrolled into the study if the medications were initiated ≥ 8 weeks prior to Screening and if no dosing changes are anticipated during the study:

1. Hormonal therapy including gonadotropin releasing hormone (GnRh) agonist, antiandrogens, selective estrogen receptor modulators (SERMs), aromatase inhibitors, and progestins.

2. Bisphosphonates.

6. Patients must have an ECOG Performance Status of 0 or 1.

7. Breast cancer patients must have received and progressed through at least one line of chemotherapy or endocrine therapy for metastatic or unresectable locally advanced breast cancer. Patients with HER2-positive breast cancer must have received and progressed through at least one line of chemotherapy plus trastuzumab, or endocrine therapy plus trastuzumab, for metastatic or unresectable locally advanced breast cancer. For incurable colorectal, pancreatic, bladder, or ovarian cancer, where therapy with potential survival benefit is available or where disease-specific palliation is the goal of therapy, patients must have received these appropriate standard of care therapies and experienced recurrence or progression while on that care. If no such therapy is available, patients with progressive disease may be enrolled. Chemotherapy or radiation must be discontinued at least 4 weeks prior to initiation of vaccination with CDX-1307.

8. Patients must have a life expectancy ≥ 16 weeks.

9. Male patients who are sexually active must agree to practice an effective form of barrier contraception during the course of the study.

10. Screening laboratory values must 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.

\* 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

What this study is about