A Phase I, Open-Label, Dose-Escalation, Multidose Study of CDX-1307, a Mannose Receptor-Targeted hCG-β Vaccine, in Patients With Incurable Breast, Colorectal, Pancreatic, Ovarian or Bladder Cancer (CDX-1307-01)
1. Patients must have read, understood, and provided written informed consent and HIPAA
authorization after the nature of the study has been fully explained.
2. Patients must be 18 years of age or older.
3. Patients with incurable breast, colorectal, pancreatic, ovarian or bladder cancer
with measurable or evaluable disease.
4. Patients who have never received prior hCG-β therapy.
5. Patients for whom therapy with potential survival benefit is available, or
disease-specific palliation is the goal of therapy, 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. Patients who have refused standard of care options known to
provide potential survival benefit or disease specific palliation are not eligible
for this study.
6. At least 4 weeks must have elapsed between prior therapy and first dose of the
vaccine. Prior radiation therapy must be completed at least 4 weeks prior to the
first vaccine dose. No prior radiopharmaceuticals within 8 weeks prior to the first
vaccine dose. The patient must have recovered from any clinically significant
toxicity experienced during prior treatment(s).
7. Patients on the following medications may be enrolled into the study if the
medications were initiated 4 weeks or longer 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.
8. Patients must have an ECOG Status of 0 or 1.
9. Patients must have a life expectancy ≥ 16 weeks.
10. Male patients who are sexually active must agree to practice an effective form of
barrier contraception during the course of the study.
11. 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 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
1. 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 1 year] and/or surgically incapable
of bearing children).
2. Previous administration of hCG-β vaccine or therapy.
3. Concurrent treatment with immunosuppressive or immunomodulatory agents.
4. Positive tests for HIV, HBV or HCV.
5. Patients with an active systemic infection requiring antibiotic treatment or a fever
over 100°F within 72 hours prior to enrollment.
6. 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.
7. Patients with active central nervous system metastases, unless previously treated and
asymptomatic for 2 months and not progressive in size or number for 2 months.
8. 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 ≥ 5 years.
9. History of anaphylactic reaction following exposure to humanized or human therapeutic
monoclonal antibodies, or known hypersensitivity to GM-CSF, or yeast derived
10. Patients with any of the following conditions: myocardial infarction within 1 year of
screening, congestive heart failure (unless LVEF ≥ 50% 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% or
FEV1 ≥ 60% at screening.
11. 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.
12. Medical condition requiring the use of systemic corticosteroids (must be discontinued
at least 4 weeks prior to enrollment. The use of inhaled corticosteroids is