CDX-1307 : Phase I

A Phase I, Open-Label, Dose-Escalation, Multidose Study of CDX-1307, a Mannose Receptor-Targeted hCG-β Vaccine, in Patients with Locally Advanced or Metastatic Breast Cancer

About the Clinical Trial

The purpose of this trial is to evaluate the safety, dose-limiting toxicities, immune response, and anticancer activity of CDX-1307 vaccine in patients with metastatic or unresectable locally advanced breast cancer.

Patients receive CDX-1307 intravenously, every two weeks for a total of four doses.

The trial is currently open to accrual. Up to 30 patients will be treated in four dose-escalating cohorts.

Patient Eligibility

Patients must have:

• Metastatic or unresectable locally advanced breast cancer
• Received and experienced disease progression during at least one line of chemotherapy or endocrine therapy (with trastuzumab, if HER2-positive breast cancer).
• If female, must be post-menopausal and/or surgically incapable of bearing children. (Women of childbearing potential are excluded.)

For more information on enrollment, please contact Celldex at 908-454-7120 ext. 324