CDX-1307 : Phase I Incurable

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, or Bladder 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 incurable breast, colorectal, pancreatic, or bladder cancer.

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

The trial is currently open to accrual.  Eighteen patients have previously been treated in three dose-escalating cohorts.  The study is currently open to accrual for a fourth cohort of six patients who will receive CDX-1307 concurrent with the immune activator, GM-CSF.

Patient Eligibility

Major entry criteria include:

• Incurable breast, colorectal, pancreatic, or bladder cancer
• Previously received and experienced disease progression during any available anti-cancer therapies offering potential survival benefit or disease-specific palliation
• 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.