Cancer – Current Trials

CDX-110 — Clinical Program for Malignant Glioblastoma
Our lead clinical development program, CDX-110, is an immunotherapy that targets the tumor specific molecule called EGFRvIII, a functional variant of the epidermal growth factor receptor (EGFR), a protein that has been well validated as a target for cancer therapy. Click for More Information.

TRIALS CURRENTLY ACCEPTING PATIENTS

• CDX-110 — Phase II/III Randomized Study: Newly Diagnosed Glioblastoma Multiforme (The “ACT III” trial)
  A Phase II/III Randomized Study of CDX-110 with Radiation and Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme. This ongoing clinical trial investigates the anticancer activity, impact on survival, and safety of the addition of CDX-110 vaccine to standard of care maintenance chemotherapy (with temozolomide) in patients with glioblastoma multiforme. Open Clinical Trial Sites, Click for More Information.

TRIALS NOW CLOSED TO ACCRUAL

• CDX-110 — Phase II Trial: Newly Diagnosed Glioblastoma Multiforme (The “ACTIVATE”/”ACT II” trial)
  A Complementary Trial of an Immunotherapy Vaccine Against Tumor-Specific EGFRvIII. This is an ongoing investigator-initiated trial being conducted at the Brain Tumor Center at the Duke Comprehensive Cancer Center and at the M.D. Anderson Cancer Center in Houston, Texas. This trial is evaluating the safety, immune response, anticancer activity, and impact on survival of the addition of CDX-110 vaccine to standard of care in patients with glioblastoma multiforme.
  
  Twenty three patients have previously been enrolled in the first stage of this trial (“ACTIVATE”), with encouraging results. Following surgery to remove the GBM tumor and standard chemoradiation, patients received intradermal injections of CDX-110 on a biweekly to monthly basis, continuing until progression of disease. CDX-110 was well tolerated and immune responses were generated. Median time to disease progression was 14.8 months, comparing favorably with a matched historical cohort (6.6 months) and published reports using standard of care temozolomide chemotherapy (6.9 months). Median overall survival was 29.1 months, which is more than double that of the matched historical cohort (13 months) and published reports using standard of care temozolomide chemotherapy (14.6 months).
  
  In the second stage of this study, 21 patients received CDX-110 plus maintenance chemotherapy (with temozolomide). Median survival in this trial has not yet been reached (Data presented at ASCO 2007).
  

Our lead APC Targeting Technology product candidate, CDX-1307
This antibody is in development for the treatment of colorectal, pancreatic, bladder and breast cancers that express the beta chain of human chorionic gonadotropin, known as βhCG, an antigen often found in tumors of these types of cancer. The presence of βhCG in these cancers correlates with a poor clinical outcome, suggesting that this molecule may contribute to tumor growth. Normal adult tissues have minimal expression of βhCG, therefore, targeted immune responses are not expected to generate significant side effects. Click for More Information.

TRIALS NOW ACCEPTING PATIENTS

• CDX-1307 — Phase I, Open-Label, Dose-Escalation, Multidose Study: Metastatic Breast Cancer
  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. 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.
• CDX-1307 — Phase I, Open-Label, Dose-Escalation, Multidose Study: Metastatic Breast, Colorectal, Pancreatic, and Bladder cancer.
  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. 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.