Breast Cancer CDX-011 (METRIC)

April 11, 2017

Sponsor: Celldex

Number: CDX-011 (METRIC)

The main purpose of this study is to see whether CDX-011 (Glembatumumab Vedotin, a monoclonal antibody-drug conjugate. Designed to harness the targeting ability of monoclonal antibodies by linking them to cell-killing agents) is effective in treating patients who have advanced Triple-Negative Breast Cancer (triple negative breast cancer diagnosis means that the tumor is estrogen receptor-negative, progesterone receptor-negative and HER2-negative), and whose tumor cells make a protein called glycoprotein NMB (gpNMB), which CDX-011 binds to. Estrogen and progesterone receptors are receptors that may be found in breast cancer cells. Her-2 is an oncogene, a gene that has the potential to cause cancer. The study will also further characterize the safety of CDX-011 treatment in this patient population.

CDX-011 consists of an antibody attached to a drug, Monomethyl Auristatin E, which can kill cancer cells. The antibody delivers the drug to cancer cells by attaching to a protein called glycoprotein NMB (gpNMB) that is expressed on the cancer cell. The MMAE is then released inside of the cell, where it interferes with cell growth and may lead to cell death.

This study will examine the efficacy and safety of CDX-011 in patients with advanced TNBC that makes the gpNMB protein. The effect of CDX-011 will be compared to treatment with Capecitabine.

Eligible patients who enroll in the study will be randomly assigned (by chance) to receive treatment with CDX-011 or with Capecitabine. For every three patients enrolled, two will receive CDX-011 and one will receive treatment with Capecitabine. All patients enrolled in the study will be closely monitored to determine if their cancer is responding to treatment and for any side effects that may occur.

Who’s eligible: 

Patients should have had no more than one prior chemotherapy-containing regimen for advanced breast cancer (locally advanced/recurrent or metastatic- breast cancer that has spread beyond the breast to the chest wall or the skin of the breast, too many lymph nodes in the underarm area, to other organs, or that has come back in the same or opposite breast or chest wall). Prior receipt of taxane- and anthracycline-containing chemotherapy. These therapies must have been received as either:

• Neoadjuvant/adjuvant treatment (before/after surgery for the treatment of breast cancer) with progressive disease/recurrence no sooner than 6 months after completion of therapy (ie, “exposed” to therapy), or
• As treatment for advanced disease with progressive disease/recurrence during treatment or within 6 months of completion of treatment (ie, “resistant” to therapy).

Patients who received anthracycline therapy for advanced disease without progression within 6 months will also be eligible if no further anthracycline therapy is indicated (such as patients who have received cumulative doses of 240 mg/m2of Doxorubicin or Doxorubicin equivalents).

This study is for patients age 18 and older

Available at: The Hospital of Central Connecticut- The Cancer Center of Central Connecticut.