Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer

Active:	No
Cancer Type:	Breast Cancer	NCT ID:	NCT01997333
Trial Phases:	Phase II	Protocol IDs:	CDX011-04 (primary)
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Celldex Therapeutics Inc
NCI Full Details:	http://clinicaltrials.gov/show/NCT01997333

Summary

The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an
antibody-drug conjugate) is effective in treating patients who have advanced
Triple-Negative Breast Cancer (TNBC), and whose tumor cells make a protein called
glycoprotein NMB (gpNMB), which CDX-011 binds to. The study will also further
characterize the safety of CDX-011 treatment in this patient population.

Objectives

CDX-011 consists of an antibody attached to a drug, monomethyl auristatin E (MMAE), that
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.

Treatment Sites in Georgia

Piedmont Henry Hospital
1133 Eagles Landing Parkway
Stockbridge, GA 30281
www.piedmont.org

Study Coordinator:

Ann Johnston
678-298-3235

Doctors:

Richard A. Carter MD

Gerald A. Goldklang MD

Padrica Hopkins-Menchion MD

Palamalai Mahizhnan MD

Gurinderjit K. Sidhu MD

Jorge A. Spinolo MD

Lijo Simpson MD

Summit Cancer Care - Statesboro
16741 Highway 67 South
Suite B
Statesboro, GA 30458
www.summitcancercare.com

Summit Cancer Care at Curtis and Elizabeth Anderson Cancer Institute
4700 Waters Avenue
Savannah, GA 31405
www.summitcancercare.com

Summit Cancer Care at the Nancy N. Lewis and J.C. Lewis Cancer & Research Pavilion
225 Candler Drive
Suite 300
Savannah, GA 31405
www.summitcancercare.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.