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

Completed · Phase 2

Conditions studied: Metastatic gpNMB Over-expressing Triple Negative Breast Cancer

In brief

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.

Key facts

Study ID

NCT01997333

Run by

Celldex Therapeutics

People needed

327

Starts

2013-11-01

Expected to finish

2018-08-07

Last updated by the study team

2019-03-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Among other criteria, patients must meet all of the following conditions to be eligible for the study:
• Diagnosed with metastatic (i.e., cancer that has spread) TNBC
• minimal or no expression of estrogen and progesterone receptors (ER/PR) <10% of cells positive by immunohistochemistry
• HER 2 staining 0 or 1+ by IHC or copy number <4.0 signals/cell
• Documented progression of disease based on radiographic, clinical or pathologic assessment during or subsequent to the last anticancer regimen received.
• Breast cancer tumor confirmed to express gpNMB. This will be determined by submitting a tissue sample from the advanced (locally advanced/recurrent or metastatic) disease setting to a central laboratory for analysis.
• Received no more than two prior chemotherapy treatments for advanced (locally advanced/recurrent or metastatic) breast cancer.
• Prior chemotherapy treatment must have contained an anthracycline (e.g. doxorubicin or Doxil) if clinically indicated and a taxane (eg: Taxol).
• ECOG performance status of 0 - 1.
• Adequate bone marrow, liver and renal function.
• Exclusion:
• Among other criteria, patients who meet any of the following conditions are NOT eligible for the study:
• Progression/recurrence of breast cancer during or within 3 months of completion of neoadjuvant or adjuvant chemotherapy.
• Ongoing neuropathy or other chemotherapy or radiation-related toxicities that are moderate (Grade 2) or worse in severity.
• Known brain metastases, unless previously treated and asymptomatic for 2 months and not progressive in size or number for 2 months.
• Significant cardiovascular disease.
• Previously received capecitabine and discontinued due to progression or intolerance; previously received CDX-011 or other MMAE containing agents.
• Active systemic infection requiring treatment. Infection controlled by oral therapy will not be exclusionary.
• Chronic use of systemic corticosteroids.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of South Alabama Cancer Research Insititute — Mobile, Alabama, United States
• Arizona Cancer Research Alliance — Glendale, Arizona, United States
• Arizona Cancer Center — Tucson, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Compassionate Care Research Group — Fountain Valley, California, United States
• St. Jude Heritage Medical Group — Fullerton, California, United States
• USC Norris Comprehensive Cancer Center and Hospital — Los Angeles, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• Pacific Cancer Care — Salinas, California, United States
• University of California San Francisco — San Francisco, California, United States
• Kaiser Permaente — Vallejo, California, United States
• Wellness Hematology Oncology — West Hills, California, United States
• University of Miami Miller School of Medicine — Deerfield Beach, Florida, United States
• Florida Cancer Specialists South — Fort Myers, Florida, United States
• Memorial Regional Hospital — Hollywood, Florida, United States
• Baptist Cancer Institute — Jacksonville, Florida, United States
• Florida Cancer Specialists — New Port Richey, Florida, United States
• Tallahassee Memorial HealthCare — Tallahassee, Florida, United States
• Peachtree Hematology Oncology Consultants, PC — Atlanta, Georgia, United States
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
• Georgia Cancer Specialists Clinic — Atlanta, Georgia, United States
• Northwest Georgia Oncology Centers P.C. — Marietta, Georgia, United States
• Summit Cancer Care, PC-Savannah — Savannah, Georgia, United States
• Alabama Oncology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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