MedPath

Glembatumumab vedotin

Generic Name
Glembatumumab vedotin
Drug Type
Biotech
CAS Number
1182215-65-1
Unique Ingredient Identifier
1568H6A58U
Background

A conjugate of an anti-glycoprotein non-metastatic melanoma protein B mAb and monomethyl auristatin E for the treatment of melanoma and breast cancer.

Indication

Investigated for use/treatment in melanoma.

Pilot Study of Glembatumumab Vedotin Following Doxorubicin and Cytoxan as Neo-adjuvant Therapy in Gp-NMB-expressing High Risk Triple Negative Breast Cancer

Early Phase 1
Withdrawn
Conditions
Triple Negative Breast Cancer
Interventions
First Posted Date
2018-03-22
Last Posted Date
2024-12-09
Lead Sponsor
University of Virginia
Registration Number
NCT03473691

Glembatumumab Vedotin, Nivolumab, and Ipilimumab in Treating Patients With Advanced Metastatic Solid Tumors That Cannot Be Removed by Surgery

Phase 1
Withdrawn
Conditions
Advanced Malignant Solid Neoplasm
Estrogen Receptor Negative
GPNMB Positive
HER2/Neu Negative
Stage IV Breast Cancer AJCC v6 and v7
Stage IV Cutaneous Melanoma AJCC v6 and v7
Metastatic Malignant Solid Neoplasm
Progesterone Receptor Negative
Stage III Breast Cancer AJCC v7
Stage III Uveal Melanoma AJCC v7
Interventions
Biological: Ipilimumab
Other: Laboratory Biomarker Analysis
Biological: Nivolumab
Other: Pharmacological Study
First Posted Date
2017-10-31
Last Posted Date
2018-07-18
Lead Sponsor
National Cancer Institute (NCI)
Registration Number
NCT03326258

Individual Patient Expanded Access-Glembatumumab Vedotin

Conditions
Metastatic gpNMB Expressing Triple Negative Breast Cancer
First Posted Date
2017-03-01
Last Posted Date
2018-05-21
Lead Sponsor
Celldex Therapeutics
Registration Number
NCT03067935

Glembatumumab Vedotin in Treating Patients With Recurrent or Refractory Osteosarcoma

Phase 2
Completed
Conditions
Recurrent Osteosarcoma
Interventions
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
First Posted Date
2015-07-02
Last Posted Date
2022-01-18
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
22
Registration Number
NCT02487979
Locations
🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

🇺🇸

Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida, United States

🇺🇸

Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States

and more 152 locations

Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma

Phase 2
Completed
Conditions
Recurrent Uveal Melanoma
Stage IV Uveal Melanoma AJCC v7
Interventions
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
First Posted Date
2015-02-16
Last Posted Date
2020-08-21
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
37
Registration Number
NCT02363283
Locations
🇺🇸

University of Chicago Medicine-Orland Park, Orland Park, Illinois, United States

🇺🇸

University of Kansas Clinical Research Center, Fairway, Kansas, United States

🇺🇸

UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States

and more 22 locations

A Study of Glembatumumab Vedotin as Monotherapy or in Combination With Immunotherapies in Patients With Advanced Melanoma

Phase 2
Terminated
Conditions
Melanoma
Interventions
Drug: glembatumumab vedotin and varlilumab
Drug: glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab)
Drug: glembatumumab vedotin and CDX-301
First Posted Date
2014-11-27
Last Posted Date
2019-09-06
Lead Sponsor
Celldex Therapeutics
Target Recruit Count
132
Registration Number
NCT02302339
Locations
🇺🇸

Florida Cancer Specialists, West Palm Beach, Florida, United States

🇺🇸

Henry Ford Hospital, Detroit, Michigan, United States

🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

and more 10 locations

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

Phase 2
Completed
Conditions
Metastatic gpNMB Over-expressing Triple Negative Breast Cancer
Interventions
First Posted Date
2013-11-28
Last Posted Date
2019-03-08
Lead Sponsor
Celldex Therapeutics
Target Recruit Count
327
Registration Number
NCT01997333
Locations
🇺🇸

Winship Cancer Institute, Emory University, Atlanta, Georgia, United States

🇮🇹

Fondazione Policlinico Universitario A Gemelli, Roma, Lazio, Italy

🇪🇸

Hospital Regional Universitario de Malaga - Hospital General, Malaga, Málaga, Spain

and more 137 locations

A Study of CDX-011 (CR011-vcMMAE) in Patients With Advanced GPNMB-expressing Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
Drug: "Investigator's Choice" chemotherapy
First Posted Date
2010-07-05
Last Posted Date
2017-07-02
Lead Sponsor
Celldex Therapeutics
Target Recruit Count
120
Registration Number
NCT01156753
Locations
🇺🇸

USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States

🇺🇸

The Angeles Clinic and Research Institute, Los Angeles, California, United States

🇺🇸

Arizona Cancer Center, Tucson, Arizona, United States

and more 21 locations

Study of CR011-vcMMAE to Treat Locally Advanced or Metastatic Breast Cancer

Phase 1
Completed
Conditions
Breast Cancer
First Posted Date
2008-06-24
Last Posted Date
2015-02-19
Lead Sponsor
CuraGen Corporation
Target Recruit Count
42
Registration Number
NCT00704158
Locations
🇺🇸

Florida Cancer Specialists, Ft. Myers, Florida, United States

🇺🇸

Hematology Oncology Associates, Lake Worth, Florida, United States

🇺🇸

Georgia Cancer Specialists, Atlanta, Georgia, United States

and more 2 locations

A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma

Phase 1
Completed
Conditions
Unresectable Stage III or Stage IV Melanoma
First Posted Date
2006-12-19
Last Posted Date
2015-02-19
Lead Sponsor
CuraGen Corporation
Target Recruit Count
117
Registration Number
NCT00412828
Locations
🇺🇸

New York University Medical Center, New York, New York, United States

🇺🇸

Angeles Clinic and Research Institute, Santa Monica, California, United States

🇺🇸

M.D. Anderson Cancer Center, Houston, Texas, United States

and more 1 locations
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