Spots Global Cancer Trial Database for A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms
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Trial Identification
Brief Title: A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms
Official Title: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of MGD013, A Bispecific DART® Protein Binding PD-1 and LAG-3 in Patients With Unresectable or Metastatic Neoplasms
Study ID: NCT03219268
Study Description
Brief Summary: The primary goal of this Phase 1 study is to characterize the safety and tolerability of tebotelimab and establish the maximum tolerated dose (MTD) of tebotelimab in advanced solid tumors, and tebotelimab in combination with margetuximab in HER2+ advanced solid tumors. Pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and the anti-tumor activity of tebotelimab will also be assessed.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
UCLA Hematology & Oncology Clinic, Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
Florida Cancer Specialists & Research Institute, Sarasota, Florida, United States
University of Chicago Medicine, Chicago, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Massachusetts General Hospital and Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Duke University Medical Center, Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Stephenson Cancer Center, The University of Oklahoma, Oklahoma City, Oklahoma, United States
University of Pennsylvania, Abramson Cancer Center, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
The University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia
Calvary Mater Newcastle, Waratah, New South Wales, Australia
Southern Medical Day Care Centre, Wollongong, New South Wales, Australia
Austin Health Melbourne, Heidelberg, Victoria, Australia
"Complex Oncology Center - Burgas" EOOD, Burgas, , Bulgaria
"Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda" EAD, Sofia, Sofia, , Bulgaria
Multiprofile Hospital for Active Treatment "Serdika" EOOD, Sofia, Sofia, , Bulgaria
Prince of Wales Hospital, Shatin, , Hong Kong
Pratia MCM Kraków, Kraków, Malopolskie, Poland
BioVirtus Research Site Sp. Z o.o. / Biovirtus Centrum Medyczne, Józefów, Masovian, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Warszawa, Mazowieckie, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Warszawa, Mazowieckie, Poland
Med-Polonia Sp. z o.o., Poznań, , Poland
Vall d'Hebron Institute of Oncology, Barcelona, , Spain
Hospital Ruber Internacional, Madrid, , Spain
START Madrid-CIOCC, Hospital HM Sanchinarro, Madrid, , Spain
King Chulalongkorn Memorial Hospital, Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai, , Thailand
Songklanagarind Hospital, Songkhla, , Thailand
Communal Nonprofit Enterprise "Cherkassy Regional Oncology Dispensary" of Cherkassy Regional Council, Cherkassy, Cherkasy Region, Ukraine
Communal Nonprofit Enterprise Podillia Regional Center of Oncology of Vinnytsia Regional Council, Vinnytsia, Vinnytsa Region, Ukraine
Communal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council, Dnipro, , Ukraine
Communal Nonprofit Enterprise "Prykarpatsky Clinical Oncological Centre of Ivano-Frankivska Regional Council", Ivano-Frankivs'k, , Ukraine
Municipal Non-Profit Enterprise of Sumy Regional Council "Sumy Regional Clinical Oncology Dispensary", Sumy, , Ukraine
Communal Nonprofit Enterprise "Central City Clinical Hospital of Uzhhorod City Council", City Oncology Center, State Higher Educational Institution <<Uzhhorod National University>>, Uzhgorod, , Ukraine
Contact Details
Name: Ashley Ward, MD
Affiliation: MacroGenics
Role: STUDY_DIRECTOR
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