Spots Global Cancer Trial Database for MGC018 With or Without MGA012 in Advanced Solid Tumors
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Trial Identification
Brief Title: MGC018 With or Without MGA012 in Advanced Solid Tumors
Official Title: A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti-B7-H3 Antibody Drug Conjugate) Alone and in Combination With MGA012 (Anti-PD-1 Antibody) in Patients With Advanced Solid Tumors
Study ID: NCT03729596
Interventions
Study Description
Brief Summary: The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of vobramitamab duocarmazine (MGC018) in patients with advanced solid tumors. Patients with solid tumors will be enrolled in the Dose Escalation Phase; Cohort Expansion will include metastatic castrate-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), squamous cell carcinoma of the head and neck (SCCHN), and melanoma. Patients who do not experience unacceptable toxicity or meet criteria for permanent discontinuation may undergo additional cycles for up to two years. Patients in Cohort Expansion will be followed for survival every 3 months for 2 years following last dose.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA Department of Medicine - Hematology/Oncology, Santa Monica, California, United States
Sibley Memorial Hospital, Washington, District of Columbia, United States
The Johns Hopkins Kimmel Cancer Center, Baltimore, Maryland, United States
START Midwest, Grand Rapids, Michigan, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Carolina Biooncology Institute, Huntersville, North Carolina, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States
Virginia Cancer Specialist, Fairfax, Virginia, United States
St Vincent's Health Network (Kinghorn Cancer Centre), Darlinghurst, , Australia
Austin Health - Olivia Newton John Cancer Center, Heidelberg, , Australia
Calvary Mater NewCastle, Waratah, , Australia
The University of Queensland - Princess Alexandra Hospital (PAH), Woolloongabba, , Australia
Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie Oddział Kliniczny Onkologii, Krakow, , Poland
Med-Polonia Sp. z o.o., Poznań, , Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy Oddział Badań Wczesnych Faz, Warsaw, , Poland
Magodent Sp. z o.o. Szpital Elbląska Oddział Onkologii Klinicznej/ Chemioterapii, Warszawa, , Poland
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Institut Català D'Oncologia - Hospital Universitari Germans Trias I Pujol, Barcelona, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Hospital Ruber Internacional, Madrid, , Spain
Contact Details
Name: Ashley Ward, M.D.
Affiliation: MacroGenics
Role: STUDY_DIRECTOR
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