Spots Global Cancer Trial Database for A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors
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Trial Identification
Brief Title: A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors
Official Title: A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of INCMGA00012 in Patients With Advanced Solid Tumors
Study ID: NCT03059823
Interventions
Study Description
Brief Summary: The primary goal of this Phase 1 study is to characterize the safety and tolerability of INCMGA00012 and establish the maximum tolerated dose (MTD) of INCMGA00012 administered on either every two week or every four week schedules of administration among patients with solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of INCMGA00012 will also be assessed. The purpose of Amendment 5 is to obtain additional safety experience at the newly defined recommended Phase 2 dose of 500 mg every 4 weeks in patients with endometrial cancer, specifically either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Additionally, every 3 week (Q3W) flat-dosing will be studied in an additional tumor agnostic cohort.
Detailed Description: This study is a Phase 1, open-label, dose escalation and cohort expansion study designed to characterize the safety, tolerability, PK, PD, immunogenicity, and preliminary anti-tumor activity of INCMGA00012 administered IV every 2, 3, or 4 weeks in patients with relapsed/refractory, unresectable locally advanced or metastatic solid tumors. In the initial phase of the study, two dose schedules will be assessed in dose escalation, once every two weeks and once every four weeks administration of single agent INCMGA00012. Following the establishment of an MTD, additional patients will enroll in expansion cohorts of specific tumor types and/or INCMGA00012 dose. The Cohort Expansion Phase will include tumor-specific cohorts, consisting of patients with endometrial cancer (unselected \[up to n = 35\] and MSI-H or dMMR \[up to n = 70\]), cervical cancer (up to n = 35), sarcoma (up to n = 35), non-small cell lung cancer (NSCLC) (up to n = 35), and 3 cohorts of any tumor histology (tumor-agnostic) (up to n = 15) who will receive flat dosing: 1 cohort treated with INCMGA00012 500 mg Q4W, 1 cohort with INCMGA00012 750 mg Q4W, and 1 cohort treated with INCMGA00012 375 mg Q3W.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Honor Health Research Institute, Scottsdale, Arizona, United States
South Texas Accelerated Research Therapeutics, Grand Rapids, Michigan, United States
Rutgers Cancer Institute of Nj, New Brunswick, New Jersey, United States
Carolina Bio-Oncology Institute, Pllc, Huntersville, North Carolina, United States
Houston Methodist Hospital, Houston, Texas, United States
University of Texas Md Anderson Cancer Center, Houston, Texas, United States
South Texas Accelerated Research Therapeutics, San Antonio, Texas, United States
Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, United States
Chris Obrien Lifehouse, Camperdown, New South Wales, Australia
St Vincent'S Hospital Sydney, Darlinghurst, New South Wales, Australia
Universitair Ziekenhuis (Uz) Leuven, Leuven, , Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman, Liege, , Belgium
COMPLEX ONCOLOGY CENTER � BURGAS EOOD, Burgas, , Bulgaria
Mc Women'S Health-Nadezhda Eood, Sofia, , Bulgaria
Acibadem Cityclinica Mhat Tokuda, Sofia, , Bulgaria
Umhat in Oncology, Sofia, , Bulgaria
Peking Union Medical College Hospital, Beijing, , China
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, , China
Beijing Cancer Hospital, Beijing, , China
Peking University Third Hospital, Beijing, , China
Xiangya Hospital Central South University, Changsha, , China
Hunan Cancer Hospital, Changsha, , China
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University, Guangzhou, , China
The First Affiliated Hospital Sun Yat-Sen University, Guangzhou, , China
Qilu Hospital of Shandong University, Jinan, , China
Yunnan Cancer Hospital, Kunming, , China
Zhongda Hospital Southeast University, Nanjing, , China
The Fourth Hospital of Hebei Medical University, Shijiazhuang, , China
The Second Hospital of Shanxi Medical University, Taiyuan, , China
Tongji Hospital Huazhong University of Science and Technology, Wuhan, , China
The First Affiliated Hospital of Xian Jiaotong University, Xi'an, , China
The First Affiliated Hospital of Xiamen University, Xiamen, , China
Henan Cancer Hostipal, Zhengzhou, , China
Docrates Cancer Center, Helsinki, , Finland
Turku University Hospital, Turku, , Finland
Institut Bergonie, Bordeaux, , France
Centre Leon Berard, Lyon, , France
Centre Antoine Lacassagne, Nice, , France
Hospital Universitaires de Geneve, Paris, , France
Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, , France
Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau, Saint-herblain, , France
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole, Toulouse, , France
Institut Gustave Roussy, Villejuif, , France
Charite Universitaetsmedizin Berlin - Campus Charite Mitte, Berlin, , Germany
CHARITE - UNIVERSIT�TSMEDIZIN BERLIN, Berlin, , Germany
University Clinic Carl Gustav Carus Technical University Dresden, Dresden, , Germany
Universitatsklinikum Essen, Essen, , Germany
University Medical Center Freiburg, Freiburg, , Germany
STADTISCHE KLINIKUM MUNCHEN � NEUPERLACH KLINIK FUR HAMATOLOGIE UND ONKOLOGIE, Munchen, , Germany
University Hospital Grosshadern Munich, Munich, , Germany
Azienda Ospedaliero Universitaria Ospedali Riuniti, Ancona, , Italy
Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo, Candiolo, , Italy
Istituto Nazionale Tumori Irccs Fondazione Pascale, Naples, , Italy
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore, Rome, , Italy
Riga East University Hospsital, Riga, , Latvia
National Cancer Institute, Vilnius, , Lithuania
Auckland City Hospital, Auckland, , New Zealand
Wellington Hospital, Wellington, , New Zealand
SZPITALE WOJEW�DZKIE W GDYNI SP�LKA Z OGRANICZONA ODPOWIEDZIALNOSCIA, Gdynia, , Poland
University Hospital Krakow, Department of Oncology, Krakow, , Poland
Ko-Med Centra Kliniczne Osrodek Badan Klinicznych W Lublinie, Lublin, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Msw Z W-McO W Olsztynie, Olsztyn, , Poland
Biovirtus Research Site, Otwock, , Poland
Szpital Kliniczny Przemienienia Panskiego, Poznan, , Poland
Katedra I Klinika Onkologii Um W Poznaniu Oddzial Ginekologii Onkologicznej, Poznan, , Poland
Medical University of Warsaw - 2Nd Department Obstetric and Gynecology, Warsaw, , Poland
Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie, Warsaw, , Poland
Hospital General Universitario Vall D Hebron, Barcelona, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario de La Paz, Madrid, , Spain
Centro Integral Oncologico Clara Campal (Ciocc), Madrid, , Spain
Multifield Clinical Hospital No 4, Dnipro, , Ukraine
Regional Clinical Oncology Center Facility of State Higher Educational Institution, Ivano-frankivsk, , Ukraine
Rmi Sumy Regional Clinical Oncology Dispensary, Sumy, , Ukraine
Uzhgorod National University Clinical Base Uzhgorod Central City Clinical Hospital, Uzhgorod, , Ukraine
Podillia Regional Center of Oncology - Chemotherapy Department, Vinnytsia, , Ukraine
Sarah Cannon Research Institute, London, , United Kingdom
The Christie Nhs Foundation Trust Uk, Manchester, , United Kingdom
The Royal Marsden Nhs Foundation Trust - Chelsea, Sutton, , United Kingdom
Contact Details
Name: Incyte Medical Monitor
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR
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