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Brief Title: Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma
Official Title: An Open-Label Multicenter Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Subjects With Advanced Hepatocellular Carcinoma
Study ID: NCT02834780
Brief Summary: The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics of H3B-6527.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
UC Irvine Medical Center, Orange, California, United States
UCLA Medical Center, Santa Monica, California, United States
Georgetown Unversity Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States
Northwestern Unversity, Chicago, Illinois, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
John theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Duke University Cancer Center, Durham, North Carolina, United States
University of Cincinnati Cancer Institute, Cincinnati, Ohio, United States
University of Pennsylsvania - Perelman Cancer Center for Advanced Medicine, Philadelphia, Pennsylvania, United States
Simmons Comprehensive Cancer Center, Dallas, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
McGuire VA Medical Center, Richmond, Virginia, United States
UCL Cliniques universitaires Saint-Luc, Woluwe-Saint-Lambert, Brussels, Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Cross Cancer Institute, Edmonton, Alberta, Canada
Jurvanski Cancer Center, Hamilton, Ontario, Canada
Institut Bergonié, Bordeaux, , France
Centre Oscar Lambret, Lille, , France
Hôpital Haut-Lévêque - CHU de Bordeaux, Pessac, , France
Centre Eugène Marquis, Rennes, , France
IRCCS Istituto Scientifico Romagnolo per lo studio e la cura dei tumori - U.O. di Oncologia Medica, Meldola, , Italy
IRCCS Ospedale San Raffaele S.r.l. - PPDS, Milano, , Italy
Azienda Ospedaliero Universitaria - Policlinico di Modena, Modena, , Italy
Asan Medical Center, Seoul, , Korea, Republic of
Altay Regional Oncology Center, Barnaul, Altay, Re, Russian Federation
Russian Oncology Research Center n a N N Blokhin, Moscow, , Russian Federation
Omsk Regional Oncology Center, Omsk, , Russian Federation
Railway Clinical Hospital JSC RZhD, Saint Petersburg, , Russian Federation
City Clinical Oncology Dispensary, Saint Petersburg, , Russian Federation
National University Cancer Insitute, Singapore, , Singapore
Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Spain
Clínica Universidad de Navarra, Pamplona, Navarra, Spain
Hospital Universitario de Badajoz, Badajoz, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
General Universitario Gregorio Maranon, Madrid, , Spain
START Madrid FJD, Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Sarah Cannon Research Institute UK - SCRI - PPDS, London, , United Kingdom