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Brief Title: AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors
Official Title: A Phase 1/1b/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 Alone and in Combination With Docetaxel in Subjects With Advanced MTAP-null Solid Tumors
Study ID: NCT05094336
Brief Summary: The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AMG 193 alone and in combination with docetaxel in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors. The primary objective of Part 3 of this study is to evaluate the objective response rate (ORR) of AMG 193 in adult participants with metastatic or locally advanced MTAP-null solid tumors.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope National Medical Center, Duarte, California, United States
University of California at SF, San Francisco, California, United States
Goshen Health Systems, Goshen, Indiana, United States
Indiana University, Indianapolis, Indiana, United States
Community Health Network MD Anderson Cancer Center - North, Indianapolis, Indiana, United States
University of Maryland Medical Center, Baltimore, Maryland, United States
American Oncology Partners, PA, Bethesda, Maryland, United States
Washington University, Saint Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey, Bronx, New York, United States
Northwell Health Monter Cancer Center, Lake Success, New York, United States
New York University Langone Health, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Cancer Pavillion, Pittsburgh, Pennsylvania, United States
Mary Crowley Cancer Research, Dallas, Texas, United States
Center for Oncology and Blood Disorders, Houston, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Lumi Research, Kingwood, Texas, United States
South Texas Accelerated Research Therapeutics, San Antonio, Texas, United States
Chris OBrien Lifehouse, Camperdown, New South Wales, Australia
Medizinische Universitaet Graz, Graz, , Austria
Landeskrankenhaus Salzburg, Salzburg, , Austria
Universite Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Jessa Ziekenhuis - Campus Virga Jesse, Hasselt, , Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg, Leuven, , Belgium
Cross Cancer Institute, Edmonton, Alberta, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Centre Georges François Leclerc, Dijon cedex, , France
Centre Oscar Lambret, Lille, , France
Gustave Roussy, Villejuif, , France
Universitaetsklinikum Halle - Saale, Halle (Saale), , Germany
Universitaetsklinikum Heidelberg, Heidelberg, , Germany
Universitaetsklinikum Ulm, Ulm, , Germany
Universitaetsklinikum Wuerzburg, Wuerzburg, , Germany
University of Hong Kong, Queen Mary Hospital, Hong Kong, , Hong Kong
Prince of Wales Hospital, Shatin, New Territories, , Hong Kong
Aichi Cancer Center, Nagoya-shi, Aichi, Japan
National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Istituto Oncologico della Svizzera Italiana, Bellinzona, , Switzerland
Inselspital Bern, Bern, , Switzerland
Hopitaux Universitaires de Geneve, Geneve 14, , Switzerland
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation, Taoyuan, , Taiwan
Sarah Cannon Research Institute UK, London, , United Kingdom
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR