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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: MD

Affiliation: Amgen

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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