A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
Start Date
1/27/2021
Completion Date
6/1/2028
Summary
This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to: * Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan * Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan * Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan
Detailed Description
ART0380 is a new investigational medicinal product that is a potent and selective inhibitor of Ataxia telangiectasia and Rad3-related (ATR). ART0380 is being developed as an oral anti-cancer agent for the treatment of participants with cancers that harbor defects in deoxyribonucleic acid (DNA) repair and in combination with agents including those that cause DNA damage. This study is an open-label Phase I/IIa study designed to evaluate the safety, tolerability, PK and preliminary efficacy of ART0380 as monotherapy or in combination with gemcitabine or irinotecan in participants with advanced or metastatic solid tumors, advanced or solid tumors that fail to express Ataxia-Telangiectasia Mutated protein kinase (ATM), and high grade serous ovarian, primary peritoneal or fallopian tube carcinoma.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ART0380
Gemcitabine
Irinotecan
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294-3300
United States
Mayo Clinic (Arizona)
Scottsdale, Arizona 85259
United States
University of Arkansas - Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas 72205
United States
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Sansum Clinic
Santa Barbara, California 93105
United States
Providence Medical Foundation
Santa Rosa, California 95403
United States
Rocky Mountain Cancer Center
Denver, Colorado 80218
United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado 80218
United States
Florida Cancer Specialists
Fort Myers, Florida 33901
United States
Mayo Clinic (Florida)
Jacksonville, Florida 32224
United States
Cancer Specialists of North Florida
Jacksonville, Florida 32256
United States
Florida Cancer Specialists
Orlando, Florida 32827
United States
Florida Cancer Specialists
Sarasota, Florida 34232
United States
Florida Cancer Specialists
West Palm Beach, Florida 33401
United States
Hope and Healing Cancer Services
Hinsdale, Illinois 60521
United States
Community Health Network
Indianapolis, Indiana 46250
United States
Our Lady of the Lake
Baton Rouge, Louisiana 70808
United States
Maryland Oncology Hematology - Primary
Columbia, Maryland 21044
United States
Minnesota Oncology Hematology
Maple Grove, Minnesota 55369
United States
Mayo Clinic (Minnesota)
Rochester, Minnesota 55905
United States
Washington University
St Louis, Missouri 63110
United States
Hematology Oncology Associates of Central New York
East Syracuse, New York 13057
United States
Northwell Health Cancer Institute
Lake Success, New York 11042
United States
Oncology Hematology Care Primary
Cincinnati, Ohio 45242
United States
Taylor Cancer Research Center
Maumee, Ohio 43537
United States
Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Oregon Health & Science University
Portland, Oregon 97239
United States
University of Pennsylvania / Abramson Cancer Center
Philadelphia, Pennsylvania 19104
United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
Philadelphia, Pennsylvania 19107
United States
Tennessee Oncology, PLLC
Chattanooga, Tennessee 37404
United States
Baptist Cancer Center
Memphis, Tennessee 38120
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
Vanderbilt Medical Center
Nashville, Tennessee 37232
United States
Texas Oncology - Central/South Texas
Austin, Texas 78705
United States
Mary Crowley Cancer Research
Dallas, Texas 75230
United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas 75246
United States
Texas Oncology - Northeast Texas
Flower Mound, Texas 75028
United States
Oncology Consultants
Houston, Texas 77030
United States
Texas Oncology - San Antonio
San Antonio, Texas 78240
United States
Utah Cancer Specialists
Salt Lake City, Utah 84106
United States
Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
Institut Gustave Roussy
Villejuif, Cedex 94805
France
Institut Bergonie
Bordeau, 33076
France
Marseille University Hospital Timone
Marseille, 13005
France
Saint-Louis Hospital
Paris, 75010
France
Hospital Saint-Antoine
Paris, 75012
France
Hospital de la Pitié-Salpêtrière
Paris, 75013
France
Hospital General Universitario de Elche
Elche, Alicante 03203
Spain
H. Parc Tauli
Sabadell, Barcelona 08208
Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria 39008
Spain
Next Oncology Barcelona, IOB
Barcelona, Catalonia 08023
Spain
Hospital Arnau de Vilanova
Lleida, Catalonia 25198
Spain
Hospital Universitario La Paz
Madrid, Madrid 28046
Spain
Next - Hospital Quironsalud Madrid
Pozuelo de Alarcón, Madrid 28223
Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia 30120
Spain
Clínica Universidad de Navarra
Madrid, Planta -2 28027
Spain
Hospital Clínico Universitario de Santiago (CHUS)
A Coruña, 00000
Spain
Hospital Teresa Herrera (CHUAC)
A Coruña, 15006
Spain
Institut Català d'Oncologia Badalona - Hospital Germans Trias i Pujol
Badalona, 08916
Spain
Vall d'Hebron Institute of Oncology (VIHO)
Barcelona, 08035
Spain
Hospital Clinic de Barcelona
Barcelona, 08036
Spain
ICO Hospitalet
Barcelona, 08903
Spain
Hospital Universitario Reina Sofia de Córdoba
Córdoba, 14004
Spain
Hospital Universitari Doctor Josep Trueta- ICO de Girona
Girona, 17007
Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Spain
MD Anderson Cancer Center (Madrid
Madrid, 28033
Spain
Hospital Clinico San Carlos
Madrid, 28040
Spain
START Madrid Fundacion Jimenez Diaz
Madrid, 28040
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
START Madrid (Hospital San Chinarro)
Madrid, 28050
Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Spain
Hospital Universitario De Navarra
Pamplona, 31008
Spain
START Rioja
Rioja, 26006
Spain
Hospital Virgen Macarena
Seville, 41009
Spain
Hospital Virgen del Rocío
Seville, 41013
Spain
Instituto Valenciano de Oncología (IVO)
Valencia, 00000
Spain
Incliva Biomedical Research Institute, University of Valencia
Valencia, 46010
Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009
Spain
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
United Kingdom
Sarah Cannon Research Institute UK
London, W1G 6AD
United Kingdom
The Christie NHS Foundation Trust - The Christie Clinic
Manchester, M20 4BX
United Kingdom