RecruitingPhase 1Phase 2NCT04657068

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors


Sponsor

Artios Pharma Ltd

Enrollment

442 participants

Start Date

Jan 27, 2021

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests an experimental drug called ART0380 (alone or with other agents) in people with advanced solid tumors that have not responded to previous treatments. ART0380 targets a DNA repair pathway that many cancers depend on. **You may be eligible if...** - You are an adult with advanced or metastatic solid tumor cancer - You have stopped prior cancer treatments for at least 21 days and recovered from side effects - You have at least one tumor that can be measured by imaging - Your blood counts, kidneys, liver, and clotting function are within acceptable ranges - You have a tumor tissue sample available - Your life expectancy is at least 12 weeks **You may NOT be eligible if...** - You have not completed prior treatment washout or have unresolved serious side effects - You are pregnant or unwilling to use effective contraception - You have a BRCA mutation or HRD-positive cancer and have not yet received an approved PARP inhibitor (unless contraindicated) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGART0380

Participants will receive ART0380 by mouth either intermittently (either once daily 3 days on, 4 days off; days 2-4 and 9-11;or days 1-3 and 8-10) or continuously (once daily each day) in 21 day cycles.

DRUGGemcitabine

Gemcitabine will be administered on Days 1 and 8 of a 21-day cycle.

DRUGIrinotecan

Irinotecan will be administered as a 90-minute infusion on Days 1 and 8 of a 21 day cycle.


Locations(79)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Mayo Clinic (Arizona)

Scottsdale, Arizona, United States

University of Arkansas - Winthrop P. Rockefeller Cancer Institute

Little Rock, Arkansas, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Sansum Clinic

Santa Barbara, California, United States

Providence Medical Foundation

Santa Rosa, California, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Mayo Clinic (Florida)

Jacksonville, Florida, United States

Cancer Specialists of North Florida

Jacksonville, Florida, United States

Florida Cancer Specialists

Orlando, Florida, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Florida Cancer Specialists

West Palm Beach, Florida, United States

Hope and Healing Cancer Services

Hinsdale, Illinois, United States

Community Health Network

Indianapolis, Indiana, United States

Our Lady of the Lake

Baton Rouge, Louisiana, United States

Maryland Oncology Hematology - Primary

Columbia, Maryland, United States

Minnesota Oncology Hematology

Maple Grove, Minnesota, United States

Mayo Clinic (Minnesota)

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

Hematology Oncology Associates of Central New York

East Syracuse, New York, United States

Northwell Health Cancer Institute

Lake Success, New York, United States

Oncology Hematology Care Primary

Cincinnati, Ohio, United States

Taylor Cancer Research Center

Maumee, Ohio, United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pennsylvania / Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization

Philadelphia, Pennsylvania, United States

Tennessee Oncology, PLLC

Chattanooga, Tennessee, United States

Baptist Cancer Center

Memphis, Tennessee, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Texas Oncology - Central/South Texas

Austin, Texas, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

Texas Oncology - Northeast Texas

Flower Mound, Texas, United States

Oncology Consultants

Houston, Texas, United States

Texas Oncology - San Antonio

San Antonio, Texas, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Institut Gustave Roussy

Villejuif, Cedex, France

Institut Bergonie

Bordeau, France

Marseille University Hospital Timone

Marseille, France

Saint-Louis Hospital

Paris, France

Hospital de la Pitié-Salpêtrière

Paris, France

Hospital General Universitario de Elche

Elche, Alicante, Spain

H. Parc Tauli

Sabadell, Barcelona, Spain

Next Oncology Barcelona, IOB

Barcelona, Catalonia, Spain

Hospital Arnau de Vilanova

Lleida, Catalonia, Spain

Hospital Universitario La Paz

Madrid, Madrid, Spain

Next - Hospital Quironsalud Madrid

Pozuelo de Alarcón, Madrid, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Clínica Universidad de Navarra

Madrid, Planta -2, Spain

Hospital Clínico Universitario de Santiago (CHUS)

A Coruña, Spain

Hospital Teresa Herrera (CHUAC)

A Coruña, Spain

Institut Català d'Oncologia Badalona - Hospital Germans Trias i Pujol

Badalona, Spain

Vall d'Hebron Institute of Oncology (VIHO)

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

ICO Hospitalet

Barcelona, Spain

Hospital Universitario Reina Sofia de Córdoba

Córdoba, Spain

Hospital Universitari Doctor Josep Trueta- ICO de Girona

Girona, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

MD Anderson Cancer Center (Madrid

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

START Madrid Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

START Madrid (Hospital San Chinarro)

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital Universitario De Navarra

Pamplona, Spain

START Rioja

Rioja, Spain

Hospital Virgen Macarena

Seville, Spain

Hospital Virgen del Rocío

Seville, Spain

Instituto Valenciano de Oncología (IVO)

Valencia, Spain

Incliva Biomedical Research Institute, University of Valencia

Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Sarah Cannon Research Institute UK

London, United Kingdom

The Christie NHS Foundation Trust - The Christie Clinic

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04657068


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