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RecruitingPhase 1Phase 2NCT04104776

A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas

A Phase 1/2 Study of DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas

Sponsor

Novartis Pharmaceuticals

Enrollment

300 participants

Start Date

Sep 18, 2019

Study Type

INTERVENTIONAL

Conditions

Endometrial CancerAdvanced Solid TumorDiffuse Large B Cell LymphomaMetastatic Castration-resistant Prostate CancerMesothelioma, MalignantProstatic Neoplasms, Castration-ResistantLymphoma, T-CellOvarian Clear Cell Carcinoma

Summary

The purpose of this open-label, first-in-human (FIH) trial is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of DZR123 (Tulmimetostat, CPI-0209), both as monotherapy and in combination with enzalutamide, in patients with advanced solid tumors and lymphomas.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called tulmimetostat (CPI-0209) in people with advanced cancers, including solid tumours and certain blood cancers (lymphomas). The drug works by targeting a protein involved in cancer cell growth. Different phases look at different cancer types, including bladder cancer, ovarian cancer, uterine cancer, lymphoma, mesothelioma, and prostate cancer. **You may be eligible if...** - You have an advanced or metastatic cancer that has not responded to standard treatments - For certain groups, your tumour has a specific genetic change (such as ARID1A or BAP1 mutation) - You are 18 years old or older and can be assessed for treatment response **You may NOT be eligible if...** - Your cancer has not been tested for relevant genetic mutations (for Phase 2 groups) - You do not meet the specific cancer type or prior treatment requirements for each group 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

DRUGTulmimetostat

Tulmimetostat dosed once per day orally in 28 day cycles

DRUGEnzalutamide

Enzalutamide dosed once per day orally in 28 day cycles

Locations(81)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

University of Maryland Medical Ctr

Baltimore, Maryland, United States

Massachusetts General Hospital (MGH)

Boston, Massachusetts, United States

Dana Farber Cancer Institute (HARVARD)

Boston, Massachusetts, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

NYU Langone Medical Center

New York, New York, United States

Weill Medical College of Cornell University

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Montefiore Einstein Center for Cancer Care (MECCC)

The Bronx, New York, United States

University of Cincinnati Cancer Institute

Cincinnati, Ohio, United States

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

South Texas Accelerated Research Therapeutics (START) - San Antonio

San Antonio, Texas, United States

South Texas Accelerated Research Therapeutics (START) - Midwest Location

San Antonio, Texas, United States

University of Virginia Health System (UVAHS)

Charlottesville, Virginia, United States

Swedish Cancer Institute

Seattle, Washington, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

CHU Bordeaux Hopital Saint Andre

Bordeaux, France

CLCC Institut Bergonie

Bordeaux, France

Centre Oscar Lambret

Lille, France

Centre Leon Berard

Lyon, France

CHU Nantes Hopital Hotel Dieu

Nantes, France

CHU Nantes Hopital Hotel Dieu

Nantes, France

CHU Nantes Hopital Nord Laennec

Saint-Herblain, France

Institut Cancerologie de Strasbourg

Strasbourg, France

CLCC Institut Gustave Roussy

Villejuif, France

Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi

Bologna, Italy

Fondazione IRCCS Istituto Nazionale Dei Tumori

Milan, Italy

National Cancer Institute, IRCCS

Milan, Italy

European Institute of Oncology (IEO), IRCCS ( Department of Urogenital and Head-and-Neck Medical Oncology)

Milan, Italy

European Institute of Oncology (IEO), IRCCS

Milan, Italy

Humanitas San Pio X

Milan, Italy

IRCCS Policlinico Universitario Fondazione Agostino Gemelli

Roma, Italy

IRCCS Istituto Clinico Humanitas - Research Hospital

Rozzano, Italy

Uniwersyteckie Centrum Kliniczne GUMed

Gdansk, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

Gliwice, Poland

Pratia MCM

Krakow, Poland

Institute of Polish Mother Health Centre - ICZMP

Lodz, Poland

Centrum Medyczne Pratia - Poznan

Poznan, Poland

University Teaching Hospital

Poznan, Poland

Novartis Investigative Site

Daegu, South Korea

National Cancer Center

Goyang-si Gyeonggi-do, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Seoul National University Hospital

Seoul, South Korea

Yonsei Univ Health System YUCM

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

The Catholic University of Korea, Yeouido St. Mary's Hospital

Seoul, South Korea

Hospital Vall d Hebron

Barcelona, Spain

Hospital Clinic of Barcelona

Barcelona, Spain

Catalan Institute of Oncology

Barcelona, Spain

Hospital Universitari de Girona Doctor Josep Trueta

Girona, Spain

University Hospital Ramon y Cajal

Madrid, Spain

University Hospital Clinical San Carlos, Department of Medical Oncology

Madrid, Spain

University Hospital Foundation Jimenez Diaz

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Puerta de Hierro Majadahonda University Hospital

Majadahonda, Spain

Hospital Universitario Son Espases

Palma, Spain

Clinica Universidad de Navarra

Pamplona, Spain

Clinica Universidad de Navarra

Pamplona, Spain

Hospital Universitario Quirónsalud Madrid

Pozuelo de Alarcón, Spain

Parc Taulí Hospital Universitari

Sabadell, Spain

Hematology Department - Hospital Universitario de Salamanca, IBSAL, CIBERONC

Salamanca, Spain

Santiago Clinic Hospital CHUS

Santiago de Compostela, Spain

Hospital Virgen del Rocio

Seville, Spain

Instituto Valenciano de Oncologia

Valencia, Spain

La Fe University and Polytechnic Hospital

Valencia, Spain

Royal United Hospital Bath NHS Trust

Bath, United Kingdom

Leicester General Hospital

Leicester, United Kingdom

Imperial College Healthcare NHS Trust

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Churchill Hospital

Oxford, United Kingdom

Southampton General Hospital

Southampton, United Kingdom

The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH)

Sutton, United Kingdom

The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH)

Sutton, United Kingdom

Musgrove Park Hospital

Taunton, United Kingdom

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NCT04104776

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