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 Cancer Advanced Solid Tumor Diffuse Large B Cell Lymphoma Metastatic Castration-resistant Prostate Cancer Mesothelioma, Malignant Prostatic Neoplasms, Castration-Resistant Lymphoma, T-Cell Ovarian 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(80)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan Hospitals

Ann Arbor, Michigan, United States

South Texas Accelerated Research Therapeutics (START) - Midwest Location

Grand Rapids, Michigan, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Memorial Sloan Kettering Cancer Center - NYC

New York, New York, United States

Weill Medical College of Cornell University

New York, New York, United States

University of Rochester Medical Center, James P. Wilmot Cancer Center

Rochester, New York, United States

Montefiore Medical Center, Montefiore Medical Center Laboratories

The Bronx, New York, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

University of Virginia Health System

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 Nord Laennec

Saint-Herblain, France

Hopital Hautepierre

Strasbourg, France

Gustave Roussy

Villejuif, France

Irccs University Hospital of Bologna

Bologna, Italy

National Cancer Institute, IRCCS

Milan, Italy

National Cancer Institute, IRCCS

Milan, Italy

European Institute of Oncology (IEO), IRCCS

Milan, Italy

European Institute of Oncology (IEO), IRCCS

Milan, Italy

Humanitas San Pio X

Milan, Italy

University Polyclinic Foundation "Agostino Gemelli" - IRCCS

Roma, Italy

Gruppo Humanitas - Humanitas Research Hospital - Cancer Center

Rozzano, Italy

University Teaching Centre, Early Clinical Trials Unit

Gdansk, Poland

Pratia MCM Krakow

Krakow, Poland

Polish Mother's Memorial Hospital-Research Institute

Lodz, Poland

Pratia - Poznan

Poznan, Poland

University Teaching Hospital in Poznan, Department of Gynecologic Oncology

Poznan, Poland

Maria Sklodowska-Curie - National Research Institute of Oncology

Warsaw, Poland

Keimyung University - Dongsan Medical Center

Daegu, South Korea

National Cancer Center

Goyang-si, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

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

Seoul, South Korea

University Hospital Vall d'Hebron

Barcelona, Spain

Hospital Clinic of Barcelona

Barcelona, Spain

University Hospital of Girona Dr. Josep Trueta

Girona, Spain

Catalan Institute of Oncology, Hospital Duran i Reynals

L'Hospitalet de Llobregat, Spain

University Clinic of Navarra - Madrid

Madrid, 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

University Hospital 12 de Octubre

Madrid, Spain

University Hospital Quiron Madrid

Madrid, Spain

University Hospital Puerta de Hierro Majadahonda

Majadahonda, Spain

University Hospital Son Espases

Palma, Spain

University Clinic of Navarra - Pamplona

Pamplona, Spain

Parc Tauli Health Corporation

Sabadell, Spain

University Clinical Hospital of Salamanca

Salamanca, Spain

University Hospital Complex of Santiago (CHUS)

Santiago de Compostela, Spain

University Hospital Virgen del Rocio (HUVR)

Seville, Spain

Valencia Oncology Institute (IVO)

Valencia, Spain

University and Polytechnic Hospital La Fe

Valencia, Spain

Royal United Hospital, Department of Oncology/Hematology

Bath, United Kingdom

Leicester Royal Infirmary

Leicester, United Kingdom

Royal Marsden Hospital - London

London, United Kingdom

Imperial College Healthcare NHS Trust

London, United Kingdom

The Christie NHS Foundation Trust, Department of Medical Oncology

Manchester, United Kingdom

Churchill Hospital

Oxford, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Royal Marsden Hospital - Sutton

Sutton, United Kingdom

Musgrove Park Hospital

Taunton, United Kingdom

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