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New pill aims to shrink Hard-to-Treat cancers

NCT ID NCT04104776

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This study tests an experimental drug called Tulmimetostat (DZR123) in people with advanced solid tumors or lymphomas that have not improved with standard treatments. The drug is taken as a daily pill, either alone or combined with another drug (enzalutamide) for certain prostate cancers. The goal is to find a safe dose and see if the drug can shrink tumors or slow cancer growth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tulmimetostat (also known as DZR123 or CPI-0209)
What this could lead to
If successful, this could provide a new treatment option for people with advanced solid tumors or lymphomas that have not responded to other therapies.
What could go wrong
This is an early-phase trial, so the drug may not prove effective or may cause significant side effects. Results may not apply to all cancer types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2019

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: All Patients: * Adults aged ≥18 years with life expectancy ≥12 weeks * ECOG performance status 0-1 * Adequate recovery from prior therapy-related toxicities (Grade ≤1, with exceptions) * Adequate bone marrow, renal, and hepatic function per protocol-defined thresholds * Willingness to provide tumor tissue and blood samples for biomarker analyses * Agreement to protocol-specified contraception requirements * Signed informed consent prior to study procedures Disease-Specific Inclusion Criteria: Phase 1 (Dose Escalation): * Histologically or cytologically confirmed locally advanced or metastatic solid tumors or lymphoma * Disease refractory to standard therapy or with no available effective standard treatment * For prostate cancer: castrate testosterone levels maintained throughout the study Phase 2 (Disease-Specific Cohorts): * M1: ARID1A mutant urothelial carcinoma or other ARID1A mutant solid tumors (with cohort specific prior therapy and RECIST 1.1 measurable disease requirements) * M2: ARID1A mutant ovarian clear cell carcinoma after prior platinum-based therapy (and bevacizumab unless contraindicated) * M3: ARID1A mutant recurrent/metastatic endometrial carcinoma after platinum therapy and appropriate immunotherapy * M4: Relapsed/refractory peripheral T cell lymphoma or diffuse large B cell lymphoma, transplant-ineligible, with measurable disease * M5: Relapsed/refractory pleural or peritoneal mesothelioma with documented BAP1 loss * M6: Metastatic castration-resistant prostate cancer (mCRPC) with documented progression after AR targeted therapy and taxane chemotherapy * M7: ARID1A wild type endometrial carcinoma (exploratory food-effect cohort) * M8: mCRPC treated with DZR123 in combination with enzalutamide, with cohort specific requirements for prior androgen receptor pathway inhibitor and chemotherapy exposure Key Exclusion Criteria: All Patients: Medical Conditions: * Prior solid organ or allogeneic hematopoietic cell transplant * Active or untreated symptomatic CNS metastases (with limited exceptions) * Clinically significant cardiovascular disease, including uncontrolled arrhythmias or prolonged QTc * Active interstitial lung disease or pneumonitis * Uncontrolled infections or significant gastrointestinal disorders affecting absorption * Active HIV or hepatitis B/C infection * Concurrent malignancy requiring active treatment (with protocol-defined exceptions) * Pregnancy, breastfeeding, or inability to comply with protocol requirements Prior or Concomitant Therapy: * Recent anticancer therapy within protocol-defined washout periods * Prior EZH2 inhibitor treatment * Recent radiation or liver-directed therapies outside allowed windows * Use of strong CYP3A4/5 inhibitors or inducers Additional Cohort-Specific Exclusions: * M6 (mCRPC): Bone-only disease, unstable bone lesions, PSA-lowering herbal products, recent prohibited prostate cancer therapies * M8 (Combination): PSA-only disease, prior investigational androgen receptor pathway inhibitors, significant seizure risk, extensive prior bone marrow irradiation, active inflammatory gastrointestinal disease

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Conditions

The condition(s) this trial relates to.

B-cell neoplasm castration-resistant prostate carcinoma diffuse large B-cell lymphoma endometrial cancer endometrial carcinoma endometrium neoplasm immune system disorder immunoproliferative disorder lymphatic system disorder lymphoma lymphoproliferative syndrome malignant mesothelioma mature T-cell and NK-cell non-Hodgkin lymphoma Mesothelioma, Malignant neoplasm Neoplasms by Histologic Type Neoplasms by Site non-Hodgkin lymphoma ovarian clear cell cancer Prostatic Neoplasms, Castration-Resistant T-cell non-Hodgkin lymphoma urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Diffuse large B-cell lymphoma Endometrial cancer Lymphoma, T-cell Mesothelioma, malignant Metastatic castration resistant prostate cancer Ovarian clear cell carcinoma Prostatic neoplasms, castration-resistant

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    43 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Abramson Cancer Center of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • CHU Bordeaux Hopital Saint Andre

    WITHDRAWN

    Bordeaux, 33000, France

  • CHU Nantes Hopital Hotel Dieu

    RECRUITING

    Nantes, 44093 Cedex 1, France

  • CHU Nantes Hopital Nord Laennec

    RECRUITING

    Saint-Herblain, 44800, France

  • CLCC Institut Bergonie

    RECRUITING

    Bordeaux, 33000, France

  • Catalan Institute of Oncology, Hospital Duran i Reynals

    WITHDRAWN

    L'Hospitalet de Llobregat, 08908, Spain

  • Centre Leon Berard

    RECRUITING

    Lyon, 69008, France

  • Centre Oscar Lambret

    RECRUITING

    Lille, 59000, France

  • Churchill Hospital

    WITHDRAWN

    Oxford, OX3 7LE, United Kingdom

  • Dana Farber Cancer Institute

    COMPLETED

    Boston, Massachusetts, 02215-5450, United States

  • European Institute of Oncology (IEO), IRCCS

    COMPLETED

    Milan, 20141, Italy

  • European Institute of Oncology (IEO), IRCCS

    RECRUITING

    Milan, 20141, Italy

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109-1023, United States

  • Gachon University Gil Medical Center

    RECRUITING

    Incheon, 21565, South Korea

  • Gangnam Severance Hospital

    RECRUITING

    Seoul, 06273, South Korea

  • Gruppo Humanitas - Humanitas Research Hospital - Cancer Center

    RECRUITING

    Rozzano, 20089, Italy

  • Gustave Roussy

    RECRUITING

    Villejuif, 94805 Cedex, France

  • H. Lee Moffitt Cancer Center & Research Institute

    WITHDRAWN

    Tampa, Florida, 33612, United States

  • Hackensack University Medical Center

    COMPLETED

    Hackensack, New Jersey, 07601, United States

  • Hopital Hautepierre

    RECRUITING

    Strasbourg, 67098, France

  • Hospital Clinic of Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Humanitas San Pio X

    RECRUITING

    Milan, 20159, Italy

  • Imperial College Healthcare NHS Trust

    WITHDRAWN

    London, SW7 2AZ, United Kingdom

  • Irccs University Hospital of Bologna

    COMPLETED

    Bologna, 40138, Italy

  • Keimyung University - Dongsan Medical Center

    WITHDRAWN

    Daegu, 42601, South Korea

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    COMPLETED

    New York, New York, 10016, United States

  • Leicester Royal Infirmary

    RECRUITING

    Leicester, LE1 5WW, United Kingdom

  • Loyola University Medical Center

    WITHDRAWN

    Maywood, Illinois, 60153, United States

  • Maria Sklodowska-Curie - National Research Institute of Oncology

    COMPLETED

    Warsaw, 02-781, Poland

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center - NYC

    WITHDRAWN

    New York, New York, 10065, United States

  • Montefiore Medical Center, Montefiore Medical Center Laboratories

    WITHDRAWN

    The Bronx, New York, 10467-2490, United States

  • Musgrove Park Hospital

    COMPLETED

    Taunton, TA1 5DA, United Kingdom

  • National Cancer Center

    COMPLETED

    Goyang-si, 10408, South Korea

  • National Cancer Institute, IRCCS

    RECRUITING

    Milan, 20133, Italy

  • National Cancer Institute, IRCCS

    WITHDRAWN

    Milan, 20133, Italy

  • Parc Tauli Health Corporation

    RECRUITING

    Sabadell, 08208, Spain

  • Polish Mother's Memorial Hospital-Research Institute

    WITHDRAWN

    Lodz, 93-338, Poland

  • Pratia - Poznan

    COMPLETED

    Poznan, 60-192, Poland

  • Pratia MCM Krakow

    WITHDRAWN

    Krakow, 30-510, Poland

  • Roswell Park Cancer Institute

    WITHDRAWN

    Buffalo, New York, 14263-0001, United States

  • Royal Marsden Hospital - London

    WITHDRAWN

    London, SW3 6JJ, United Kingdom

  • Royal Marsden Hospital - Sutton

    COMPLETED

    Sutton, SM2 5PT, United Kingdom

  • Royal United Hospital, Department of Oncology/Hematology

    WITHDRAWN

    Bath, BA1 3NG, United Kingdom

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • South Texas Accelerated Research Therapeutics

    COMPLETED

    San Antonio, Texas, 78229, United States

  • South Texas Accelerated Research Therapeutics (START) - Midwest Location

    ACTIVE_NOT_RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • Swedish Cancer Institute

    RECRUITING

    Seattle, Washington, 98104, United States

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

    WITHDRAWN

    Seoul, 06591, South Korea

  • The Christie NHS Foundation Trust, Department of Medical Oncology

    COMPLETED

    Manchester, M20 4BX, United Kingdom

  • University Clinic of Navarra - Madrid

    RECRUITING

    Madrid, 28027, Spain

  • University Clinic of Navarra - Pamplona

    RECRUITING

    Pamplona, 31008, Spain

  • University Clinical Hospital of Salamanca

    COMPLETED

    Salamanca, 37007, Spain

  • University Hospital 12 de Octubre

    COMPLETED

    Madrid, 28041, Spain

  • University Hospital Clinical San Carlos, Department of Medical Oncology

    RECRUITING

    Madrid, 28040, Spain

  • University Hospital Complex of Santiago (CHUS)

    RECRUITING

    Santiago de Compostela, 15706, Spain

  • University Hospital Foundation Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • University Hospital Puerta de Hierro Majadahonda

    RECRUITING

    Majadahonda, 28222, Spain

  • University Hospital Quiron Madrid

    RECRUITING

    Madrid, 28223, Spain

  • University Hospital Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • University Hospital Son Espases

    RECRUITING

    Palma, 07120, Spain

  • University Hospital Southampton NHS Foundation Trust

    WITHDRAWN

    Southampton, SO16 6YD, United Kingdom

  • University Hospital Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • University Hospital Virgen del Rocio (HUVR)

    RECRUITING

    Seville, 41013, Spain

  • University Hospital of Girona Dr. Josep Trueta

    RECRUITING

    Girona, 17007, Spain

  • University Polyclinic Foundation "Agostino Gemelli" - IRCCS

    RECRUITING

    Roma, 00168, Italy

  • University Teaching Centre, Early Clinical Trials Unit

    RECRUITING

    Gdansk, 80-214, Poland

  • University Teaching Hospital in Poznan, Department of Gynecologic Oncology

    RECRUITING

    Poznan, 60-569, Poland

  • University and Polytechnic Hospital La Fe

    RECRUITING

    Valencia, 46026, Spain

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Cincinnati Medical Center

    WITHDRAWN

    Cincinnati, Ohio, 45219, United States

  • University of Maryland Greenebaum Cancer Center

    WITHDRAWN

    Baltimore, Maryland, 21201, United States

  • University of Michigan Hospitals

    WITHDRAWN

    Ann Arbor, Michigan, 48109, United States

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

    WITHDRAWN

    Rochester, New York, 14642, United States

  • University of Virginia Health System

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Valencia Oncology Institute (IVO)

    RECRUITING

    Valencia, 46009, Spain

  • Weill Medical College of Cornell University

    WITHDRAWN

    New York, New York, 10065, United States

  • Winship Cancer Institute of Emory University

    RECRUITING

    Atlanta, Georgia, 30322-1013, United States

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