RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Novartis Pharmaceuticals • ClinicalTrials.gov ID: NCT04104776

Registry updated: 2026-08-19

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Description

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.

Interventions

Tulmimetostat (Drug)
Tulmimetostat dosed once per day orally in 28 day cycles
Enzalutamide (Drug)
Enzalutamide dosed once per day orally in 28 day cycles

Eligibility criteria

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

Conditions

Advanced Solid Tumor Diffuse Large B Cell Lymphoma Lymphoma, T-Cell Mesothelioma, Malignant Prostatic Neoplasms, Castration-Resistant Endometrial Cancer Ovarian Clear Cell Carcinoma Metastatic Castration-resistant Prostate Cancer

Locations

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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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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