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Clinical Trials in the USA / NCT04104776
Recruiting Phase 1/2

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

NCT04104776 · tracked via the Priya Life Science USA tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 1/2
Started
2019-09-18
Last updated
2026-08-19

Condition(s) studied

Advanced Solid TumorDiffuse Large B Cell LymphomaLymphoma, T-CellMesothelioma, MalignantProstatic Neoplasms, Castration-ResistantEndometrial CancerOvarian Clear Cell CarcinomaMetastatic Castration-resistant Prostate Cancer

Investigational drug(s) / intervention(s)

TulmimetostatEnzalutamide

Tulmimetostat: Tulmimetostat dosed once per day orally in 28 day cycles

Enzalutamide: Enzalutamide dosed once per day orally in 28 day cycles

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (80)

FacilityCityRegionStatus
H. Lee Moffitt Cancer Center & Research Institute Tampa Florida Withdrawn
Winship Cancer Institute of Emory University Atlanta Georgia Recruiting
University of Chicago Medical Center Chicago Illinois Recruiting
Loyola University Medical Center Maywood Illinois Withdrawn
University of Maryland Greenebaum Cancer Center Baltimore Maryland Withdrawn
Massachusetts General Hospital Boston Massachusetts Recruiting
Dana Farber Cancer Institute Boston Massachusetts Completed
University of Michigan Hospitals Ann Arbor Michigan Withdrawn
South Texas Accelerated Research Therapeutics (START) - Midwest Location Grand Rapids Michigan Active Not Recruiting
Hackensack University Medical Center Hackensack New Jersey Completed
Roswell Park Cancer Institute Buffalo New York Withdrawn
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York Completed
Memorial Sloan Kettering Cancer Center - NYC New York New York Withdrawn
Weill Medical College of Cornell University New York New York Withdrawn
University of Rochester Medical Center, James P. Wilmot Cancer Center Rochester New York Withdrawn
Montefiore Medical Center, Montefiore Medical Center Laboratories The Bronx New York Withdrawn
University of Cincinnati Medical Center Cincinnati Ohio Withdrawn
Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania Recruiting
South Texas Accelerated Research Therapeutics San Antonio Texas Completed
University of Virginia Health System Charlottesville Virginia Recruiting
Swedish Cancer Institute Seattle Washington Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
CHU Bordeaux Hopital Saint Andre Bordeaux France Withdrawn
CLCC Institut Bergonie Bordeaux France Recruiting
Centre Oscar Lambret Lille France Recruiting
Centre Leon Berard Lyon France Recruiting
CHU Nantes Hopital Hotel Dieu Nantes France Recruiting
CHU Nantes Hopital Nord Laennec Saint-Herblain France Recruiting
Hopital Hautepierre Strasbourg France Recruiting
Gustave Roussy Villejuif France Recruiting
Irccs University Hospital of Bologna Bologna Italy Completed
National Cancer Institute, IRCCS Milan Italy Recruiting
National Cancer Institute, IRCCS Milan Italy Withdrawn
European Institute of Oncology (IEO), IRCCS Milan Italy Completed
European Institute of Oncology (IEO), IRCCS Milan Italy Recruiting
Humanitas San Pio X Milan Italy Recruiting
University Polyclinic Foundation "Agostino Gemelli" - IRCCS Roma Italy Recruiting
Gruppo Humanitas - Humanitas Research Hospital - Cancer Center Rozzano Italy Recruiting
University Teaching Centre, Early Clinical Trials Unit Gdansk Poland Recruiting
Pratia MCM Krakow Krakow Poland Withdrawn

+ 40 more sites — see the full list on the official registry below.

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04104776 on ClinicalTrials.gov ↗ ← All trials in the USA