ClinicalTrials.gg
RecruitingNCT04104776Updated Aug 19, 2026

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

A Phase 1/2 interventional study of Tulmimetostat and Enzalutamide in Advanced Solid Tumor, Diffuse Large B Cell Lymphoma and Lymphoma, T-Cell, sponsored by Novartis Pharmaceuticals. Recruiting at 80 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2019; still recruiting 7 years 1 month later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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.

Read the detailed description

This study consists of Phase 1 dose-escalation and Phase 2 dose-expansion cohorts designed to characterize DZR123 across multiple tumor-specific populations and to identify dose levels for further clinical development. Phase 2 includes disease-specific monotherapy cohorts, dose-optimization cohorts, a food-effect cohort, and a combination cohort evaluating DZR123 with enzalutamide in metastatic castration-resistant prostate cancer. The study also includes long-term follow-up to monitor survival and the occurrence of second primary malignancies, with assessments conducted approximately every 3 months for the first 3 years and every 6 months thereafter.

Phase 1: Dose Escalation (Monotherapy) The initial phase of the study consists of a dose-escalation period using a traditional 3+3 design. Adult patients with advanced, relapsed, or refractory solid tumors or lymphomas receive escalating doses of DZR123 as monotherapy. The primary objective of this phase is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of DZR123. Dose-escalation decisions are based on safety, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary antitumor activity data. Patients are not randomized during this phase.

Phase 2: Dose Expansion and Optimization Phase 2 further evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of DZR123 in disease-specific cohorts and explores dose optimization and combination therapy approaches.

Cohorts M1-M6: Disease-Specific Monotherapy Patients are enrolled into disease-specific cohorts defined by tumor type and/or molecular characteristics, including adenine-thymine-rich interactive domain-containing protein 1A (ARID1A) mutations, BRCA1-associated protein 1 (BAP1) loss, lymphoma subtypes, and metastatic castration-resistant prostate cancer (mCRPC).

Cohorts M1, M5, and M6 use a Simon's two-stage design in which 10 patients are enrolled in Stage 1; if at least 1 response is observed, up to 19 additional patients are enrolled in Stage 2. Cohorts M2 and M3 also begin with a Simon's two-stage design and subsequently transition into dose-optimization stages. Cohort M4 enrolls approximately 20 patients with lymphoma in a single stage without further expansion. Patients are not randomized except during dose-optimization stages in Cohorts M2 and M3.

Dose Optimization in Cohorts M2 and M3 For ovarian clear cell carcinoma (Cohort M2) and endometrial carcinoma (Cohort M3), dose optimization is conducted after initial cohort expansion. In Stage 2a, participants are randomized 1:1 to receive DZR123 200 mg or 300 mg once daily. Depending on predefined efficacy and safety criteria, Stage 2b may enroll additional participants in one or both dose groups to further evaluate the optimal dose for future clinical development.

Cohort M7: Food-Effect Evaluation Cohort M7 evaluates the effect of a high-fat, high-calorie meal on the pharmacokinetics of DZR123 in patients with ARID1A wild-type endometrial carcinoma. Approximately 20 participants receive a single dose of DZR123 with a standardized meal on Cycle 1 Day 1, followed by continued DZR123 administration. Results from this cohort may inform future administration instructions regarding food intake in subsequent DZR123 studies and cohorts.

Cohort M8: DZR123 in Combination With Enzalutamide Cohort M8 evaluates DZR123 in combination with enzalutamide in participants with metastatic castration-resistant prostate cancer and consists of two parts.

  • Part 1 (Dose Escalation): Participants receive escalating doses of DZR123 in combination with enzalutamide 160 mg once daily. Dose escalation is guided by a Bayesian logistic regression model (BLRM) using the Escalation With Overdose Control (EWOC) principle to determine the RP2D for the combination. Approximately 30 participants are enrolled. A 7-day enzalutamide run-in period may be used prior to combination treatment.
  • Part 2 (Dose Expansion): Following selection of the RP2D, approximately 40 additional participants receive DZR123 at the selected dose in combination with enzalutamide to further evaluate safety, tolerability, PK, PD, and antitumor activity. Amendment 15 increased the planned enrollment in Part 2 from approximately 15 to approximately 40 participants and revised the primary efficacy assessment to focus on prostate-specific antigen response.

The study includes safety monitoring throughout treatment and follow-up, including collection of adverse events, laboratory assessments, tumor evaluations, and dedicated surveillance for second primary malignancies associated with EZH1/2 inhibition.

02

Conditions studied

  • 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

Keywords

  • Tulmimetostat
  • DZR123
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, B-cell
  • Lymphoma, T-cell
  • Lymphoma, Non-Hodgkin
  • Lymphoma
  • Neoplasms by Site
  • Neoplasms by Histologic Type
  • Neoplasms
  • Lymphoproliferative Disorders
  • Lymphatic Diseases
  • Immunoproliferative Disorders
  • Immune System Diseases
  • Topoisomerase Inhibitors
  • Molecular Mechanisms of Pharmacological Action
  • Antineoplastic Agents
  • Endometrial Cancer
  • Ovarian Clear Cell Carcinoma
  • Food effect
  • Adenine-thymine (AT)-rich interactive domain-containing protein 1A (ARID1A)
  • ARID1A wildtype (ARID1A WT) endometrial carcinoma
  • Metastatic castration-resistant prostate cancer (mCRPC)
03

In context

Lymphoma, Large B-Cell, Diffuse

1,868 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 355 are open to participants now.

This study's planned enrollment of 300 is above the median of 45 across 1,497 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.

Browse Lymphoma, Large B-Cell, Diffuse studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.

Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

All Patients:

  • Adults aged ≥18 years with ≥12 weeks
  • 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 requirements
  • Signed prior to study procedures

Disease-Specific Inclusion Criteria:

Phase 1 (Dose Escalation):

  • or cytologically confirmed locally advanced or solid tumors or lymphoma
  • Disease 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 1.1 requirements)
  • M2: ARID1A mutant ovarian clear cell carcinoma after prior platinum-based therapy (and bevacizumab unless )
  • 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 hematopoietic cell transplant
  • Active or untreated symptomatic (with limited exceptions)
  • cardiovascular disease, including uncontrolled arrhythmias or prolonged
  • Active interstitial lung disease or pneumonitis
  • Uncontrolled infections or significant gastrointestinal disorders affecting absorption
  • Active or /C infection
  • Concurrent 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
  • Prior EZH2 inhibitor treatment
  • Recent radiation or liver-directed therapies outside allowed windows
  • Use of strong /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 androgen receptor pathway inhibitors, significant seizure risk, extensive prior bone marrow irradiation, active inflammatory gastrointestinal disease
Terms in these criteria, in plain language(20)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Phase 1

    Eligible participants with advanced tumors will receive escalating doses of Tulmimetostat once per day orally.

    Drug: Tulmimetostat

  • Experimental
    Phase 2 - Cohort M1 (Advanced/metastatic solid tumors or urothelial carcinoma with ARID1A mutation)

    Eligible participants with advanced/metastatic solid tumors (excluding ovarian clear cell and endometrial carcinoma) or urothelial carcinoma, confirmed to have ARID1A mutations will receive oral Tulmimetostat once daily in 28-day treatment cycles.

    Drug: Tulmimetostat

  • Experimental
    Phase 2 - Cohort M2 (Ovarian clear cell carcinoma with ARID1A mutation)

    Eligible participants with advanced ovarian clear cell carcinoma, confirmed to have ARID1A mutations, who have received prior platinum-based chemotherapy will receive oral Tulmimetostat once daily in 28-day treatment cycles.

    Drug: Tulmimetostat

  • Experimental
    Phase 2 - Cohort M3 (Endometrial carcinoma with ARID1A mutation)

    Eligible participants with recurrent, metastatic, or unresectable endometrial carcinoma, confirmed to have ARID1A mutations, and prior platinum-based therapy will receive oral Tulmimetostat once daily in 28-day treatment cycles.

    Drug: Tulmimetostat

  • Experimental
    Phase 2 - Cohort M4 (Relapsed/refractory lymphoma (PTCL or DLBCL))

    Eligible participants with relapsed or refractory peripheral T-cell lymphoma (PTCL) or diffuse large B-cell lymphoma (DLBCL), including those with EZH2 hotspot mutations will receive oral Tulmimetostat once daily in 28-day treatment cycles.

    Drug: Tulmimetostat

  • Experimental
    Phase 2 - Cohort M5 (Malignant mesothelioma with BAP1 loss)

    Eligible participants with relapsed or refractory malignant pleural or peritoneal mesothelioma, confirmed to have BAP1 loss will receive oral Tulmimetostat once daily in 28-day treatment cycles.

    Drug: Tulmimetostat

  • Experimental
    Phase 2 - Cohort M6 (Metastatic castration-resistant prostate cancer (mCRPC))

    Eligible participants with mCRPC, measurable soft tissue disease, and prior treatment with at least one androgen receptor signaling inhibitor and one taxane-based chemotherapy will receive oral Tulmimetostat once daily in 28-day treatment cycles.

    Drug: Tulmimetostat

  • Experimental
    Phase 2 - Cohort M7 (Food effect in ARID1A wildtype endometrial carcinoma)

    Eligible participants with recurrent, advanced endometrial carcinoma that is ARID1A wildtype (no ARID1A mutation), to evaluate the effect of food on DZR123 pharmacokinetics will receive oral Tulmimetostat once daily in 28-day treatment cycles.

    Drug: Tulmimetostat

  • Experimental
    Cohort M8 - Part 1 (Tulmimetostat + enzalutamide in mCRPC)

    Eligible participants with mCRPC receive DZR123 in combination with enzalutamide. Part 1 is dose escalation to determine the recommended dose.

    Drug: Tulmimetostat

  • Experimental
    Cohort M8 - Part 2 (Tulmimetostat + enzalutamide in mCRPC)

    Eligible participants with mCRPC receive DZR123 in combination with enzalutamide. Part 2 is expansion at the selected dose to further assess safety and antitumor activity.

    Drug: Tulmimetostat · Drug: Enzalutamide

Interventions

  • Tulmimetostat dosed once per day orally in 28 day cycles

    Also known as: DZR123

  • Enzalutamide dosed once per day orally in 28 day cycles

06

What researchers measure

Primary outcomes

  1. Tulmimetostat Monotherapy Phase 1: Frequency of Dose-limiting toxicities (DLTs)

    The maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of Tulmimetostat as monotherapy in patients with advanced tumors.

    Time frame: DLTs assessed during Cycle 1 (cycle = 28 days)

  2. Tulmimetostat Monotherapy Phase 2: Overall response rate (ORR)

    ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) based on RECIST 1.1 or applicable response criteria

    Time frame: Up to 30 months

  3. Cohort M8 Part 1: Frequency of Dose-limiting toxicities (DLTs)

    The maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of Tulmimetostat in combination with enzalutamide in patients with castration-resistant prostate cancer (mCRPC) with measurable soft tissue disease.

    Time frame: DLTs assessed during Cycle 1 (cycle = 28 days)

  4. Cohort M8 Part 2: Prostate-Specific Antigen 50 (PSA50) Response

    Prostate-Specific Antigen 50 (PSA50) is defined as a ≥ 50% decrease in PSA levels from baseline at any timepoint, confirmed by a second PSA measurement ≥ 3 weeks without any PSA progression in between

    Time frame: Up to 30 months

Secondary outcomes

  1. Tulmimetostat Monotherapy (Phase 1 & 2) and Cohort M8 (Parts 1 & 2): Incidence Rate of Adverse Events (AEs)

    Number of Participants With Adverse Events (AEs)

    Time frame: Up to 18 months

  2. Tulmimetostat Monotherapy (Phase 1 & 2), Cohort M7 and Cohort M8 (Parts 1 & 2): Maximum observed plasma concentration (Cmax)

    Venous whole blood samples will be collected for pharmacokinetics characterization. Cmax of Tulmimetostat will be listed and summarized using descriptive statistics.

    Time frame: Up to 18 months

  3. Tulmimetostat Monotherapy (Phase 1 & 2), Cohort M7 and Cohort M8 (Parts 1 & 2): Time of maximum observed plasma concentration (Tmax)

    Venous whole blood samples will be collected for pharmacokinetics characterization. Tmax of Tulmimetostat will be listed and summarized using descriptive statistics.

    Time frame: Up to 18 months

  4. Tulmimetostat Monotherapy (Phase 1 & 2), Cohort M7 and Cohort M8 (Parts 1 & 2): Area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-last)

    Venous whole blood samples will be collected for pharmacokinetics characterization. AUC0-last of Tulmimetostat will be listed and summarized using descriptive statistics.

    Time frame: Up to 18 months

  5. Tulmimetostat Monotherapy (Phase 1 & 2), Cohort M7 and Cohort M8 (Parts 1 & 2): Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-Inf)

    Venous whole blood samples will be collected for pharmacokinetics characterization. AUC0-Inf of Tulmimetostat will be listed and summarized using descriptive statistics.

    Time frame: Up to 18 months

  6. Tulmimetostat Monotherapy (Phase 1 & 2) and Cohort M7: Terminal elimination half-life (T1/2)

    Venous whole blood samples will be collected for pharmacokinetics characterization. T 1/2 of Tulmimetostat will be listed and summarized using descriptive statistics.

    Time frame: Up to 18 months

  7. Tulmimetostat Monotherapy (Phase 1 & 2), Cohort M7 and Cohort M8 (Parts 1 & 2): Plasma concentrations prior to the next dose-trough (Cmin)

    Venous whole blood samples will be collected for pharmacokinetics characterization. Cmin of Tulmimetostat will be listed and summarized using descriptive statistics.

    Time frame: Up to 18 months

  8. Tulmimetostat Monotherapy (Phase 1) and Cohort M8 (Part 1): Objective Response Rate (ORR)

    ORR defined as proportion of patients with a best overall response of complete response (CR) or partial response (PR), per Investigator assessment based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1 or applicable response criteria)

    Time frame: Up to 30 months

  9. Tulmimetostat Monotherapy (Phase 1 & 2): ORR per Gynecologic Cancer Intergroup (GCIG)

    ORR per Gynecologic Cancer Intergroup (GCIG)-defined CA-125 response criteria (ovarian cancer patients)

    Time frame: Up to 30 months

  10. Tulmimetostat Monotherapy (Phase 1): ORR per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)

    ORR per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) (in Phase 1 prostate cancer patients only)

    Time frame: Up to 30 months

  11. Tulmimetostat Monotherapy (Phase 1 & 2) and Cohort M8 (Part 2): Progression-free survival (PFS)

    PFS defined as the time from first dose to confirmed disease progression or death

    Time frame: Up to 30 months

  12. Tulmimetostat Monotherapy (Phase 1 & 2) and Cohort M8 (Parts 1 & 2): Duration of response (DOR)

    DOR defined as the time from the date of first response to the date of confirmed disease progression

    Time frame: Up to 30 months

  13. Tulmimetostat Monotherapy (Phase 1 & 2): Time to response (TTR)

    TTR defined as the time from first dose to date of first response

    Time frame: Up to 30 months

  14. Tulmimetostat Monotherapy (Phase 1 & 2) and Cohort M8 (Part 1): Disease Control Rate (DCR)

    DCR defined as the proportion of patients with a best overall response of CR, PR, or stable disease (SD)

    Time frame: Up to 30 months

  15. Tulmimetostat Monotherapy Phase 2: Time-to-progression (TTP)

    TTP defined as duration from the start of treatment until the disease progression

    Time frame: Up to 30 months

  16. Tulmimetostat Monotherapy (Phase 2) and Cohort M8 (Part 2): Overall survival (OS)

    OS defined as the time from first dose to death

    Time frame: Up to 30 months

  17. Cohort M8 Part 1: Prostate-Specific Antigen 50 (PSA50) Response

    PSA50 response defined as PSA decline by \>=50% from baseline

    Time frame: Up to 18 months

  18. Cohort M8 Part 1: Number of participants experiencing Dose-limiting toxicities (DLTs)

    To establish dose-toxicity relationship between Tulmimetostat and enzalutamide combination

    Time frame: DLTs assessed during Cycle 1 (cycle = 28 days)

  19. Cohort M8 Part 2: Time to Prostate-Specific Antigen (PSA) Progression

    Time to PSA progression defined as the time from first dose to PSA progression

    Time frame: Up to 18 months

07

Study locations

43 of 80 sites recruiting
  • H. Lee Moffitt Cancer Center & Research Institute
    Tampa, Florida 33612, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Winship Cancer Institute of Emory University
    Atlanta, Georgia 30322-1013, United States
    Recruiting
    • Beryl Manning-Geist, MD · Principal investigator
  • University of Chicago Medical Center
    Chicago, Illinois 60637, United States
    Recruiting
    • Hedy Lee Kindler, MD · Principal investigator
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • University of Maryland Greenebaum Cancer Center
    Baltimore, Maryland 21201, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
    Recruiting
    • Ryan Sullivan, MD · Principal investigator
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02215-5450, United States
    Completed

    Not enrolling at this site — choose another above.

  • University of Michigan Hospitals
    Ann Arbor, Michigan 48109, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • South Texas Accelerated Research Therapeutics (START) - Midwest Location
    Grand Rapids, Michigan 49546, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
    Completed

    Not enrolling at this site — choose another above.

  • Roswell Park Cancer Institute
    Buffalo, New York 14263-0001, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone
    New York, New York 10016, United States
    Completed

    Not enrolling at this site — choose another above.

  • Memorial Sloan Kettering Cancer Center - NYC
    New York, New York 10065, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Weill Medical College of Cornell University
    New York, New York 10065, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • University of Rochester Medical Center, James P. Wilmot Cancer Center
    Rochester, New York 14642, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Montefiore Medical Center, Montefiore Medical Center Laboratories
    The Bronx, New York 10467-2490, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • University of Cincinnati Medical Center
    Cincinnati, Ohio 45219, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Abramson Cancer Center of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
    Recruiting
    • Lainie Martin, MD · Principal investigator
  • South Texas Accelerated Research Therapeutics
    San Antonio, Texas 78229, United States
    Completed

    Not enrolling at this site — choose another above.

  • University of Virginia Health System
    Charlottesville, Virginia 22908, United States
    Recruiting
    • Linda Duska, MD · Principal investigator
  • Swedish Cancer Institute
    Seattle, Washington 98104, United States
    Recruiting
    • Charles Drescher, MD · Principal investigator
  • Fred Hutchinson Cancer Center
    Seattle, Washington 98109-1023, United States
    Recruiting
    • Kalyan Banda, MD · Principal investigator
  • CHU Bordeaux Hopital Saint Andre
    Bordeaux, 33000, France
    Withdrawn

    Not enrolling at this site — choose another above.

  • CLCC Institut Bergonie
    Bordeaux, 33000, France
    Recruiting
    • Antoine Italiano · Principal investigator
  • Centre Oscar Lambret
    Lille, 59000, France
    Recruiting
    • Cyril Abdeddaim · Principal investigator
  • Centre Leon Berard
    Lyon, 69008, France
    Recruiting
    • Medhi Brahmi · Principal investigator
  • CHU Nantes Hopital Hotel Dieu
    Nantes, 44093 Cedex 1, France
    Recruiting
    • Caroline Viala · Principal investigator
  • CHU Nantes Hopital Nord Laennec
    Saint-Herblain, 44800, France
    Recruiting
    • Caroline Viala · Principal investigator
  • Hopital Hautepierre
    Strasbourg, 67098, France
    Recruiting
    • Lauriane Eberst · Principal investigator
  • Gustave Roussy
    Villejuif, 94805 Cedex, France
    Recruiting
    • Vincent Ribrag · Principal investigator
  • Irccs University Hospital of Bologna
    Bologna, 40138, Italy
    Completed

    Not enrolling at this site — choose another above.

  • National Cancer Institute, IRCCS
    Milan, 20133, Italy
    Recruiting
    • Mara Mantiero · Principal investigator
  • National Cancer Institute, IRCCS
    Milan, 20133, Italy
    Withdrawn

    Not enrolling at this site — choose another above.

  • European Institute of Oncology (IEO), IRCCS
    Milan, 20141, Italy
    Completed

    Not enrolling at this site — choose another above.

  • European Institute of Oncology (IEO), IRCCS
    Milan, 20141, Italy
    Recruiting
    • Franco Nole · Principal investigator
  • Humanitas San Pio X
    Milan, 20159, Italy
    Recruiting
    • Domenica Lorusso · Principal investigator
  • University Polyclinic Foundation "Agostino Gemelli" - IRCCS
    Roma, 00168, Italy
    Recruiting
    • Vanda Salutari · Principal investigator
  • Gruppo Humanitas - Humanitas Research Hospital - Cancer Center
    Rozzano, 20089, Italy
    Recruiting
    • Carmelo Carlo-Stella · Principal investigator
  • University Teaching Centre, Early Clinical Trials Unit
    Gdansk, 80-214, Poland
    Recruiting
    • Rafal Dziadziuszko · Principal investigator
  • Pratia MCM Krakow
    Krakow, 30-510, Poland
    Withdrawn

    Not enrolling at this site — choose another above.

  • Polish Mother's Memorial Hospital-Research Institute
    Lodz, 93-338, Poland
    Withdrawn

    Not enrolling at this site — choose another above.

  • Pratia - Poznan
    Poznan, 60-192, Poland
    Completed

    Not enrolling at this site — choose another above.

  • University Teaching Hospital in Poznan, Department of Gynecologic Oncology
    Poznan, 60-569, Poland
    Recruiting
    • Radoslaw Madry · Principal investigator
  • Maria Sklodowska-Curie - National Research Institute of Oncology
    Warsaw, 02-781, Poland
    Completed

    Not enrolling at this site — choose another above.

  • Keimyung University - Dongsan Medical Center
    Daegu, 42601, South Korea
    Withdrawn

    Not enrolling at this site — choose another above.

  • National Cancer Center
    Goyang-si, 10408, South Korea
    Completed

    Not enrolling at this site — choose another above.

  • Gachon University Gil Medical Center
    Incheon, 21565, South Korea
    Recruiting
    • Kwang-Beom Lee · Principal investigator
  • Seoul National University Hospital
    Seoul, 03080, South Korea
    Recruiting
    • Jae Weon Kim · Principal investigator
  • Severance Hospital, Yonsei University Health System
    Seoul, 03722, South Korea
    Recruiting
    • Jung-Yun Lee · Principal investigator
  • Asan Medical Center
    Seoul, 05505, South Korea
    Recruiting
    • Shin Wha Lee · Principal investigator
  • Gangnam Severance Hospital
    Seoul, 06273, South Korea
    Recruiting
    • Jae-Hoon Kim · Principal investigator
  • The Catholic University of Korea, Seoul St. Mary's Hospital
    Seoul, 06591, South Korea
    Withdrawn

    Not enrolling at this site — choose another above.

  • University Hospital Vall d'Hebron
    Barcelona, 08035, Spain
    Recruiting
    • Ana Oaknin · Principal investigator
  • Hospital Clinic of Barcelona
    Barcelona, 08036, Spain
    Recruiting
    • Begona Mellado Gonzalez · Principal investigator
  • University Hospital of Girona Dr. Josep Trueta
    Girona, 17007, Spain
    Recruiting
    • Maria Pilar Barretina Ginesta · Principal investigator
  • Catalan Institute of Oncology, Hospital Duran i Reynals
    L'Hospitalet de Llobregat, 08908, Spain
    Withdrawn

    Not enrolling at this site — choose another above.

  • University Clinic of Navarra - Madrid
    Madrid, 28027, Spain
    Recruiting
    • Antonio Gonzalez Martin · Principal investigator
  • University Hospital Ramon y Cajal
    Madrid, 28034, Spain
    Recruiting
    • Teresa Alonso Gordoa · Principal investigator
  • University Hospital Clinical San Carlos, Department of Medical Oncology
    Madrid, 28040, Spain
    Recruiting
    • Jorge Bartolome Arcilla · Principal investigator
  • University Hospital Foundation Jimenez Diaz
    Madrid, 28040, Spain
    Recruiting
    • Bernard Gaston Doger De Speville · Principal investigator
  • University Hospital 12 de Octubre
    Madrid, 28041, Spain
    Completed

    Not enrolling at this site — choose another above.

  • University Hospital Quiron Madrid
    Madrid, 28223, Spain
    Recruiting
    • Jesus Fuentes Antras · Principal investigator
  • University Hospital Puerta de Hierro Majadahonda
    Majadahonda, 28222, Spain
    Recruiting
    • Aranzazu Gonzalez-Del-Alba · Principal investigator
  • University Hospital Son Espases
    Palma, 07120, Spain
    Recruiting
    • Marina Justo de la Pena · Principal investigator
  • University Clinic of Navarra - Pamplona
    Pamplona, 31008, Spain
    Recruiting
    • Antonio Gonzalez Martin · Principal investigator
  • Parc Tauli Health Corporation
    Sabadell, 08208, Spain
    Recruiting
    • Enrique Gallardo Diaz · Principal investigator
  • University Clinical Hospital of Salamanca
    Salamanca, 37007, Spain
    Completed

    Not enrolling at this site — choose another above.

  • University Hospital Complex of Santiago (CHUS)
    Santiago de Compostela, 15706, Spain
    Recruiting
    • Maria Teresa Curiel Garcia · Principal investigator
  • University Hospital Virgen del Rocio (HUVR)
    Seville, 41013, Spain
    Recruiting
    • Alejandro Falcon Gonzalez · Principal investigator
  • Valencia Oncology Institute (IVO)
    Valencia, 46009, Spain
    Recruiting
    • Ignacio Romero Noguera · Principal investigator
  • University and Polytechnic Hospital La Fe
    Valencia, 46026, Spain
    Recruiting
    • Regina Girones Sarrio · Principal investigator
  • Royal United Hospital, Department of Oncology/Hematology
    Bath, BA1 3NG, United Kingdom
    Withdrawn

    Not enrolling at this site — choose another above.

  • Leicester Royal Infirmary
    Leicester, LE1 5WW, United Kingdom
    Recruiting
    • Harriet Walter · Principal investigator
  • Royal Marsden Hospital - London
    London, SW3 6JJ, United Kingdom
    Withdrawn

    Not enrolling at this site — choose another above.

  • Imperial College Healthcare NHS Trust
    London, SW7 2AZ, United Kingdom
    Withdrawn

    Not enrolling at this site — choose another above.

  • The Christie NHS Foundation Trust, Department of Medical Oncology
    Manchester, M20 4BX, United Kingdom
    Completed

    Not enrolling at this site — choose another above.

  • Churchill Hospital
    Oxford, OX3 7LE, United Kingdom
    Withdrawn

    Not enrolling at this site — choose another above.

  • University Hospital Southampton NHS Foundation Trust
    Southampton, SO16 6YD, United Kingdom
    Withdrawn

    Not enrolling at this site — choose another above.

  • Royal Marsden Hospital - Sutton
    Sutton, SM2 5PT, United Kingdom
    Completed

    Not enrolling at this site — choose another above.

  • Musgrove Park Hospital
    Taunton, TA1 5DA, United Kingdom
    Completed

    Not enrolling at this site — choose another above.

08

References and documents

Individual participant data

Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04104776
Responsible party
Sponsor
First posted
Sep 26, 2019
Start date
Sep 18, 2019
Primary completion
Feb 27, 2030 (estimated)
Completion
Feb 27, 2030 (estimated)
Last update
Aug 19, 2026

Study contacts

Novartis Pharmaceuticals
Contact
novartis.email@novartis.com
1-888-669-6682
Novartis Pharmaceuticals
Contact
novartis.email@novartis.com
+41613241111
Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Tulmimetostat

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