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Taking people in PolandPhase 1/2

Tests tulmimetostat alone and with enzalutamide in advanced cancers

Tests tulmimetostat, alone or with enzalutamide, in adults with advanced cancers.

Key facts

Who runs it
Novartis Pharmaceuticals
Where
Gdansk, Poznan, and Warsaw, PolandSee the 3 sitesAlso in 6 other countries, 73 sites
Registry title
A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas
Status
Recruiting
Phase
Phase 1/2
People taking part
300 people, planned
Started
18 Sept 2019
Expected to end
27 Feb 2030
Type of study
Interventional, 10 groups
Treatments tested
  • Tulmimetostat
  • Enzalutamide
Record updated
19 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced solid tumors or lymphoma that has come back or not responded to standard treatment. Some groups need a specific gene change such as ARID1A.

Age
18 years or older.
Sex
All sexes can join.
Disease stage
Locally advanced or metastatic solid tumors or lymphoma, refractory to standard therapy or with no effective standard treatment. Specific groups include urothelial, ovarian clear cell, endometrial, peripheral T cell lymphoma, diffuse large B cell lymphoma, mesothelioma and metastatic castration-resistant prostate cancer.
Earlier treatment
Disease must be refractory to standard therapy or have no effective standard treatment. Some groups need earlier treatment such as platinum-based therapy, immunotherapy, AR targeted therapy or taxane chemotherapy. Prior EZH2 inhibitor treatment is not allowed.
Biomarker or test result
Some groups need an ARID1A mutation (urothelial and other solid tumors, ovarian clear cell, endometrial). The mesothelioma group needs documented BAP1 loss. One endometrial group is ARID1A wild type.

Main reasons for not taking part

  • Prior solid organ or allogeneic hematopoietic cell transplant
  • Active or untreated symptomatic CNS metastases
  • Active HIV or hepatitis B/C infection
  • Pregnancy or breastfeeding
  • Prior EZH2 inhibitor treatment

The registry criteria, word for word

Show all 35 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Prior solid organ or allogeneic hematopoietic cell transplant
  • 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:
  • M8 (Combination): PSA-only disease, prior investigational androgen receptor pathway inhibitors, significant seizure risk, extensive prior bone marrow irradiation, active inflammatory gastrointestinal disease
  • Medical Conditions:
  • Active interstitial lung disease or pneumonitis
  • Uncontrolled infections or significant gastrointestinal disorders affecting absorption
  • Active HIV or hepatitis B/C infection
  • M6 (mCRPC): Bone-only disease, unstable bone lesions, PSA-lowering herbal products, recent prohibited prostate cancer therapies
  • Clinically significant cardiovascular disease, including uncontrolled arrhythmias or prolonged QTc
  • All Patients:
  • Active or untreated symptomatic CNS metastases (with limited exceptions)

Where in Poland

Also in 6 other countries, 73 sites

  • Uniwersyteckie Centrum KliniczneGdansk, PolandTaking people
  • Pratia S.A.Poznan, PolandTaking people
  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyWarsaw, PolandTaking people

About the trial

What the trial wants to find out

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.

The 10 groups in the trial

  • Phase 1Treatment being tested

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

    Treatment: Tulmimetostat

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

    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.

    Treatment: Tulmimetostat

  • Phase 2 - Cohort M2 (Ovarian clear cell carcinoma with ARID1A mutation)Treatment being tested

    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.

    Treatment: Tulmimetostat

  • Phase 2 - Cohort M3 (Endometrial carcinoma with ARID1A mutation)Treatment being tested

    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.

    Treatment: Tulmimetostat

  • Phase 2 - Cohort M4 (Relapsed/refractory lymphoma (PTCL or DLBCL))Treatment being tested

    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.

    Treatment: Tulmimetostat

  • Phase 2 - Cohort M5 (Malignant mesothelioma with BAP1 loss)Treatment being tested

    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.

    Treatment: Tulmimetostat

  • Phase 2 - Cohort M6 (Metastatic castration-resistant prostate cancer (mCRPC))Treatment being tested

    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.

    Treatment: Tulmimetostat

  • Phase 2 - Cohort M7 (Food effect in ARID1A wildtype endometrial carcinoma)Treatment being tested

    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.

    Treatment: Tulmimetostat

  • Cohort M8 - Part 1 (Tulmimetostat + enzalutamide in mCRPC)Treatment being tested

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

    Treatment: Tulmimetostat

  • Cohort M8 - Part 2 (Tulmimetostat + enzalutamide in mCRPC)Treatment being tested

    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.

    Treatment: Tulmimetostat and Enzalutamide

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 1/2 Study of DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas
Plain-language title
Tests tulmimetostat alone and with enzalutamide in advanced cancersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
19 August 2026