Tests tulmimetostat alone and with enzalutamide in advanced cancers
Tests tulmimetostat, alone or with enzalutamide, in adults with advanced cancers.
Plain-language title generated from the registry record
Registry title: A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas
Key facts
- Where
- Barcelona, Girona, Madrid, Majadahonda, Palma, Pamplona, Pozuelo de Alarcón, Sabadell, Salamanca, Santiago de Compostela, Sevilla, and Valencia, SpainSee the 18 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
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
Read by machine on 12 November 2026.
Where in Spain
- Hospital Clinic de BarcelonaBarcelona, SpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Institut Català d'OncologiaGirona, SpainTaking people
- Clinica Universidad de NavarraMadrid, SpainTaking people
- Hospital Clínico San CarlosMadrid, SpainTaking people
- Hospital Universitario 12 de OctubreMadrid, SpainTaking people
- Hospital Universitario Fundación Jiménez DíazMadrid, SpainTaking people
- Hospital Universitario Ramón y CajalMadrid, SpainTaking people
- Hospital Universitario Puerta de Hierro de MajadahondaMajadahonda, SpainTaking people
- University Hospital Son EspasesPalma, SpainTaking people
- Clínica Universidad de navarraPamplona, SpainTaking people
- Hospital Universitario Quironsalud MadridPozuelo de Alarcón, SpainTaking people
- Parc Tauli Hospital UniversitariSabadell, SpainTaking people
- Hospital Universitario De SalamancaSalamanca, SpainTaking people
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpainTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainTaking people
- Fundación Instituto Valenciano de OncologíaValencia, SpainTaking people
- Hospital Universitario Y Politecnico La FeValencia, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT04104776EU 2023-508002-20-00
- Record updated
- 19 August 2026
- Original 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.Read full original descriptionShow less
A Phase 1/2 Study of DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas
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.
Inclusion: 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.
Exclusion: 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).