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Study of Tulmimetostat (DZR123) for Advanced Solid Tumors and Lymphomas

This study is testing a new drug called Tulmimetostat (DZR123), alone or with Enzalutamide, for people with advanced solid tumors and lymphomas, including specific types like diffuse large B-cell lymphoma and prostate cancer. Researchers want to see how safe it is, how well your body handles it, and if it helps shrink tumors. They will also look for specific markers in your body, like ARID1A and BRCA1, which might help predict how well the treatment works. The study aims to find the best dose and see how many people respond to the treatment. You might be able to join if you are an adult with advanced cancer, have a good performance status (meaning you can do most daily activities), and meet other health requirements. The study is currently unclear on its recruitment status and plans to enroll about 300 participants.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It involves different phases to find the right dose and then test the drug in specific cancer types, with about 300 participants planned.
What's involved
You would take Tulmimetostat (and potentially Enzalutamide) by mouth once a day in 28-day cycles. You will also need to provide tumor tissue and blood samples for biomarker analyses.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you will be followed to monitor survival and for any new cancers, with assessments approximately every 3 months for the first 3 years, and every 6 months after that.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04104776

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~300 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:TulmimetostatEnzalutamide

At a glance

Recruiting sites
43 of 80 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tulmimetostat Monotherapy Phase 1: Frequency of Dose-limiting toxicities (DLTs)
Measured over DLTs assessed during Cycle 1 (cycle = 28 days)
+3 more outcomes measured

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

Explore related trials

Diffuse Large B-Cell LymphomaEndometrial CarcinomaHematologic NeoplasmMesothelial NeoplasmOvarian Clear Cell AdenocarcinomaProstate CarcinomaSolid NeoplasmT-Cell Non-Hodgkin LymphomaUrothelial CarcinomaAT-Rich Interactive Domain-Containing Protein 1ABAP1 Gene

Where it's being run

80 sites across 19 states
Spain19
United Kingdom9
France8
Italy8
South Korea8
New York6
Poland6
Illinois2

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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
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
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
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
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

What this trial measures

  • Tulmimetostat Monotherapy Phase 1: Frequency of Dose-limiting toxicities (DLTs)DLTs assessed during Cycle 1 (cycle = 28 days)

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

  • Tulmimetostat Monotherapy Phase 2: Overall response rate (ORR)Up to 30 months

    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

  • Cohort M8 Part 1: Frequency of Dose-limiting toxicities (DLTs)DLTs assessed during Cycle 1 (cycle = 28 days)

    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.

  • Cohort M8 Part 2: Prostate-Specific Antigen 50 (PSA50) ResponseUp to 30 months

    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