RecruitingPhase 1 / Phase 2

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

A Phase 1/2 Study of DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests tulmimetostat (DZR123) alone or with enzalutamide in adults with advanced solid tumors or lymphoma, a cancer of the immune system. Researchers will study its safety, how the body handles it, and whether it helps fight cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and expected to live at least 12 weeks.
  • Be fully active or able to do light work, even if hard physical activity is limited.
  • Have recovered from most side effects of past treatment and have blood, kidney, and liver test results that meet study rules.
  • Agree to give tumor tissue and blood samples and follow the study’s birth control rules.
  • Sign a consent form before any study procedures.
  • For Phase 1: Have a confirmed solid tumor or lymphoma that has spread nearby or farther away. Standard treatment must have stopped working, or no effective standard treatment is available.
  • For Phase 2: Have one of the listed types of bladder or urinary tract, ovarian, uterine, prostate, or other solid cancers; lymphoma; or mesothelioma, a cancer of the lining around the lungs or belly. Each group has its own rules for gene changes, past treatments, and measuring the cancer.
  • For prostate cancer: Meet the group’s treatment rules. Phase 1 requires testosterone to stay very low; Phase 2 requires cancer that has spread and grows despite very low testosterone.

Who can't join

  • A past organ transplant or a blood-forming cell transplant from a donor.
  • Active or untreated cancer spread to the brain or spinal cord that causes symptoms, with limited exceptions.
  • Serious heart disease, including uncontrolled heart rhythm problems; active lung inflammation or scarring; or major gut problems that affect how medicines are absorbed.
  • Uncontrolled infections, active HIV or hepatitis B or C, or another cancer needing treatment, with some exceptions.
  • Being pregnant or breastfeeding, or being unable to follow study rules.
  • Past treatment with an EZH2-blocking drug, cancer treatment or radiation too recently, or certain medicines that strongly change how the body processes the study drug.
  • For the prostate cancer M6 group: Cancer only in the bones, unstable areas of bone damage, herbs that lower PSA (a prostate cancer blood marker), or certain recent prostate cancer treatments.
  • For the combination M8 group: Cancer shown only by rising PSA, past use of certain experimental hormone-blocking drugs, high seizure risk, extensive radiation to bone marrow, or active gut inflammation.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (22)

FL

GA

  • Winship Cancer Institute of Emory University · Atlanta, GA 30322-1013Beryl Manning-Geist, MD · Principal investigatorMore trials in Atlanta

IL

MA

MD

MI

NJ

NY

OH

PA

  • Abramson Cancer Center of the University of Pennsylvania · Philadelphia, PA 19104Lainie Martin, MD · Principal investigatorMore trials in Philadelphia

TX

VA

WA

  • Swedish Cancer Institute · Seattle, WA 98104Charles Drescher, MD · Principal investigatorMore trials in Seattle
  • Fred Hutchinson Cancer Center · Seattle, WA 98109-1023Kalyan Banda, MD · Principal investigatorMore trials in Seattle