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Phase 1Recruiting

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

Sponsored by Novartis Pharmaceuticals

About this study

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.

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. …

Where this study is enrolling (2)

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia

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  • University of Chicago Medical Center

    Chicago, Illinois

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Who can participate

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

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

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Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.