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RecruitingPriority 3 · Moderate priorityNCT04104776

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

ClinicalTrials.gov

Plain-language summary

This trial is testing tulmimetostat (an EZH2 inhibitor, also known as CPI-0209 or DZR123) for patients with various types of peripheral T-cell lymphoma (PTCL) who have been newly diagnosed and have not yet received treatment as well as those whose disease has come back or stopped responding to prior treatment. This is a Phase 1/2 trial, which means researchers are determining the best dose and getting early information about effectiveness. Patients are randomly assigned to different treatment groups. This trial is available at 22 locations in the United States. The trial is currently recruiting patients.

Who can join (key eligibility)

  • Age 18 Years or older
  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

Tulmimetostat (DRUG): Tulmimetostat dosed once per day orally in 28 day cycles | Enzalutamide (DRUG): Enzalutamide dosed once per day orally in 28 day cycles

  • Tulmimetostat, Enzalutamide

Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

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TrialCompass — Clinical Trial Summary

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

NCT04104776

Phase: Phase 1, Phase 2 | Status: Recruiting | Priority: Medium

Plain-language summary

This trial is testing tulmimetostat (an EZH2 inhibitor, also known as CPI-0209 or DZR123) for patients with various types of peripheral T-cell lymphoma (PTCL) who have been newly diagnosed and have not yet received treatment as well as those whose disease has come back or stopped responding to prior treatment. This is a Phase 1/2 trial, which means researchers are determining the best dose and getting early information about effectiveness. Patients are randomly assigned to different treatment groups. This trial is available at 22 locations in the United States. The trial is currently recruiting patients.

Who can join

  • Age 18 Years or older
  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)

What's being tested

Tulmimetostat (DRUG): Tulmimetostat dosed once per day orally in 28 day cycles | Enzalutamide (DRUG): Enzalutamide dosed once per day orally in 28 day cycles

Drugs / treatments: Tulmimetostat, Enzalutamide

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 300 patients

Primary endpoint: Tulmimetostat Monotherapy Phase 1: Frequency of Dose-limiting toxicities (DLTs); Tulmimetostat Monotherapy Phase 2: Overall response rate (ORR); Cohort M8 Part 1: Frequency of Dose-limiting toxicities (DLTs); Cohort M8 Part 2: Prostate-Specific Antigen 50 (PSA50) Response

Ages: 18 Years to —

Start date: 2019-09-18 | Est. completion: 2030-02-27

Locations

22 US sites · 81 total

Florida, Georgia, Illinois, Maryland, Massachusetts, Michigan, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia, Washington

Contact

Novartis Pharmaceuticals | novartis.email@novartis.com | 1-888-669-6682

Sponsor: Novartis Pharmaceuticals (INDUSTRY)

Tags

All T-cell lymphomas · Newly diagnosed · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT04104776

Prepared using TrialCompass (trialcompass.com) on August 2, 2026. For informational purposes only. Always discuss with your healthcare team.