NCT05944562

Tulmimetostat (DZR123) in Patients With Mycosis Fungoides and Sézary Syndrome

Phase I Study With an Expansion Cohort of Tulmimetostat (DZR123) in Patients With Mycosis Fungoides and Sézary Syndrome

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The hypotheses of this study are that single agent DZR123 will be safe and well tolerated in patients with advanced (stage IB-IVB) mycosis fungoides (MF)/Sézary syndrome (SS) who have had at least one prior systemic therapy, and that in these patients, DZR123 will demonstrate efficacy and be worth of further study.

Conditions

• Mycosis Fungoides
• Sezary Syndrome
• Mycosis Fungoides/Sezary Syndrome

Interventions

Type	Name	Description
DRUG	Tulmimetostat	Patients should take DZR123 at approximately the same time every morning in a fasted state (no food for 2 hours prior and 1 hour following DZR123 dosing). Each dose of DZR123 should be taken with a glass of water and consumed over as short a time as possible.

Timeline

• Start date: 2024-01-09
• Primary completion: 2027-02-28
• Completion: 2029-01-31
• First posted: 2023-07-13
• Last updated: 2026-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study