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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT05944562
Phase
PHASE1
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tulmimetostat — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 9, 2024
Status verified
May 2026
Primary completion
Feb 28, 2027
Completion
Jan 31, 2029

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose De-Escalation Cohort: Tulmimetostat (DZR123)
    Daily DZR123 by mouth for days 1-28 of each 28-day cycle. Dose will depend on dose level assignment of 300 mg daily, 250 mg daily, or 200 mg daily.
  • Experimental: Dose Expansion Cohort: Tulmimetostat (DZR123) - 300 mg
    Daily DZR123by mouth for days 1-28 of each 28-day cycle. Dose will be the maximum-tolerated dose found during the dose de-escalation cohort which was 300 mg.
  • Experimental: Dose Expansion Cohort: Tulmimetostat (DZR123) - 200 mg
    Daily DZR123 by mouth for days 1-28 of each 28-day cycle. Dose will be 200 mg as the maximum tolerated dose of 300 mg found during the initial dose expansion cohort caused numerous dose reductions.

Primary Outcome Measure

Frequency and grades of treatment-emergent adverse events (TEAE) [ Time Frame: From start of treatment through 30 days after completion of treatment (estimated to be 13 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

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By research site
Washington University School of Medicine· St Louis, MO

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