Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05944562 | Tulmimetostat (DZR123) in Patients With Mycosis Fungoides and Sézary Syndrome | PHASE1 | ACTIVE NOT_RECRUITING | 24 | — | — | Jan 9, 2024 | Jan 31, 2029 | May 20, 2026 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Dose De-Escalation Cohort: Tulmimetostat (DZR123) | EXPERIMENTAL | 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. |
| Dose Expansion Cohort: Tulmimetostat (DZR123) - 300 mg | EXPERIMENTAL | 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. |
| Dose Expansion Cohort: Tulmimetostat (DZR123) - 200 mg | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: * Histologically or cytologically confirmed mycosis fungoides or Sézary syndrome, stages IB to IVB with measurable disease and/or detectable blood involvement based on the Global Response Criteria for CTCL (Olsen et al., 2022). * Received at least one prior line of systemic ther...