Clinical Trial

Dose Escalation and Expansion Study to Evaluate the Safety, PK, PD and Efficacy of ZE46-0134 in Adults With FLT3 Mutated or Spliceosome Mutated Relapsed or Refractory Acute Myeloid Leukemia

Recruiting Phase 1
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Record status
This record was last updated December 31, 2025 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of ZE46-0134 in patients with FLT3 and spliceosome mutated Relapsed or Refractory Acute Myeloid Leukemia
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-04-10; most recent amendment 2025-12-24.
Status change: Not Yet Recruiting → Recruiting 2025-07-18
Trial Details
NCT Number NCT06366789
Lead Sponsor Lomond Therapeutics Holdings, Inc.
Conditions AML With Gene Mutations
Enrollment 150 participants
Start Date 2024-05-29
Primary Completion 2026-01 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-31