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A Phase 1, Open-label, Dose Escalation and Dose Expansion, Multicenter Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ZE46-0134 in Adults With FLT3 Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML)

Trial Profile

A Phase 1, Open-label, Dose Escalation and Dose Expansion, Multicenter Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ZE46-0134 in Adults With FLT3 Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML)

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 06 Aug 2025

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At a glance

  • Drugs Lomonitinib (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions
  • Sponsors Eilean Therapeutics

Most Recent Events

  • 23 Jul 2025 Treatment has been amended, number of arm has been changed from 8 to 11.
  • 23 Jul 2025 Planned End Date changed from 1 Jan 2026 to 1 Dec 2027.
  • 23 Jul 2025 Planned primary completion date changed from 1 Sep 2025 to 1 Jan 2026.

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