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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)

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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)

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 13 Jun 2024

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At a glance

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

    • Most Recent Events

    • 10 Jun 2024 Status changed from not yet recruiting to recruiting, according to an Eilean Therapeutics media release.
    • 10 Jun 2024 According to an Eilean Therapeutics media release, while the Phase 1 study has already initiated in Australia, clearance from the FDA will allow the trial to be initiated in the US.
    • 10 Jun 2024 According to an Eilean Therapeutics media release, company announced that the U.S. Food and Drug Administration (FDA) has cleared the IND for lomonitinib (ZE46-0134), allowing the company to proceed with a Phase 1 clinical trial in FLT3 mutated relapsed/refractory (R/R) AML.

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