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A First-in-human Dose Escalation and Expansion Trial With the Antibody-drug Conjugate BYON4413 to Evaluate Safety, Pharmacokinetics, and Preliminary Efficacy in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms.

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Trial Profile

A First-in-human Dose Escalation and Expansion Trial With the Antibody-drug Conjugate BYON4413 to Evaluate Safety, Pharmacokinetics, and Preliminary Efficacy in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms.

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 06 Apr 2026

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At a glance

  • Drugs BYON 4413 (Primary)
  • Indications Acute myeloid leukaemia; Myelodysplastic syndromes
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Byondis

Most Recent Events

  • 20 Jan 2026 Actual Primary Completion Date is 30 Sep 2025.
  • 20 Jan 2026 Planned End Date changed from 1 Mar 2027 to 1 Feb 2026.
  • 20 Jan 2026 Status changed from recruiting to active, no longer recruiting.

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