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Phase I Multicenter, Open-Label, First-in-Human Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double Combination With Azacitidine and in Triple Combination With Azacitidine and Venetoclax in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

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Trial Profile

Phase I Multicenter, Open-Label, First-in-Human Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double Combination With Azacitidine and in Triple Combination With Azacitidine and Venetoclax in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 13 Jun 2025

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At a glance

  • Drugs Azacitidine (Primary) ; BMS 986497 (Primary) ; Venetoclax (Primary)
  • Indications Acute myeloid leukaemia; Myelodysplastic syndromes
  • Focus Adverse reactions; First in man
  • Sponsors Bristol-Myers Squibb

Most Recent Events

  • 06 Jun 2025 The protocol has been amended to addition in safety endpoint and treatment arms.
  • 06 Jun 2025 Planned number of patients changed from 35 to 105.
  • 27 Jun 2024 Status changed from not yet recruiting to recruiting.

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