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A Phase IIa, Open-label, Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of BP1001 (a Liposomal Grb2 Antisense Oligonucleotide) in Combination With Venetoclax Plus Decitabine in Patients With AML Who Are Ineligible for Intensive Induction Therapy

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Trial Profile

A Phase IIa, Open-label, Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of BP1001 (a Liposomal Grb2 Antisense Oligonucleotide) in Combination With Venetoclax Plus Decitabine in Patients With AML Who Are Ineligible for Intensive Induction Therapy

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 10 Mar 2025

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At a glance

  • Drugs Decitabine (Primary) ; Prexigebersen (Primary) ; Venetoclax (Primary)
  • Indications Acute myeloid leukaemia; Chronic myelomonocytic leukaemia; Myelodysplastic syndromes
  • Focus Registrational; Therapeutic Use
  • Sponsors Bio-Path Holdings

Most Recent Events

  • 07 Mar 2025 Planned End Date changed from 1 Dec 2024 to 1 Dec 2028.
  • 07 Mar 2025 Planned primary completion date changed from 1 Dec 2024 to 1 Dec 2027.
  • 10 Jan 2025 According to a Bio-Path Holdings media release, Bio-Path expects to utilize an advisory panel of AML experts to assist in the design of the final clinical development plans through potential FDA approval. Completion of Cohort 2 and an interim analysis for Cohort 3 expected in 2025.

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