A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)

This study evaluates the safety and tolerability of escalating doses of BP1002 (Liposomal Bcl-2 Antisense Oligodeoxynucleotide) in patients with refractory/relapsed AML. The study is designed to assess the safety profile, identify DLTs, biologically effective doses, PK, PD and potential anti-leukemic effects of BP1002 as single agent (dose escalation phase) followed by assessing BP1002 in combination with decitabine (dose expansion phase).

Trial Details

NCT ID
NCT05190471
Phase
PHASE1
Sponsor
Bio-Path Holdings, Inc.
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • BP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide
  • Decitabine (in combination with BP1002)
Locations (sample)
  • La Jolla, California, United States|32.84727,-117.2742
  • Los Angeles, California, United States|34.05223,-118.24368
  • New York, New York, United States|40.71427,-74.00597
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Adults ≥18 years of age, with histologic evidence of refractory/relapsed AML who have failed treatment with available therapies known to be active …
  • Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1 or 2
  • For the dose expansion phase, participants with documented diagnosis of AML who are eligible for decitabine therapy
  • Participants must have adequate hepatic and renal functions as defined by:

For full eligibility, visit ClinicalTrials.gov.

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