A Study of BTX-A51 in People With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

This is an open-label, dose escalation study to evaluate the safety, toxicity, and pharmacokinetics (PK) as well as preliminary efficacy of BTX-A51 capsules in participants with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). The study will be done in three parts. Part 1a (Monotherapy Dose Escalation) of this study is designed to determine the dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of orally administered BTX-A51 in up to 35 participants who are evaluable for toxicity. Once the MTD is determined, it is planned that an a

Trial Details

NCT ID
NCT04243785
Phase
PHASE1
Sponsor
Edgewood Oncology Inc.
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • BTX-A51
  • Azacitidine
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • New York, New York, United States|40.71427,-74.00597
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Demonstration of understanding and voluntarily signing of an informed consent form
  • Age ≥ 18 years
  • Diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) according to the World Health Organization classification and, with res…
  • Eastern Cooperative Oncology Group performance status ≤ 2 and life expectancy of ≥ 6 weeks

For full eligibility, visit ClinicalTrials.gov.

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