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

Recruiting Phase 1 Interventional Study
Acute Myeloid Leukemia Myelodysplastic Syndrome
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Edgewood Oncology Inc. · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion 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 respect to MDS, that is high ri…
Contacts

Zung Thai, MD

415-225-9338

zung@edgewoodonc.com

CONTACT

Edgar Bautista

edgar@edgewoodonc.com

CONTACT