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Study identifier: NCT03850574 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Condition: Leukemia, Myeloid, Acute · Refractory AML · Relapsed Adult AML  ·  Sponsor: Aptose Biosciences Inc.

PhasePhase 1/Phase 2
Planned participants240
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The main purpose of this study is to identify a safe and potentially effective dose of tuspetinib to be used in future studies in study participants diagnosed with acute myeloid leukemia (AML), myelodysplastic syndromes with increased blasts grade 2 (MDS-IB2), or chronic myelomonocytic leukemia (CMML) that is relapsed or refractory after at least one line of prior therapy, or in study participants with newly diagnosed AML. Tuspetinib will be administered as a single agent or in combination with other drugs (venetoclax or venetoclax plus azacitidine), as specified for each part of the study.

This description comes directly from the study's public registry record.

Talk to the study team

Rafael Bejar, MD, PhD  ·  858-401-6852  ·  rbejar@aptose.com

Always discuss trial participation with your own doctor first.

Locations (34)

The Kirklin Clinic of UAB HospitalBirmingham, Alabama, United StatesRecruiting
City of Hope Comprehensive Cancer CenterDuarte, California, United StatesActive Not Recruiting
University of California IrvineIrvine, California, United StatesRecruiting
UCSD Moores Cancer CenterLa Jolla, California, United StatesActive Not Recruiting
USC/Norris Comprehensive Cancer CenterLos Angeles, California, United StatesRecruiting
Stanford Cancer CenterPalo Alto, California, United StatesRecruiting
University of California, DavisSacramento, California, United StatesRecruiting
Yale UniversityNew Haven, Connecticut, United StatesRecruiting
University of Miami - Miller School of MedicineMiami, Florida, United StatesRecruiting
Emory UniversityAtlanta, Georgia, United StatesActive Not Recruiting
Massachusetts General HospitalBoston, Massachusetts, United StatesActive Not Recruiting
Duke University Medical CenterDurham, North Carolina, United StatesRecruiting

+ 22 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT03850574