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

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.

Trial Details

NCT ID
NCT03850574
Phase
PHASE1 / PHASE2
Sponsor
Aptose Biosciences Inc.
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Tuspetinib
  • Venetoclax Oral Tablet
  • Azacitidine for Intravenous Infusion
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Duarte, California, United States|34.13945,-117.97729
  • Irvine, California, United States|33.66946,-117.82311
  • La Jolla, California, United States|32.84727,-117.2742
  • Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

  • Study participant is defined as having morphologically documented primary or secondary AML, MDS-IB2 (≥ 10% bone marrow blasts), or CMML by the Worl…
  • Refractory to at least 1 cycle of prior therapy
  • Relapsed after achieving remission with a prior therapy
  • Study participant has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

For full eligibility, visit ClinicalTrials.gov.

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