RecruitingLeukemia, Myeloid, AcuteRefractory AMLRelapsed Adult AML

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

Eligible age

18+ yrs

Accepts

All genders

Locations

9 states

Healthy volunteers

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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.

Sponsor: Aptose Biosciences Inc.

You may qualify if…

✓ Study participant is defined as having morphologically documented primary or secondary AML, MDS-IB2 (≥ 10% bone marrow blasts), or CMML by the World Health Organization (WHO) criteria (2016), and fulfills one of the following:
✓ 1. Refractory to at least 1 cycle of prior therapy
✓ 2. Relapsed after achieving remission with a prior therapy
✓ Study participant has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
✓ Study participant's interval from prior treatment to time of study drug administration is at least 2 weeks for cytotoxic agents (except hydroxyurea given for controlling blast cells), at 4 weeks for biologic or cellular immunotherapies, or least 5 half-lives for prior experimental agents or noncytotoxic agents, including immunosuppressive therapy post hematopoietic stem cell transplantation (HSCT). Upon discussion with the Medical Monitor, a shorter than stated washout period may be considered provided that the study participant has recovered from any clinically relevant safety issue and recovered to Grade ≤ 1 toxicity from prior therapies.
✓ Study participant must meet the following criteria as indicated on the clinical laboratory tests.
✓ 1. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3× institutional upper limit normal (ULN)
✓ 2. Total serum bilirubin ≤ 1.5× institutional ULN

You may not qualify if…

✕ Study participants must not enter the study if any of the following exclusion criteria are met:
✕ Study participant was diagnosed with acute promyelocytic leukemia (APL).
✕ Study participant has known BCR-ABL-positive leukemia.
✕ Study participant has an active malignancy other than AML, MDS-IB2, or CMML.
✕ Study participant has persistent non-hematological toxicities of ≥ Grade 2 (CTCAE v4.03), with symptoms and objective findings, from prior AML, MDS-IB2, or CMML treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, or surgery)
✕ Study participant has had hematopoietic stem cell transplant (HSCT) and meets any of the following criteria:
✕ 1. Has undergone HSCT within the 2-month period prior to the first study dose
✕ 2. Has clinically significant graft-versus-host-disease (GVHD) requiring treatment