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

Description

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.

Conditions

Leukemia, Myeloid, Acute, Refractory AML, Relapsed Adult AML, Myelodysplastic Syndrome With Excess Blasts-2, Chronic Myelomonocytic Leukemia

Study Overview

Study Details

Study overview

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.

A Phase 1/2 Open Label, Multicenter, Dose Escalation and Expansion Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM43239 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

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
Intervention / Treatment

-

Contacts and Locations

Birmingham

The Kirklin Clinic of UAB Hospital, Birmingham, Alabama, United States, 35233

Duarte

City of Hope Comprehensive Cancer Center, Duarte, California, United States, 91010

Irvine

University of California Irvine, Irvine, California, United States, 92697

La Jolla

UCSD Moores Cancer Center, La Jolla, California, United States, 92093

Los Angeles

USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90033

Palo Alto

Stanford Cancer Center, Palo Alto, California, United States, 94304

Sacramento

University of California, Davis, Sacramento, California, United States, 95817

New Haven

Yale University, New Haven, Connecticut, United States, 06520

Miami

University of Miami - Miller School of Medicine, Miami, Florida, United States, 33136

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Aptose Biosciences Inc.,

    Naval Daver, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

    Study Record Dates

    2026-12