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

NCT03850574 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-08-26

No results posted yet for this study

Summary

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

Interventions

DRUG

Tuspetinib

Daily (QD), continuous dosing

DRUG

Venetoclax Oral Tablet

Venetoclax will be given to study participants in the Part C tuspetinib plus venetoclax combination treatment group either in 50 mg or 100 mg tablets

DRUG

Azacitidine for Intravenous Infusion

Azacitidine will be given to study participants in Part D as intravenous infusion at a dose of 75 mg/m\^2

Sponsors & Collaborators

  • Aptose Biosciences Inc.

    lead INDUSTRY

Principal Investigators

  • Naval Daver, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-11
Primary Completion
2026-11-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Germany
  • New Zealand
  • South Korea
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03850574 on ClinicalTrials.gov