A trial to test the safety of HM43239 for the treatment of AML
Research type
Research Study
Full title
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)
IRAS ID
1007528
Contact name
Ben McCormick
Contact email
Sponsor organisation
Aptose Biosciences, Inc.
Eudract number
2023-503244-14
Clinicaltrials.gov Identifier
Research summary
This study design (originally approved in the USA and South Korea) is a first-in-human study in the UK, and it includes Part A, Part B, and Part C. Tuspetinib effectively blocks the activity of several enzymes important to the growth and survival of acute AML. These enzymes include mutated and unmutated forms of the FLT3 kinase (enzyme), the JAK1 and JAK2 kinases, and the SYK kinase, among others. Safety and tolerability are the primary objectives of the study. For each dose level and group of patients, the sponsor meets with the investigative sites (study doctors and staff) to review the available data and to assess how the next dose level should be adjusted. Patients enrolled to the study receive oral doses of tuspetinib tablets once daily in 28 day cycles without interruption. Because of the predicted effectiveness of tuspetinib against the AML disease of patients with a FLT3 mutation, the study requires a minimum number of enrolled patients who have this mutation.
REC name
London - London Bridge Research Ethics Committee
REC reference
23/LO/0390
Date of REC Opinion
20 Jun 2023
REC opinion
Further Information Favourable Opinion