A FIH study of KO-539 in patients with relapsed or refractory AML

• Research type

  Research Study

• Full title

  A Phase 1/2A First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients with Relapsed or Refractory Acute Myeloid Leukemia

• IRAS ID

  281052

• Contact name

  Matt Kelly

• Contact email

  mkelly@kuraoncology.com

• Sponsor organisation

  Kura Oncology, Inc.

• Eudract number

  2019-001545-41

• Clinicaltrials.gov Identifier

  NCT04067336

• Clinicaltrials.gov Identifier

  142028, IND

• Duration of Study in the UK

  3 years, months, days

• Research summary

  In this study an investigational drug KO-539 will be used for the first time in patients with relapsed or refractory AML (Acute Myeloid Leukaemia). Potential study participants must be 18 years and older, read study information, understand and be eligible to give consent to take part in this study.
  It is estimated that a total of approximately 90 patients will be enrolled in the Phase 1 portion of the study.
  The Phase 1 of the study will be conducted in 2 parts. The dose-escalation part (Part 1a) will determine the maximal tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D). The dose-validation/ cohort expansion portion of the study (Part 1b) will expand at dose levels deemed safe in Part 1a to establish the safety, tolerability and an optimal biologically active dose of KO-539 for Phase 2 of the study. Part 1b will be conducted in 2 groups with different genetic subsets. Only Part 1b of this study is conducted in the UK.

  KO-539 will be administered as a once daily oral dose in 28 continuous day cycles.
  Mandatory blood and bone marrow sampling for biobanking, biomarker testing and central analysis will also be required from all patients in order to guide the translational work required for a subsequent Phase 2 expansion.

  Study participants will undergo physical examinations, Echocardiograms, blood sampling for safety, pharmacokinetics, pharmacodynamics and biomarkers.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  21/LO/0577

• Date of REC Opinion

  4 Oct 2021

• REC opinion

  Further Information Favourable Opinion