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RecruitingLast updated:29 August 2023

APTIVATE: This study is evaluating how safe, tolerable and effective targeted therapy (called tuspetinib) is in people with relapsed or refractory acute myeloid leukaemiaA 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 summary

Summary

This study will run in three stages: dose escalation, dose exploration and dose expansion. In Part A (dose escalation), participants will receive tuspetinib daily. Dose escalation cohort is planned for up to 6 cohort levels. In Part B (dose exploration), participants will receive tuspetinib daily. Dose exploration is planned for up to 4 dose levels. Part C (dose expansion) consists of two treatment arms and participants and participants will be randomly assigned to either arm. Participants in Arm 1 will receive tuspetinib alone, daily. Participants in Arm 2 will receive tuspetinib plus venetoclax (another targeted therapy).

Treatment Type

Radiotherapy

Age

People18+

Phase

I/II

Trial Acronym

APTIVATE

More information

Trial Identifiers

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Commercial Sponsor

Aptose Biosciences Inc.

Scientific 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)

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Exclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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