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

Active:	Yes
Cancer Type:	Leukemia	NCT ID:	NCT03850574
Trial Phases:	Phase I Phase II	Protocol IDs:	HM-FLTI-101 (primary) NCI-2019-06837
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Aptose Biosciences
NCI Full Details:	http://clinicaltrials.gov/show/NCT03850574

Summary

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

Objectives

This is a Phase 1/2, open-label, multi-center study to assess the efficacy, safety,
tolerability, pharmacokinetics, including recommended phase 2 dose (RP2D) of tuspetinib
(HM43239) monotherapy in subjects with relapsed or treatment-refractory acute myeloid
leukemia (AML). This study will also evaluate the safety, tolerability, and PK parameters
of tuspetinib (HM43239) in combination with venetoclax when administered in patients with
R/R AML

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