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APTO-253 for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Research Sponsored by Aptose Biosciences Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 months
Awards & highlights

Summary

This trial is testing a new drug, APTO-253, to see if it's safe and effective for patients with acute myelogenous leukemia or myelodysplastic syndrome.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Myelodysplasia
  • Acute Myelogenous Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Establish recommended dose for future development of APTO-253
Incidence of treatment-emergent adverse events of APTO-253
Maximum tolerated dose and dose limiting toxicities
Secondary study objectives
Assess for any evidence of antitumor activity of APTO-253 by hematologic and bone marrow evaluations in acute leukemia and MDS.
Determine the ability of APTO-253 to alter the expression of pharmacodynamic biomarkers of drug effect.
Pharmacokinetic variables including Area Under the Curve (AUC)
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose Escalation and ExpansionExperimental Treatment1 Intervention
APTO-253 will be given in ascending doses in patients with relapsed or refractory AML or high risk MDS (escalation cohort), until the maximum tolerated dose or recommended dose is reached. Followed by up to 30 patients enrolled in the expansion cohort at the recommended dose.

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Who is running the clinical trial?

Aptose Biosciences Inc.Lead Sponsor
7 Previous Clinical Trials
1,006 Total Patients Enrolled
Rafael Bejar, MD., PhD.Study DirectorAptose Biosciences Inc.
~2 spots leftby Sep 2025
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