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Reactivator of Tumor Suppressor Protein p53

APR-548 in Combination With Azacitidine for the Treatment of TP53 Myelodysplastic Syndromes (MDS)

Phase 1
Waitlist Available
Research Sponsored by Aprea Therapeutics
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 through study completion, approximately 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new oral drug, APR-548, combined with Azacitidine, for patients with a hard-to-treat blood disorder due to a specific genetic mutation. The combination aims to better target and kill the cancerous cells. Azacitidine is used for treating certain blood disorders, especially in patients not eligible for intensive treatments.

Eligible Conditions
  • Myelodysplastic syndrome
  • Myelodysplastic Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To investigate the safety and tolerability of APR-548 as monotherapy and in combination with azacitidine.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
Dose level 3
Group II: Cohort 2Experimental Treatment1 Intervention
Dose level 2
Group III: Cohort 1Experimental Treatment1 Intervention
Dose level 1

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Who is running the clinical trial?

Aprea TherapeuticsLead Sponsor
13 Previous Clinical Trials
917 Total Patients Enrolled
Joachim Gullbo, MDStudy DirectorTheradex Oncology
2 Previous Clinical Trials
38 Total Patients Enrolled
~1 spots leftby Dec 2025
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