NCT04638309

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

Phase 1 Study to Evaluate Safety and Efficacy of APR-548 in Combination With Azacitidine for the Treatment of TP53-Mutant Myelodysplastic Syndromes

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Aprea Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 1 study evaluating the safety and efficacy of APR-548 in combination with Azacitidine for the treatment of TP53-Mutant Myelodysplastic Syndromes.

Detailed description

Open-label first-in-human (FIH) phase 1 clinical trial assessing the safety, pharmacokinetics (PK), and clinical activity of orally (p.o.) administered APR-548 alone and in combination with azacitidine for the treatment of TP53-mutant myelodysplastic syndromes (MDS).

Conditions

• MDS
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	APR-548 + Azacitidine	APR-548 monotherapy period followed by APR-548 in combination with Azacitidine

Timeline

• Start date: 2021-09-20
• Primary completion: 2022-04-25
• Completion: 2022-04-25
• First posted: 2020-11-20
• Last updated: 2025-03-10
• Results posted: 2025-03-07

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study