NCT06549790

Study of NMS-03597812 in Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia

A Phase Ia/Ib Study of NMS-03597812 in Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia Including Patients With TP53 Mutations

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Nerviano Medical Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of PERKA-812-003 study is to investigate the safety, pharmacokinetics and preliminary anti-tumor activity of treatment with NMS-03597812 as single agent in Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) patients who have exhausted standard treatment, including a subset of patients with TP53 mutations. It is anticipated that combination with venetoclax will be further evaluated following a future protocol amendment, once the Recommended Range Dose (RDR) as single agent has been defined.

Conditions

• Relapsed/Refractory Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	NMS-03597812	Route of Administration: Oral

Timeline

• Start date: 2024-10-16
• Primary completion: 2029-09-15
• Completion: 2030-05-15
• First posted: 2024-08-12
• Last updated: 2025-10-31

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study