drugset / Trial / NCT06549790

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

NCT06549790 ↗

Phase 1 Recruiting 124 enrolled Nerviano Medical Sciences
NaSequentialOpen-labelTreatment

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.

Timeline

Start
2024-10-16
Primary completion
2029-09-15
Completion
2030-05-15

Drugs

EvaluationDrugModalityDoseRoute
Subject NMS-03597812 Unknown — Oral