Clinical Trial

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

Recruiting Phase 1
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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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2024-08-08; most recent amendment 2025-10-30.
Status change: Not Yet Recruiting → Recruiting 2024-08-27
Trial Details
NCT Number NCT06549790
Lead Sponsor Nerviano Medical Sciences
Conditions Relapsed/Refractory Acute Myeloid Leukemia
Enrollment 124 participants
Start Date 2024-10-16
Primary Completion 2029-09-15 (estimated)
Study Completion 2030-05-15 (estimated)
Updated on ClinicalTrials.gov 2025-10-31