RecruitingPhase 1NCT06549790

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


Sponsor

Nerviano Medical Sciences

Enrollment

124 participants

Start Date

Oct 16, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase clinical trial is testing a new drug called NMS-03597812 in adults with relapsed or refractory acute myeloid leukemia (AML) — a fast-growing blood cancer that has come back or stopped responding to treatment. The study starts with finding the right safe dose (Phase Ia) and then tests it in specific patient groups, including those with a TP53 mutation. **You may be eligible if...** - You are an adult with AML that has come back or is not responding to standard treatment - You have already tried standard therapies such as intensive chemotherapy, hypomethylating agents with venetoclax, FLT3 inhibitors, or IDH inhibitors — and they did not work - Your organ function (heart, liver, kidneys) meets the required levels - You are in reasonable physical condition **You may NOT be eligible if...** - You have not yet tried available standard treatments - You have active brain involvement from leukemia - You have active uncontrolled infections - You have recently received other experimental drugs - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNMS-03597812

Route of Administration: Oral


Locations(7)

City of Hope - Duarte

Duarte, California, United States

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

Medical Oncology Hematology Consultants

Newark, Delaware, United States

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, United States

Mayo Clinic Cancer Center (MCCC) - Rochester

Rochester, Minnesota, United States

Gabrail Cancer Research Center

Canton, Ohio, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06549790


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