drugset / Trial / NCT06930352

Ziftomenib for the Treatment of Patients With NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia Not Eligible for Standard Therapy

NCT06930352

Phase 2 Not yet recruiting 70 enrolled Uma Borate Kura Oncology, Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

This phase II trial tests how well ziftomenib works in treating patients with NPM1 mutated or KMT2A rearranged acute myeloid leukemia (AML) and are not eligible to receive standard therapy. AML is often due to genetic changes in the cancer cells, including mutations in the NPM1 gene and rearrangements involving the KMT2A gene. These mutations result in activation of the menin pathway. Menin is a type of protein in the body that helps to regulate some of the naturally occurring processes in the body, but can also be involved in some types of cancers. Ziftomenib blocks this menin pathway and may prevent the cancer cells from continuing to grow. Giving ziftomenib may kill more cancer cells in patients with NPM1 mutated or KMT2A rearranged AML that are not eligible to receive standard therapy.

Timeline

Start
2026-09-10
Primary completion
2027-12-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ziftomenib Small molecule Oral
Background Cytarabine Small molecule
Background Hydroxyurea Other / unclassified