drugset / Trial / NCT07411586

Phase 1/1b Trial Of Olutasidenib And Ziftomenib For NPM1 And IDH1 Co-Mutated Acute Myeloid Leukemia

NCT07411586

Phase 1 Not yet recruiting 20 enrolled M.D. Anderson Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

The goal of Phase 1 is to find the recommended dose of ziftomenib and olutasidenib in patients with relapsed/refractory AML that has a mutation in the NPM1 and IDH1 genes. The goal of Phase 1b is to learn if the recommended dose of ziftomenib and olutasidenib found in Phase 1 can help to control the disease. The safety and effects of this combination will also be studied in both parts.

Timeline

Start
2026-08-31
Primary completion
2027-01-14
Completion
2029-01-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Olutasidenib Small molecule 150 mg Oral
Subject Ziftomenib Small molecule Oral