drugset / Trial / NCT07411586
Phase 1/1b Trial Of Olutasidenib And Ziftomenib For NPM1 And IDH1 Co-Mutated Acute Myeloid Leukemia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olutasidenib | Small molecule | 150 mg | Oral |
| Subject | Ziftomenib | Small molecule | — | Oral |