Clinical Trial

First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia

Active, Not Recruiting Phase 1/2
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Summary
In this trial, ziftomenib, a menin-MLL(KMT2A) inhibitor, will be tested in patients for the first time. The trial includes a Main Study and four sub-studies. In the Main Study (including Phase 1a, Phase 1b, and Phase 2 portions), ziftomenib will be evaluated in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML). The main study has completed enrollment. In Sub-studies 1 and 2, the effects of taking ziftomenib and other common drugs at the same time will be investigated in AML patients. In Sub-study 3, ziftomenib will be evaluated in patients with R/R acute lymphoblastic leukemia (ALL). In Sub-study 4, ziftomenib will be evaluated in patients with R/R AML with certain genetic mutations.
Protocol Amendment History 2 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-05-14
notable Trial sites reduced: 56 -> 43 locations 2026-05-14
Trial Details
NCT Number NCT04067336
Lead Sponsor Kura Oncology, Inc.
Conditions Advanced Malignant Neoplasm, Acute Myeloid Leukemia, Mixed Lineage Leukemia, Mixed Lineage Acute Leukemia, Acute Leukemia of Ambiguous Lineage, Mixed Phenotype Acute Leukemia, Acute Lymphoblastic Leukemia
Enrollment 263 participants
Start Date 2019-09-12
Primary Completion 2028-10-16 (estimated)
Study Completion 2028-10-16 (estimated)
Updated on ClinicalTrials.gov 2026-05-13