First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia
Running, not enrolling · Phase 1/Phase 2
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT04067336
- Run by
- Kura Oncology, Inc.
- People needed
- 263
- Starts
- 2019-09-12
- Expected to finish
- 2028-10-16
- Last updated by the study team
- 2026-05-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
- UCLA Ronald Reagan Medical Center — Los Angeles, California, United States
- Mayo Clinic — Jacksonville, Florida, United States
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois, United States
- University of Maryland Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- University of Michigan Hospitals — Ann Arbor, Michigan, United States
- Karmanos Cancer Institute — Detroit, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Hackensack University Medical Center - John Theurer Cancer Center — Hackensack, New Jersey, United States
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States
- Weill Cornell Medical College - NY Presbyterian Hospital — New York, New York, United States
- The Mount Sinai Hospital — New York, New York, United States
- Duke Cancer Institute — Durham, North Carolina, United States
- Oklahoma University Health - Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
- Harold C. Simmons Comprehensive Cancer Center - UT Southwestern Medical Center — Dallas, Texas, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
- AZ Delta - Campus Rumbeke — Roeselare, Belgium
- Queen Elizabeth II Health Sciences Centre — Halifax, Nova Scotia, Canada
- Hopital Maisonneuve-Rosemont — Montreal, Quebec, Canada
- Hopital de l'Enfant-Jesus - Centre Integre en Cancerologie du CHU de Quebec - Universite Laval — Québec, Quebec, Canada
- Centre Hospitalier Universitaire de Lille — Lille, France
Full record on ClinicalTrials.gov
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