Recruiting

Phase 3

ZiftomenibStudies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML

Sponsor:

Kura Oncology, Inc.

Code:

NCT07007312

Conditions

Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ziftomenib

Placebo

Venetoclax

Azacitidine (AZA)

Daunorubicin

Study Details

Brief summary:

Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with eligible genetic alterations. Ziftomenib is a type of therapy known to target the menin pathway in cancer cells.

This protocol has 2 separate studies that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) AML treatments in patients with certain genetic mutations who have not received any treatment for their AML. In the first study, the Nonintensive Therapy Study, older patients or those with serious medical problems will receive the SOC therapies venetoclax (ven) and azacitidine (aza), plus either ziftomenib or a placebo. In the second study, the Intensive Therapy Study, medically fit patients will receive (a) the SOC therapies cytarabine and daunorubicin, plus either ziftomenib or a placebo during a first treatment phase called induction, (b) cytarabine plus either ziftomenib or a placebo during a second treatment phase called consolidation, and (c) ziftomenib or a placebo during a third treatment phase called maintenance.

The physician will determine which study is the appropriate treatment for the patient, but neither the patient nor their physician will know whether the patient has been assigned to receive ziftomenib or a placebo. This design is called "double-blinded".

Conditions

Acute Myeloid Leukemia (AML)

Study ID

NCT07007312

Start date

Sep 26, 2025

Status verified date

Aug, 2026

Completion date

Nov, 2031

Anticipated

Primary completion date

Nov, 2031

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

The following criteria apply to both the Nonintensive Therapy Study and the Intensive Therapy Study unless otherwise noted:

Age ≥18 years at time of signing the informed consent form.
Diagnosis of AML per the 2022 WHO Classification of Hematolymphoid Tumors (5th Edition).
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Adequate liver and kidney function according to protocol requirements.
A female of childbearing potential must agree to use adequate contraception from the time of screening through 180 days following the last dose of study intervention. A male with a female partner of childbearing potential must agree to use abstinence or adequate contraception from the time of screening through 90 days following the last dose of study intervention.
NONINTENSIVE THERAPY STUDY ONLY (VEN+AZA):

1. Documented NPM1-m.
2. Patients considered ineligible for Intensive Therapy defined by the following:

i. Age ≥75, OR
ii. Age <75 with an ECOG performance status of 2 or cardiac, renal, or hepatic impairment per protocol criteria.
INTENSIVE THERAPY STUDY ONLY (7+3):

1. Documented NPM1-m or KMT2A-r (KMT2A-r patients with a partial tandem duplication are not eligible).
2. Documented FLT3 wild-type or ITD ratio <0.05 OR ineligible to receive FLT3-targeted therapy (medically ineligible or mutation in which FLT3 inhibition is not SOC). Lack of access to an FLT3 inhibitor is not considered "ineligible" for FLT3-targeted therapy.
3. Ejection fraction of ≥50%.
4. Fit for Intensive Therapy per Investigator opinion.

Key Exclusion Criteria:

Prior therapy for AML (except hydroxyurea or leukapheresis for WBC control).
Diagnosis of acute promyelocytic leukemia (APL), blast phase chronic myeloid leukemia, or isolated myeloid sarcoma.
Known history of BCR-ABL mutation.
History of other active concurrent malignancies prior to study entry except:

1. Basal cell skin cancer or localized squamous cell cancer of the skin
2. Previous malignancy confined and locally resected (or treated with other modalities) with curative intent
3. Prostate or breast cancer receiving adjuvant hormonal therapy.

Active central nervous system (CNS) involvement by AML.
Clinical signs/symptoms of leukostasis or white blood cells (WBC) >25×10\^9/L prior to start of ziftomenib/placebo. Note: Hydroxyurea and/or leukapheresis are permitted to meet this criterion.
Known uncontrolled HIV infection or known active hepatitis B virus, hepatitis C virus infection, or other uncontrolled infection.
Uncontrolled intercurrent illness including but not limited to, cardiac illness as defined in the protocol.
Women who are pregnant or lactating.

Study Design

Enrollment

1300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nonintensive Therapy Study, Arm A

Ziftomenib in combination with venetoclax+azacitidine

placebo comparator: Nonintensive Therapy Study, Arm B

Placebo in combination with venetoclax+azacitidine

experimental: Intensive Therapy Study, Arm A

Ziftomenib+cytarabine+daunorubicin (induction), ziftomenib+cytarabine (consolidation), ziftomenib (maintenance)

experimental: Intensive Therapy Study, Arm B

Ziftomenib+cytarabine+daunorubicin (induction), ziftomenib+cytarabine (consolidation), placebo (maintenance)

placebo comparator: Intensive Therapy Study, Arm C

Placebo+cytarabine+daunorubicin (induction), placebo+cytarabine (consolidation), placebo (maintenance)

Interventions

Ziftomenib

Oral administration

Placebo

Oral administration

Venetoclax

Oral administration

Azacitidine (AZA)

Intravenous or subcutaneous administration

Daunorubicin

Intravenous administration

Cytarabine (Ara-C)

Intravenous administration

Primary outcome measure

Nonintensive Therapy Study: (Primary Endpoint for all countries): Overall survival (OS) [ Time Frame: Defined as the time from randomization to date of death from any cause, assessed up to 36 months after last patient inclusion ]
Nonintensive Therapy Study: (Dual Primary Endpoint for US & US reference countries only): Complete remission (CR) [ Time Frame: Assessed up to 36 months after last patient inclusion ]
Intensive Therapy Study: (Primary Endpoint for all countries): Event-free survival (EFS) [ Time Frame: Defined as the time from randomization to treatment failure, hematologic relapse following CR, or death from any cause, whichever comes first, assessed up to 36 months after last patient inclusion ]
Intensive Therapy Study: (Dual Primary Endpoint for US & US reference countries only): Complete remission (CR) with bone marrow (BM) measurable residual disease (MRD) negativity in NPM1-m patients [ Time Frame: Assessed up to 36 months after last patient inclusion ]

Central Contacts and Locations

Central contacts

Kura Medical Information

844-KURAONC (844-587-2662)medinfo@kuraoncology.com

Locations

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

University of California, Fresno

Recruiting

Clovis, California, United States, 93611

University of California, San Diego

Recruiting

La Jolla, California, United States, 92093

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

University of California, Irvine

Recruiting

Orange, California, United States, 92868

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Colorado Blood Cancer Institute

Recruiting

Denver, Colorado, United States, 80218

Hartford HealthCare Cancer Institute

Recruiting

Hartford, Connecticut, United States, 06106

Yale University School of Medicine

Recruiting

New Haven, Connecticut, United States, 06510

University of Miami

Recruiting

Miami, Florida, United States, 33136

Moffitt Cancer Center & Research Institute

Recruiting

Tampa, Florida, United States, 33612

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52246

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

University of Massachusetts

Recruiting

Worcester, Massachusetts, United States, 01605

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Wayne State University School of Medicine

Recruiting

Detroit, Michigan, United States, 48201

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Rutgers Biomedical and Health Sciences

Recruiting

New Brunswick, New Jersey, United States, 08903

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87131

State University of New York at Buffalo

Recruiting

Buffalo, New York, United States, 14263

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10003

Columbia University

Recruiting

New York, New York, United States, 10032

Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10065

University of North Carolina, Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Willamette Valley Cancer Institute

Recruiting

Eugene, Oregon, United States, 97401

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Baptist Clinical Research Institute

Recruiting

Memphis, Tennessee, United States, 38120

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

TriStar Centennial Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology-Austin Midtown

Recruiting

Austin, Texas, United States, 78705

Texas Oncology-Presbyterian Cancer Center

Recruiting

Dallas, Texas, United States, 75231

University of Texas

Recruiting

Houston, Texas, United States, 77030

Texas Oncology - San Antonio Medical Center

Recruiting

San Antonio, Texas, United States, 78240

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

University of Virginia School of Medicine

Recruiting

Charlottesville, Virginia, United States, 22903

Virginia Cancer Specialists

Recruiting

Manassas, Virginia, United States, 20110

WVU Medicine Wheeling Hospital

Recruiting

Wheeling, West Virginia, United States, 26003

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

Froedtert & Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Royal Victoria Hospital

Recruiting

Montreal, Quebec, Canada, H4A3J1

More Information

Sponsor

Kura Oncology, Inc.

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

AML
Hematological malignancy
KMT2A
NPM1
Menin
Acute Leukemia
Leukemia
Acute Myeloid Leukemia
Newly diagnosed AML
Newly diagnosed KMT2A-r AML
Newly diagnosed NPM1m AML
Untreated AML
Untreated NPM1m AML
Untreated KMT2A-r AML
MLL

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Kura Oncology, Inc. on 2026-08-20.