Recruiting
Phase 1

Ziftomenib, FLAG-IDA, Low-Dose Cytarabine, Gilteritinib

Sponsor:

Kura Oncology, Inc.

Code:

NCT06001788

Conditions

AML

AML With Mutated NPM1

Hematologic Malignancy

KMT2Ar

NPM1 Mutation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ziftomenib

Fludarabine

Idarubicin

Cytarabine

Gilteritinib

Study Details

Brief summary:

The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.

Conditions

AML

AML With Mutated NPM1

Hematologic Malignancy

KMT2Ar

NPM1 Mutation

Study ID

NCT06001788

Start date

Feb 22, 2024

Status verified date

Aug, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Has been diagnosed with relapsed/refractory AML.
  • Has a documented NPM1 mutation or KMT2A rearrangement.
  • Has a documented FLT3 mutation (cA-3 only).
  • Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.
  • Has adequate hepatic and renal function as defined per protocol.
  • Has an ejection fraction above a protocol defined limit.
  • Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.
  • Has agreed to use contraception as defined per protocol.

Key Exclusion Criteria:

  • Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.
  • Has clinically active central nervous system leukemia.
  • Has an active and uncontrolled infection.
  • Has a mean corrected QT interval (QTcF) > 480ms.
  • Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.
  • Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy <14 days or within 5 drug half-lives prior to the first dose of study intervention.
  • Has had major surgery within 4 weeks prior to the first dose of study intervention.
  • Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria.
  • Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD
  • Participant is pregnant or lactating.

Study Design

Enrollment

171 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a

Oral ziftomenib; sequential cohorts of escalating dose levels of ziftomenib to identify the safety and tolerability of the combination regimens. Participants will be enrolled in 1 of 5 dose escalation cohorts:

A-1: Participants with a NPM1 mutation: ziftomenib plus FLAG-IDA

A-2: Participants with a NPM1 mutation: ziftomenib plus low-dose cytarabine (LDAC)

A-3: Participants with a NPM1 mutation: ziftomenib plus gilteritinib

B-1: Participants with a KMT2A rearrangement: ziftomenib plus FLAG-IDA

B-2: Participants with a KMT2A rearrangement: ziftomenib plus low-dose cytarabine (LDAC)

experimental: Phase 1b

Oral ziftomenib; Following the determination of the maximum tolerated dose in Phase 1a, participants will be enrolled in 1 of 5 dose validation/expansion cohorts:

A-1: Participants with a NPM1 mutation: ziftomenib plus FLAG-IDA

A-2: Participants with a NPM1 mutation: ziftomenib plus low-dose cytarabine (LDAC)

A-3: Participants with a NPM1 mutation: ziftomenib plus gilteritinib

B-1: Participants with a KMT2A rearrangement: ziftomenib plus FLAG-IDA

B-2: Participants with a KMT2A rearrangement: ziftomenib plus low-dose cytarabine (LDAC)

Interventions

Ziftomenib

Oral administration

Fludarabine

Intravenous infusion

Idarubicin

Intravenous infusion

Cytarabine

Intravenous Infusion

Gilteritinib

Oral administration

Granulocyte colony-stimulating factor

Subcutaneous injection

Primary outcome measure

  • Rate of dose limiting toxicities (DLTs) per dose level [ Time Frame: During the first 28 days of ziftomenib in combination with SOC treatment (1 cycle) ]
  • Descriptive statistics of adverse events [ Time Frame: First dose of ziftomenib up to and including 28 days after last dose of ziftomenib, or if the patient is lost to follow-up, whichever comes first ]

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

Contacts

480-256-6444BMDACCResearch@bannerhealth.com

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90089

Contacts

Christine Duran

323-865-0371duran_c@med.usc.edu

UCLA Health - Bowyer Oncology Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Bruck Habtemariam

310-794-0242bhabtemariam@mednet.ucla.edu

UC Irvine Health Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 92868

Contacts

Research Line

877-827-8839ucstudy@hs.uci.edu

University of California San Francisco

Recruiting

San Francisco, California, United States, 94115

Colorado Blood Cancer Institute

Recruiting

Denver, Colorado, United States, 80218

Contacts

New Patient Contact

720-754-4835PLSMDLCBCINewPatient@HCAHealthcare.com

Smilow Cancer Hospital at Yale New Haven

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Farah Fasihuddin

203-737-3472farah.fasihuddin@yale.edu

Emory Healthcare - The Emory Clinic

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Gigi Stoneback

gissela.blanco.stoneback@emory.edu

Georgia Cancer Center at Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Amanda Spires

amspires@augusta.edu

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

312-695-9367cancer@northwestern.edu

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Esteban Orozco Espiricueta

708-327-3221eespiricuetaorozco@luc.edu

University of Iowa Hospitals & Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Grerk Sutamtewagul

319-353-8383Grerk-sutamtewagul@uiowa.edu

The University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

KUCC Navigation Team

913-588-3671kucc_navigation@kumc.edu

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Henry Ford Cancer Institute

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Kristyn Dailey

KDailey6@hfhs.org

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

John Theurer Cancer Center at Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Oncology Clinical Reference Referral Office

551-996-1777OncologyResearchReferral@hmhn.org

Roswell Park Comprehensive Cancer Center

Recruiting

Buffalo, New York, United States, 14263

Contacts

877-275-7724askrpci@roswellpark.org

Northwell Health, LLC PRIME

Recruiting

Lake Success, New York, United States, 11042

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10021

Contacts

646-888-4167

Weill Cornell Medical College-NY Presbyterian Hospital

Recruiting

New York, New York, United States, 10065

Contacts

Tania Curcio

212-746-2571tjc9003@med.cornell.edu

Wilmot Cancer Institute, University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Clinical Trials Referral Office

855-776-0015wcictoresearch@urmc.rochester.edu

Stony Brook Cancer Center

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Zita Makselyte

zita.makselyte@stonybrookmedicine.edu

Atrium Health Levine Cancer Center

Recruiting

Charlotte, North Carolina, United States, 60201

Contacts

Chari Granger

Chari.Granger@atriumhealth.org

UH Seidman Cancer Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Leslie Ortega

216-844-8129ctgov@case.edu

OU Health Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Cynthia J Lowery

Cynthia-Lowery@ouhsc.edu

Prisma Health

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

Lisa Johnson

864-455-3735lisa.johnson@prismahealth.org

Fiona Davidson

864-455-3737fiona.davidson@prismahealth.org

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Recruitment and Eligibility Office

800-811-8480cip@vumc.org

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

Christine Terraciano

Christine.Terraciano@usoncology.com

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Ann Mosely

aemosley@mdanderson.org

University of Vermont

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Stephanie Stahl

802-656-2021Stephanie.Stahl@uvmhealth.org

University of Virginia Comprehensive Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Avani Hopkins

434-243-8108Ajh7jqe@uvahealth.org

University of Washington

Recruiting

Seattle, Washington, United States, 98109

Froedtert & Medical College Clinics

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Kura Oncology, Inc.

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

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.