A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML
NCT ID: NCT05735184
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
420 participants
INTERVENTIONAL
2023-07-18
2030-04-30
Brief Summary
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This protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in patients who have AML with certain genetic mutations. Both newly diagnosed and relapsed refractory patients with AML will be assigned to different cohorts based on specific study criteria and physician discretion.
The purpose of this study is to assess the safety, tolerability, and early signs of efficacy of ziftomenib in combination with SOC drugs to treat AML.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose Escalation: Ziftomenib with Venetoclax and Azacitidine in R/R NPM1-m (A-1)
Ziftomenib with Venetoclax and Azacitidine in relapsed/refractory NPM1-m AML patients who have failed at least one prior line of therapy
Ziftomenib
Oral Administration
Venetoclax
Oral Administration
Azacitidine
Subcutaneous or Intravenous Administration
Dose Validation/Expansion: Ziftomenib with Venetoclax and Azacitidine in R/R NPM1-m (A-1)
Ziftomenib with Venetoclax and Azacitidine in relapsed/refractory NPM1-m AML patients who have failed at least one prior line of therapy
Ziftomenib
Oral Administration
Venetoclax
Oral Administration
Azacitidine
Subcutaneous or Intravenous Administration
Dose Escalation: Ziftomenib with 7+3 in 1L NPM1-m/FLT3 wildtype (A-2)
Ziftomenib with 7+3 in newly diagnosed NPM1-m AML patients who are candidates for intensive chemotherapy and must be FLT3 wildtype or ITD ratio \<0.05
Ziftomenib
Oral Administration
Daunorubicin
Intravenous Administration
Cytarabine
Intravenous Administration
Dose Validation/Expansion: Ziftomenib with 7+3 in 1L NPM1-m/FLT3 wildtype (A-2)
Ziftomenib with 7+3 in newly diagnosed NPM1-m AML patients who are candidates for intensive chemotherapy and must be FLT3 wildtype or ITD ratio \<0.05
Ziftomenib
Oral Administration
Daunorubicin
Intravenous Administration
Cytarabine
Intravenous Administration
Dose Validation/Expansion: Ziftomenib with Venetoclax in R/R NPM1-m (A-3)
Ziftomenib with Venetoclax in relapsed/refractory NPM1-m AML patients who have failed at least one prior line of therapy
Ziftomenib
Oral Administration
Venetoclax
Oral Administration
Dose Validation/Expansion: Ziftomenib with Venetoclax and Azacitidine in 1L NPM1-m (A-4)
Ziftomenib with Venetoclax and Azacitidine in newly diagnosed NPM1-m AML patients
Ziftomenib
Oral Administration
Venetoclax
Oral Administration
Azacitidine
Subcutaneous or Intravenous Administration
Dose Escalation: Ziftomenib with Venetoclax and Azacitidine in R/R KMT2A-r (B-1)
Ziftomenib with Venetoclax and Azacitidine in relapsed/refractory KMT2A-r AML patients who have failed at least one prior line of therapy
Ziftomenib
Oral Administration
Venetoclax
Oral Administration
Azacitidine
Subcutaneous or Intravenous Administration
Dose Validation/Expansion: Ziftomenib with Venetoclax and Azacitidine in R/R KMT2A-r (B-1)
Ziftomenib with Venetoclax and Azacitidine in relapsed/refractory KMT2A-r AML patients who have failed at least one prior line of therapy
Ziftomenib
Oral Administration
Venetoclax
Oral Administration
Azacitidine
Subcutaneous or Intravenous Administration
Dose Escalation: Ziftomenib with 7+3 in 1L KMT2A-r (B-2)
Ziftomenib with 7+3 in newly diagnosed KMT2A-r AML patients who are candidates for intensive chemotherapy
Ziftomenib
Oral Administration
Daunorubicin
Intravenous Administration
Cytarabine
Intravenous Administration
Dose Validation/Expansion: Ziftomenib with 7+3 in 1L KMT2A-r (B-2)
Ziftomenib with 7+3 in newly diagnosed KMT2A-r AML patients who are candidates for intensive therapy
Ziftomenib
Oral Administration
Daunorubicin
Intravenous Administration
Cytarabine
Intravenous Administration
Dose Validation/Expansion: Ziftomenib with Venetoclax + Azacitidine in 1L KMT2A-r (B-3)
Ziftomenib with Venetoclax and Azacitidine in newly diagnosed KMT2A-r AML patients
Ziftomenib
Oral Administration
Venetoclax
Oral Administration
Azacitidine
Subcutaneous or Intravenous Administration
Dose Escalation: Ziftomenib with 7+3+quizartinib in 1L NPM1-m/FLT3-ITD+ AML patients (C-1)
Ziftomenib with 7+3 and quizartinib in newly diagnosed NPM1-m and FLT3-ITD+ (with allelic ratio ≥0.05) AML patients who are candidates for IC and eligible to receive FLT3-targeted therapy
Ziftomenib
Oral Administration
Daunorubicin
Intravenous Administration
Cytarabine
Intravenous Administration
Quizartinib
Oral Administration
Dose Validation/Expansion: Ziftomenib with 7+3+quizartinib in 1L NPM1-m/FLT3-ITD+ AML patients (C-1)
Ziftomenib with 7+3 and quizartinib in newly diagnosed NPM1-m and FLT3-ITD+ (with allelic ratio ≥0.05) AML patients who are candidates for IC and eligible to receive FLT3-targeted therapy
Ziftomenib
Oral Administration
Daunorubicin
Intravenous Administration
Cytarabine
Intravenous Administration
Quizartinib
Oral Administration
Interventions
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Ziftomenib
Oral Administration
Venetoclax
Oral Administration
Azacitidine
Subcutaneous or Intravenous Administration
Daunorubicin
Intravenous Administration
Cytarabine
Intravenous Administration
Quizartinib
Oral Administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Those intending treatment with intensive chemotherapy in Arm C should be NPM1-m and FLT3-ITD+ with an allelic ratio ≥0.05 and eligible for FLT3-targeted treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Adequate liver, renal, and cardiac function according to protocol defined criteria
* A female of childbearing potential must agree to use adequate contraception as well as a double barrier method from the time of screening through 180 days following the last dose of study intervention. A male of childbearing potential must agree to use abstinence or use a double barrier method of contraception from the time of screening through 180 days following the last dose of study intervention
* Female patients of childbearing potential who receive quizartinib in Arm C should use a highly effective method of contraception during quizartinib treatment and for 7 months after the last dose
Exclusion Criteria
* Known history of BCR-ABL alteration
* Advanced malignant hepatic tumor
* Administration of live attenuated vaccines within 14 days prior to, during, or after treatment until B-cell recovery
* Active central nervous system (CNS) involvement by AML.
* Clinical signs/symptoms of leukostasis or WBC \> 25,000 / microliter. Hydroxyurea and/or leukapheresis and/or up to 2 doses of cytarabine if used per institutional SOC for control of leukocytosis are permitted to meet this criterion
* Not recovered to Grade ≤1 (NCI-CTCAE v5.0) from all nonhematological toxicities except for alopecia
* Known clinically active human immunodeficiency virus, active hepatitis B or active hepatitis C infection
* For newly diagnosed cohorts: received prior chemotherapy for leukemia, except hydroxyurea and/or leukapheresis and/or up to 2 doses of cytarabine per institutional standards to control leukocytosis, or prior treatment with all-transretinoic acid for initially suspected acute promyelocytic leukemia
* For relapsed/refractory cohorts: received chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational \< 14 days prior to the first dose of ziftomenib or within 5 drug half-lives prior to the first dose of study drug
* Uncontrolled intercurrent illness including, but not limited to, cardiac illness as defined in the protocol
* Mean QT interval corrected for heart rate by Fredericia's formula (QTcF)
* Arm A and Arm B: \>480 ms on triplicate ECGs
* Arm C: \>450 ms on triplicate ECGs
* Uncontrolled infection
* Women who are pregnant or lactating
* An active malignancy and currently receiving chemotherapy for that malignancy or disease that is uncontrolled/progressing
* Patients who have active GVHD requiring \>0.5 mg/kg prednisone or any new or increase in immunosuppressants in the prior 2 weeks for GVHD treatment
18 Years
ALL
No
Sponsors
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Kura Oncology, Inc.
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic - Phoenix
Phoenix, Arizona, United States
Moores UC San Diego Cancer Center
La Jolla, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA - Bowyer Oncology Center
Los Angeles, California, United States
UC Irvine Health Chao Family Comprehensive Cancer Center
Orange, California, United States
University of Colorado
Aurora, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Yale Cancer Center and Smilow Cancer Hospital
New Haven, Connecticut, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Emory Healthcare - The Emory Clinic
Atlanta, Georgia, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
The University of Kansas Medical Center Research Institute
Fairway, Kansas, United States
University of Kentucky Markey Cancer Center
Louisville, Kentucky, United States
Norton Cancer Institute - St. Matthews
Louisville, Kentucky, United States
Ochsner MD Anderson Cancer Center
Jefferson, Louisiana, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
UMass Chan Medical School
Worcester, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
New York - Presbyterian / Weill Cornell Medicine
New York, New York, United States
Mount Sinai - Ruttenberg Treatment Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Duke Blood Cancer Center
Durham, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, United States
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
TriStar Bone Marrow Transplant
Nashville, Tennessee, United States
Sarah Cannon Research Institute - St. David's South Austin Medical Center / Texas Oncology South Austin
Austin, Texas, United States
UT Southwestern - Simmons Cancer Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Referral Office
Role: primary
Clinical Trials Referral Office
Role: primary
Role: primary
Role: primary
Role: primary
Clinical Trials Referral Office
Role: primary
Role: primary
Ask Sarah
Role: primary
Medical College of WI Cancer Center Clinical Trials Office
Role: primary
Other Identifiers
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KO-MEN-007
Identifier Type: -
Identifier Source: org_study_id
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