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RECRUITING

NCT05735184

PHASE1

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

Sponsor: Kura Oncology, Inc.

View on ClinicalTrials.gov

Summary

Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations. 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.

Official title: Phase 1 Study of Venetoclax/Azacitidine or Venetoclax in Combination With Ziftomenib or Standard Induction Cytarabine/Daunorubicin (7+3) Chemotherapy in Combination With Ziftomenib for the Treatment of Patients With Acute Myeloid Leukemia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

420

Start Date

2023-07-18

Completion Date

2030-04

Last Updated

2026-03-13

Healthy Volunteers

Conditions

Acute Myeloid Leukemia Mixed Lineage Leukemia Gene Mutation Refractory AML AML With Mutated NPM1 Acute Myeloid Leukemia Recurrent Acute Myeloid Leukemia, in Relapse NPM1 Mutation KMT2Ar Myeloid Sarcoma Nucleophosmin 1-mutated Acute Myeloid Leukemia

Interventions

DRUG

Ziftomenib

Oral Administration

DRUG

Venetoclax

Oral Administration

DRUG

Azacitidine

Subcutaneous or Intravenous Administration

DRUG

Daunorubicin

Intravenous Administration

DRUG

Cytarabine

Intravenous Administration

DRUG

Quizartinib

Oral Administration

Key Inclusion Criteria: * Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed/refractory AML * 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 Key Exclusion Criteria: * Diagnosis of either acute promyelocytic leukemia or blast phase chronic myeloid leukemia * 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

Locations (44)

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (44)