🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT05735184
Recruiting Phase 1

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

NCT05735184 · tracked via the Priya Life Science USA tracker
Sponsor
Kura Oncology, Inc.
Phase
Phase 1
Started
2023-07-18
Last updated
2026-03-13

Condition(s) studied

Acute Myeloid LeukemiaMixed Lineage Leukemia Gene MutationRefractory AMLAML With Mutated NPM1Acute Myeloid Leukemia RecurrentAcute Myeloid Leukemia, in RelapseNPM1 MutationKMT2ArMyeloid SarcomaNucleophosmin 1-mutated Acute Myeloid Leukemia

Investigational drug(s) / intervention(s)

ZiftomenibVenetoclaxAzacitidineDaunorubicinCytarabineQuizartinib

Ziftomenib: Oral Administration

Venetoclax: Oral Administration

Azacitidine: Subcutaneous or Intravenous Administration

Daunorubicin: Intravenous Administration

Cytarabine: Intravenous Administration

Quizartinib: Oral Administration

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (44)

FacilityCityRegionStatus
Mayo Clinic - Phoenix Phoenix Arizona Recruiting
Moores UC San Diego Cancer Center La Jolla California Recruiting
USC / Norris Comprehensive Cancer Center Los Angeles California Recruiting
UCLA - Bowyer Oncology Center Los Angeles California Recruiting
UC Irvine Health Chao Family Comprehensive Cancer Center Orange California Recruiting
University of Colorado Aurora Colorado Recruiting
Colorado Blood Cancer Institute Denver Colorado Recruiting
Yale Cancer Center and Smilow Cancer Hospital New Haven Connecticut Recruiting
Mayo Clinic Jacksonville Jacksonville Florida Recruiting
Emory Healthcare - The Emory Clinic Atlanta Georgia Recruiting
Georgia Cancer Center at Augusta University Augusta Georgia Recruiting
Robert H. Lurie Comprehensive Cancer Center of Northwestern University Chicago Illinois Recruiting
Loyola University Medical Center Maywood Illinois Recruiting
University of Iowa Hospitals & Clinics Iowa City Iowa Recruiting
The University of Kansas Medical Center Research Institute Fairway Kansas Recruiting
University of Kentucky Markey Cancer Center Louisville Kentucky Recruiting
Norton Cancer Institute - St. Matthews Louisville Kentucky Recruiting
Ochsner MD Anderson Cancer Center Jefferson Louisiana Recruiting
Johns Hopkins School of Medicine Baltimore Maryland Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
UMass Chan Medical School Worcester Massachusetts Recruiting
University of Michigan Comprehensive Cancer Center Ann Arbor Michigan Recruiting
Karmanos Cancer Institute Detroit Michigan Recruiting
University of Minnesota Minneapolis Minnesota Recruiting
Mayo Clinic - Rochester Rochester Minnesota Recruiting
Hackensack University Medical Center Hackensack New Jersey Recruiting
Rutgers Cancer Institute New Brunswick New Jersey Recruiting
Roswell Park Comprehensive Cancer Center Buffalo New York Recruiting
New York - Presbyterian / Weill Cornell Medicine New York New York Recruiting
Mount Sinai - Ruttenberg Treatment Center New York New York Recruiting
Columbia University Medical Center New York New York Recruiting
Stony Brook University Hospital Stony Brook New York Recruiting
Duke Blood Cancer Center Durham North Carolina Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting
Cleveland Clinic Taussig Cancer Institute Cleveland Ohio Recruiting
The James Cancer Hospital and Solove Research Institute Columbus Ohio Recruiting
OU Health Stephenson Cancer Center Oklahoma City Oklahoma Recruiting
Hospital of the University of Pennsylvania Philadelphia Pennsylvania Recruiting
TriStar Bone Marrow Transplant Nashville Tennessee Recruiting
Sarah Cannon Research Institute - St. David's South Austin Medical Center / Texas Oncology South Austin Austin Texas Recruiting

+ 4 more sites — see the full list on the official registry below.

On this site

📄 Venclexta (venetoclax) drug profile →

More Kura Oncology, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05735184 on ClinicalTrials.gov ↗ ← All trials in the USA