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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05735184
Other study ID # KO-MEN-007
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date July 18, 2023
Est. completion date May 2027

Study information

Verified date May 2024
Source Kura Oncology, Inc.
Contact Clinical Operations
Phone 858 500 8800
Email KO-MEN-007@kuraoncology.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This Phase 1 study will assess the safety, tolerability, and preliminary antileukemic activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and 7+3 for two different molecularly-defined arms, NPM1-m and KMT2A-r.


Recruitment information / eligibility

Status Recruiting
Enrollment 212
Est. completion date May 2027
Est. primary completion date May 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: - Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed/refractory AML - 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 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 adequate contraception from the time of screening through 90 days following the last dose of study intervention Key Exclusion Criteria: - Diagnosis of either acute promyelocytic leukemia or blast chronic myelomonocytic leukemia - Known history of BCR-ABL alteration - Advanced malignant hepatic tumor [for patients receiving ven/aza combination] - 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 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 to control leukocytosis, prior treatment with all-transretinoic acid for initially suspected acute promyelocytic leukemia, or non-HMA therapy for prior myelodysplastic syndrome - 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 corrected QT interval corrected for heart rate by Fredericia's formula (QTcF) >480 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

Study Design


Intervention

Drug:
Ziftomenib
Oral Administration
Venetoclax
Oral Administration
Azacitidine
Subcutaneous or Intravenous Administration
Daunorubicin
Intravenous Administration
Cytarabine
Intravenous Administration

Locations

Country Name City State
United States UC Health Blood Disorders and Cell Therapies Center - Anschutz Medical Campus Aurora Colorado
United States Sarah Cannon Research Institute - St. David's South Austin Medical Center / Texas Oncology South Austin Austin Texas
United States Massachusetts General Hospital Boston Massachusetts
United States Roswell Park Comprehensive Cancer Center Buffalo New York
United States Robert H. Lurie Comprehensive Cancer Center of Northwestern University Chicago Illinois
United States Cleveland Clinic Cleveland Ohio
United States UT Southwestern - Simmons Cancer Center Dallas Texas
United States Colorado Blood Cancer Institute Denver Colorado
United States Karmanos Cancer Institute Detroit Michigan
United States Duke Blood Cancer Center Durham North Carolina
United States The University of Kansas Cancer Center Fairway Kansas
United States MD Anderson Cancer Center Houston Texas
United States Ochsner MD Anderson Cancer Center Jefferson Louisiana
United States Moores UC San Diego Cancer Center La Jolla California
United States UCLA - Bowyer Oncology Center Los Angeles California
United States USC University of Southern California / Norris Comprehensive Cancer Center Los Angeles California
United States Norton Cancer Institute - St. Matthews Louisville Kentucky
United States UW Health - Carbone Cancer Center Madison Wisconsin
United States University of Minnesota Minneapolis Minnesota
United States TriStar Bone Marrow Transplant Nashville Tennessee
United States Rutgers Cancer Institute New Brunswick New Jersey
United States Yale Cancer Center and Smilow Cancer Hospital New Haven Connecticut
United States Mount Sinai - Ruttenberg Treatment Center New York New York
United States New York - Presbyterian / Weill Cornell Medicine New York New York
United States OU Health Stephenson Cancer Center Oklahoma City Oklahoma
United States UCI Health Chao Family Comprehensive Cancer Center Orange California
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Stony Brook Cancer Center Stony Brook New York

Sponsors (1)

Lead Sponsor Collaborator
Kura Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of dose limiting toxicities (DLTs) per dose level Assessed by the NCI-CTCAE v5.0 During the first 28 days of ziftomenib in combination with SOC backbone treatment (1 cycle)
Primary Descriptive statistics of adverse events Assessed by the NCI-CTCAE v5.0 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
Primary Complete remission (CR) rate Assessed by the ELN 2022 criteria Up to 1 year following end of treatment with ziftomenib
Secondary Composite Complete Remission (CRc) or MLFS rate Assessed by the ELN 2022 criteria Up to 1 year following end of treatment with ziftomenib
Secondary Measurable residual disease (MRD) Assessed by multiparameter flow cytometry (MFC) and molecular analysis Up to 1 year following end of treatment with ziftomenib
Secondary Median OS To assess overall survival of ziftomenib Up to 1 year following end of treatment with ziftomenib
Secondary Proportion of patients alive To assess proportion of patients alive at 1 year following treatment with ziftomenib 1 year following end of treatment with ziftomenib
Secondary Median EFS To assess median event free survival Up to 1 year following end of treatment with ziftomenib
Secondary EFS To assess event free survival 1 year following end of treatment with ziftomenib
Secondary Median DOR To assess median duration of remission Up to 1 year following end of treatment with ziftomenib
Secondary Proportion of patients who undergo HSCT To assess proportion of patients who undergo hematopoietic stem cell transplant Up to 1 year following end of treatment with ziftomenib
Secondary TI To assess rate of transfusion independence Up to 1 year following end of treatment with ziftomenib
Secondary Cmax Maximum plasma concentration (Cmax) of ziftomenib and metabolites Cycle 1. Each cycle is 28 days.
Secondary Tmax Time to maximum plasma concentration (Tmax) of ziftomenib and metabolites Cycle 1. Each cycle is 28 days.
Secondary AUC0-last Area under the concentration-time curve from time zero to the time of the last quantifiable concentration after dosing (AUC0-last) of ziftomenib and metabolites Cycle 1. Each cycle is 28 days.
Secondary AUCtau Area under the concentration-time curve over a dosing interval (AUCtau) of ziftomenib Cycle 1. Each cycle is 28 days.
Secondary Accumulation ratio of ziftomenib and metabolites To assess accumulation ratio of ziftomenib and metabolites Cycle 1. Each cycle is 28 days.
Secondary Cmax of venetoclax Maximum plasma concentration (Cmax) of venetoclax Cycle 1. Each cycle is 28 days.
Secondary Tmax of venetoclax Time to maximum plasma concentration (Tmax) of venetoclax Cycle 1. Each cycle is 28 days.
Secondary AUC0-last of venetoclax Area under the concentration-time curve from time zero to the time of the last quantifiable concentration after dosing (AUC0-last) of venetoclax Cycle 1. Each cycle is 28 days.
Secondary AUCtau of venetoclax Area under the concentration-time curve over a dosing interval (AUCtau) of venetoclax Cycle 1. Each cycle is 28 days.
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