A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, or 7+3 in Patients With AML

Launched by KURA ONCOLOGY, INC. · Feb 9, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called ziftomenib when used together with other medications for patients with a type of blood cancer known as acute myeloid leukemia (AML). The study aims to find out how safe the combination is and how well it works, especially in patients who have specific genetic changes in their cancer, such as NPM1 mutations or KMT2A rearrangements. The trial is currently recruiting participants who are between the ages of 65 and 74 and meet certain health criteria.

To be eligible for this trial, patients must have a confirmed diagnosis of AML with one of the targeted genetic mutations and cannot have certain other blood cancers or serious infections. Participants can expect to receive the study medication and undergo regular monitoring to check their health and how they are responding to treatment. It’s important for potential participants, especially women and men of childbearing age, to understand that they will need to use contraception during the trial to prevent pregnancy. If you or a loved one is interested in participating, discussing this with a healthcare provider can provide more personalized information.

Gender

ALL

Eligibility criteria

• 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