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

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NCT05735184 · readout ≤ 1,350 d

Sponsored by Kura Oncology, Inc. (industry) · KURA — their whole pipeline →.

Phase

Phase 1

Status

Recruiting

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

420estimated

Sites

Country

United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2023-07-18

actual

When the study began enrolling

Primary completion

Apr 2030

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Apr 2030

estimated

The whole study's end, after follow-up

First posted

2023-02-21

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-03-13

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

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 — also filed as KO-539
Drug: Venetoclax — also filed as Venclexta, Venclyxto
Drug: Azacitidine — also filed as Azadine, Vidaza
Drug: Daunorubicin — also filed as Cerubidine, daunomycin
Drug: Cytarabine — also filed as cytosine arabinoside (ara-C), Cytosar-U, Tarabine PFS
Drug: Quizartinib — also filed as Vanflyta

Primary outcomes

what the primary-completion date above is the date OF

Rate of dose limiting toxicities (DLTs) per dose level (Part 1a only)

measured During the first 28 days of ziftomenib in combination with SOC backbone treatment (1 cycle)

Descriptive statistics of adverse events

measured From Cycle 1 Day 1 up to and including 28 days following the end of 36 months of treatment

Complete remission (CR) rate

measured Until relapse, new anti-cancer therapy, death, or up to 36 months of treatment, whichever occurs first

Publications

PMID 42227701 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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