MedTrace Logo

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 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2026-03-13

No results posted yet for this 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.

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

Sponsors & Collaborators

  • Kura Oncology, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-18
Primary Completion
2030-04-30
Completion
2030-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05735184 on ClinicalTrials.gov