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Recruiting Phase 1 Interventional

Dose Escalation and Expansion Study to Evaluate the Safety, PK, PD and Efficacy of ZE46-0134 in Adults With FLT3 Mutated or Spliceosome Mutated Relapsed or Refractory Acute Myeloid Leukemia

ClinicalTrials.gov ID: NCT06366789

Public ClinicalTrials.gov record NCT06366789. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Nov 6, 2026, 7:03 AM EST

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Official title

A Phase 1, Open-label, Dose Escalation and Dose Expansion, Multicenter Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ZE46-0134 in Adults With FLT3 Mutated or Spliceosome Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of ZE46-0134 in patients with FLT3 and spliceosome mutated Relapsed or Refractory Acute Myeloid Leukemia

Study identification

NCT ID
NCT06366789
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1
Enrollment
150 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 29, 2024 (Actual)
Primary completion
Jan 2026 (Estimated)
Completion
Dec 2027 (Estimated)
Last update posted
Dec 31, 2025

2024 – 2027

United States locations

U.S. sites
12
U.S. states
10
U.S. cities
12
Facility City State ZIP Site status
University of California, Los Angeles Los Angeles California 90095 Recruiting
University of California, San Francisco San Francisco California 94143 Recruiting
Emory University Atlanta Georgia 30322 Recruiting
The University of Chicago Chicago Illinois 60637 Recruiting
University of Kansas Lawrence Kansas 66160 Recruiting
University of Maryland College Park Maryland 20742 Recruiting
Memorial Sloan Kettering Cancer Center New York New York 10065 Recruiting
University of North Carolina Chapel Hill North Carolina 27514 Recruiting
University of Cincinnati Cincinnati Ohio 45219 Recruiting
The Ohio State University Columbus Ohio 43210 Recruiting
Oregon Health & Science University Portland Oregon 97239 Recruiting
The University of Texas Southwestern Medical Center Dallas Texas 75390 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06366789, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 31, 2025 · Synced Nov 6, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06366789 live on ClinicalTrials.gov.

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