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 Jul 22, 2026, 3:29 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Study identification

NCT ID: NCT06366789
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: Lomond Therapeutics Holdings, Inc.; Industry
Enrollment: 150 participants

Conditions and interventions

Conditions

AML With Gene Mutations

Interventions

ZE46-0134 Drug

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 28, 2024
Primary completion: Dec 31, 2025
Completion: Nov 30, 2027
Last update posted: Dec 30, 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 30, 2025 · Synced Jul 22, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06366789 live on ClinicalTrials.gov.

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