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NCT06366789 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of AML With Gene Mutations, sponsored by Lomond Therapeutics Holdings.

Recruiting
Registry status
Phase 1
Development phase
150
Enrollment target
20
Study locations

NCT06366789 is a Phase 1 study of AML With Gene Mutations that is actively recruiting participants, run by Lomond Therapeutics Holdings. The registered enrollment target is 150 participants. The trial reports 20 study locations across 14 states.

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The verdict

NCT06366789, a Phase 1 study of AML With Gene Mutations, is actively recruiting participants, sponsored by Lomond Therapeutics Holdings.

RECRUITING
Registry status
Phase 1
Development phase
150 participants
Enrollment target
20
Study locations

Study Summary

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

Conditions Studied

Interventions

  • DRUG ZE46-0134

Study Locations (20)

Other

  • Korea University Anam Hospital - Seoul
  • Seoul National University Hospital - Seoul
  • The Catholic University of Korea Seoul St. Mary's Hospital - Seoul
  • Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare - New Taipei City

California

  • University of California, Los Angeles - Los Angeles
  • University of California, San Francisco - San Francisco

Ohio

  • University of Cincinnati - Cincinnati
  • The Ohio State University - Columbus

Victoria

  • The Alfred Hospital - Melbourne
  • Eastern Health - Box Hill Hospital - Melbourne

Georgia

  • Emory University - Atlanta

Illinois

  • The University of Chicago - Chicago

Kansas

  • University of Kansas - Lawrence

Maryland

  • University of Maryland - College Park

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2024-05-29
Est. Completion 2027-12
Phase Phase 1

Sponsor

Lomond Therapeutics Holdings

2 total trials

What the Registry Record Tells You About NCT06366789

The ClinicalTrials.gov registry entry for NCT06366789 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lomond Therapeutics Holdings, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with AML With Gene Mutations appearing as the primary indexed condition, and to 1 intervention - of which ZE46-0134 is the first listed.

NCT06366789 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Other, California, Ohio.

Frequently Asked Questions

What is clinical trial NCT06366789 about?

NCT06366789 is a clinical study titled "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". 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

What is the current status of trial NCT06366789?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2024-05-29. Estimated completion is 2027-12.

What conditions does trial NCT06366789 study?

This clinical trial studies the following conditions: AML With Gene Mutations.

What interventions are being tested in trial NCT06366789?

The interventions under investigation include: ZE46-0134 (DRUG).

Who is sponsoring clinical trial NCT06366789?

This trial is sponsored by Lomond Therapeutics Holdings, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06366789 being conducted?

This trial has 20 study locations across California, Georgia, Illinois, Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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