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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: Recruiting Phase 1 study of AML With Gene Mutations, sponsored by Lomond Therapeutics Holdings.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (150% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
To determine the maximum tolerated dose or biologically effective dose of ZE46-0134 in adults with FLT3 and spliceosome mutated relapsed and refractory AML.
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
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-05-29 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What NCT06366789 shows while recruiting
NCT06366789 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (150% higher).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for AML With Gene Mutations
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06366789's enrollment target sits among peer trials
150 363rd of 2000 higher than 1,620 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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