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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

NCT06366789 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-12-31

No results posted yet for this 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

  • AML With Gene Mutations

Interventions

DRUG

ZE46-0134

oral capsules QD

Sponsors & Collaborators

  • Lomond Therapeutics Holdings, Inc.

    lead INDUSTRY

Principal Investigators

  • Carolyn Grove, Prof · Linear Clinical Research

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-29
Primary Completion
2026-01-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • South Korea
  • Taiwan

Study Locations

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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 NCT06366789 on ClinicalTrials.gov