RecruitingPhase 1NCT06366789

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, 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)

Sponsor

Lomond Therapeutics Holdings, Inc.

Enrollment

150 participants

Start Date

May 29, 2024

Study Type

INTERVENTIONAL

Conditions

AML With Gene Mutations

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called ZE46-0134 in adults with a type of blood cancer called acute myeloid leukemia (AML) that has specific genetic mutations (in FLT3 or the spliceosome) and has returned or stopped responding to prior treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with AML that relapsed or did not respond to first-line treatment - Your cancer has a FLT3 mutation or a spliceosome mutation (SF3B1, SRSF2, U2AF1, or ZRSR2) - You have adequate organ function **You may NOT be eligible if...** - You have certain other active cancers or serious heart conditions - You have received specific prior treatments that conflict with this study - You are pregnant or breastfeeding - Your cancer has spread to the brain or spinal fluid Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZE46-0134

oral capsules QD

Locations(23)

University of California, Los Angeles

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

Emory University

Atlanta, Georgia, United States

The University of Chicago

Chicago, Illinois, United States

University of Kansas

Lawrence, Kansas, United States

University of Maryland

College Park, Maryland, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

The Alfred Hospital

Melbourne, Victoria, Australia

Eastern Health - Box Hill Hospital

Melbourne, Victoria, Australia

Linear Clinical Research Ltd

Perth, Western Australia, Australia

Gachon University Gil Medical Center

Incheon, Gyeonggi-do, South Korea

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, South Korea

Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare

New Taipei City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Taichung Veterans General Hospital

Xitun, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06366789

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