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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

Study testing safety and effects of ZE46-0134 for specific leukemia types.

Recruiting
18 years and older
All
Phase 1

This study is for adults with a type of blood cancer called Acute Myeloid Leukemia (AML). AML is a cancer where blood cells grow quickly and take over the bone marrow. This study is testing a new treatment called ZE46-0134 for patients whose AML has come back or didn't get better with regular treatment. It focuses on patients with specific genetic changes (mutations) called FLT3 or spliceosome mutations.

The study has two parts. In Part 1, patients will try different doses to find the best safe amount. Part 2 will use information from Part 1 to test the best dose in more people. Each cycle of treatment is 28 days long, and patients can get up to 24 cycles if they benefit from the treatment.

  • The study lasts for up to 24 cycles, with each cycle being 28 days.
  • Eligible patients must be 18 years or older and have specific mutations.
  • Participants need to have a life expectancy of at least 3 months.
Study details
    AML With Gene Mutations

NCT06366789

Lomond Therapeutics Holdings, Inc.

19 September 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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