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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 ZE46-0134 for specific types of advanced leukemia.

Recruiting
18 years and older
All
Phase 1
This study looks at a treatment called **ZE46-0134** for adults with a type of blood cancer called *Acute Myeloid Leukemia (AML)*. Some people with AML have specific mutations (changes in their genes) like *FLT3* or *spliceosome mutations*. This study is in **Phase 1**, meaning it is an early stage to test safety and how the body processes the drug. The study has two parts: 1. **Dose Escalation**: Testing different amounts of the drug to find the safest dose. 2. **Dose Expansion**: More people get the safest dose to see how well it works. - **Participation Time**: Up to 24 cycles (28 days each) of treatment, with a possibility of more if beneficial. - **Visits**: Frequent visits for monitoring and treatment. - **Risks/Benefits**: Possible side effects, but a chance to find a new effective treatment for AML. Before joining, patients must meet certain conditions, like having specific mutations and being over 18. It's important to discuss this with your doctor to understand the potential risks and benefits.
Study details
    AML With Gene Mutations

NCT06366789

Lomond Therapeutics Holdings, Inc.

7 March 2026

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