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A Phase 1 Study of STX-0712 in Patients With Advanced Hematological Malignancies (CMML and AML)

Study on the Safety and Efficacy of an Investigational Medication for Chronic Myelomonocytic Leukemia (CMML) and Acute Myeloid Leukemia (AML)

Recruiting
18 years and older
All
Phase 1

This study investigates the safety and early effects of an investigational medication in people with certain types of blood cancers, specifically chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML). CMML is a type of cancer that affects blood-forming cells in the bone marrow, while AML is a cancer of the blood and bone marrow with excess immature white blood cells. The study is being conducted to see how well the investigational medication works in people whose cancer has not responded to other treatments.

Participants in the study will receive the investigational medication as an intravenous (IV) infusion every 21 days. The study is divided into two parts: first, testing different doses to find a safe level, and then expanding to more participants at the chosen dose. The study will monitor participants closely to ensure their safety and to collect data on how their cancer responds to the treatment.

  • Who can participate: Adults with refractory or resistant CMML or relapsed/refractory monocytic or monocytic-predominant AML can participate. They must have an ECOG Performance Status of 2 or less and agree to use contraception during the study and for 90 days after.
  • Study details: Participants will receive the investigational medication through an IV infusion every 21 days. Their health and response to the treatment will be monitored.
Study details
    Chronic Myelomonocytic Leukemia
    Chronic Myelomonocytic Leukemia (CMML)
    Chronic Myelomonocytic Leukemia-1
    Chronic Myelomonocytic Leukemia-2
    Refractory Chronic Myelomonocytic Leukemia
    CMML
    Acute Myeloid Leukemia
    Acute Myeloid Leukemia (AML)
    Acute Myeloid Leukemia Post Cytotoxic Therapy
    Acute Myeloid Leukemias
    Refractory Acute Myeloid Leukemia (AML)
    Acute Monocytic Leukemia

NCT06950034

Solu Therapeutics, Inc

30 April 2025

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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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