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Study description
The study is needed to test a drug called S65487 in combination with an approved treatment called azacitidine in patients with a type of blood cancer called acute myeloid leukemia (AML).
AML is a cancer of the blood and bone marrow (the spongy tissue inside bones where blood cells are made). In AML, cancer cells have higher amounts of certain proteins. One of these proteins is BCL-2 (B-cell lymphoma-2). This protein protects cancer cells from death, allowing them to survive and multiply.
The main goals of this study are:
- To test how safe S65487 is when combined with azacitidine.
- To find the dose of S65487 with azacitidine that is both safe and effective (the recommended dose) for patients with AML.
- To see how well S65487 works when combined with azacitidine in patients with AML.
- S65487 and azacitidine
- CL1-65487-003
Eligibility Criteria
Eligible age for the study
Sexes
Male/FemaleAccepts Healthy Volunteers
NoTo take part in the study, participants have to:
- Be at least 18 years old.
- Have confirmed AML that has not been treated before.
- Have adequate kidney, liver, and heart function.
Participants cannot take part in the study if they:
- Had radiation therapy or major surgery within 3 weeks before starting the study.
- Have previously received a drug that blocks BCL-2.
How is the study designed?
Participants receive both S65487 and azacitidine over a period of 4 weeks. S65487 is given through an intravenous (IV), which means it will be injected directly into a vein. Azacitidine can be given either through an injection under the skin (subcutaneous) or through an IV.