Study on S227928 Alone and with Venetoclax for Patients with Certain Blood Cancers
Sponsor: Servier Bio-Innovation LLC
ClinicalTrials ID:NCT06563804
This clinical trial is testing a new drug, S227928, both by itself and combined with another drug, Venetoclax, to see if it is safe and effective for patients with certain types of blood cancers that have returned or not responded to treatment.
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Program Overview
The study aims to find out if S227928, alone or with Venetoclax, is safe and can help treat certain blood cancers like AML, MDS/AML, or CMML that have come back or are resistant to treatment. It starts with a Phase 1 part to find the best dose, then moves to Phase 2 to see how well it works. Participants will have regular check-ups every two weeks during treatment, and follow-up visits every 12 weeks for six months after treatment ends. These visits may include tests like blood and urine samples, heart monitoring, and physical exams.
Eligibility Criteria
Inclusion Criteria
- Be in good general health with an ECOG performance status of 0 to 2.
- Women who can have children must use effective birth control during the study and for six months after the last dose.
- Men with partners who can have children must use condoms during the study and for three months after the last dose.
- Have a confirmed diagnosis of AML, MDS/AML, or CMML that has returned or not responded to at least one standard treatment.
- Not be eligible for further standard therapy.
- Have a white blood cell count below 10 x 10^9/L (medication can be used to achieve this).
- Have good kidney function with a creatinine clearance of at least 60 mL/min.
- Have good liver function with specific enzyme levels within set limits.
Exclusion Criteria
- Women who are pregnant or breastfeeding.
- Positive pregnancy test for women who can have children.
- Individuals under legal guardianship.
- Not fully recovered from side effects of previous treatments.
- Have certain other blood disorders or types of leukemia.
- Have uncontrolled infections or certain viral infections like hepatitis B or C.
- Have HIV with specific conditions like low CD4 counts or high viral load.
- Have significant heart problems or conditions that affect heart rhythm.
- Have active cancer in the central nervous system.
- Have bleeding disorders or other serious medical conditions.
- Have had major surgery recently or not recovered from surgery.
- Have had a stem cell transplant within the last three months.
- Have other active cancers, with some exceptions.
- Have severe allergies to study drugs.
- Have had recent cancer treatments or certain medications that affect the heart.
- Have had cellular therapies or radiation therapy recently.
- Be taking medications that affect the study drugs' effectiveness or safety.
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