A Study to Evaluate S227928 as a Single Agent and in Combination With Venetoclax in Patients With… (NCT06563804) | Clinical Trial Compass
TerminatedPhase 1/2
A Study to Evaluate S227928 as a Single Agent and in Combination With Venetoclax in Patients With R/R AML, MDS/AML, or CMML
Stopped: Sponsor decision
United States13 participantsStarted 2025-02-25
Plain-language summary
The objective of this study is to determine the safety, tolerability, and anti-leukemic activity of S227928 as single agent and in combination with venetoclax, and to determine the recommended Phase 2 dose (RP2D) of this combination. The study will begin as a Phase 1 Dose Escalation study to determine the RP2D and then will transition to a Phase 2 Dose Expansion study to assess the efficacy of the selected RP2D. During the treatment period participants will have study visits every two weeks, with additional visits occurring during the first and second cycle. Approximately 30 days after treatment has ended, an end-of-treatment visit will occur and then participants will be followed for survival every 12 weeks for the next 6 months. Study visits may include a bone marrow aspirate and/or biopsy, blood and urine tests, ECG, vital signs, physical examination, and administration of study treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients must not be candidates for further standard therapy,
✓. Treatment with agents for lower risk MDS such as erythropoietin or luspatercept are not considered anticancer therapies.
✓. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN),
✓. Total bilirubin level ≤ 1.5 x ULN, except for patients with known Gilbert's syndrome, who may be included if their total bilirubin is ≤ 3.0 x ULN and their direct bilirubin is ≤ 1.5 x ULN.
Exclusion criteria
✕. CD4+ T-cell (CD4+) counts \< 350 cells/µL
✕. Acquired immunodeficiency syndrome-defining opportunistic infection within 12 months prior to screening
✕. Not on antiretroviral therapy, or on antiretroviral therapy for \< 6 weeks at the time of Day 1 in Cycle 1
✕. HIV viral load ≥ 400 copies/mL
✕. Uncontrolled arterial hypertension per the investigator's judgment
What they're measuring
1
Dose Escalation: Number and severity of Dose Limiting Toxicities (DLTs)
Timeframe: Through Cycle 1 (each cycle is 28 days)
2
Dose Escalation: Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Through 30 days after the end of treatment (Approximately 3.5 years)
3
Dose Escalation: Number of dose reductions, interruptions, delays, or study withdrawal due to AEs
Timeframe: Through 30 days after the end of treatment (Approximately 3.5 years)
4
Dose Expansion: Complete remission (CR)
Timeframe: Through 6 months after the end of treatment (Approximately 4 years)
✕. New York Heart Association class III or IV congestive heart failure
✕. Congenital or substance-induced long QT defined as heart rate-corrected QT (QTc) interval \>450 ms for males and \>470 ms for females according to Fridericia's formula
✕. Uncontrolled cardiac arrhythmia (e.g., participants with rate-controlled atrial fibrillation are eligible)