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 early · Phase 1/Phase 2
Conditions studied: Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)/AML, Chronic Myelomonocytic Leukemia (CMML)
In brief
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.
Key facts
- Study ID
- NCT06563804
- Run by
- Servier Bio-Innovation LLC
- People needed
- 13
- Starts
- 2025-02-25
- Expected to finish
- 2025-10-09
- Last updated by the study team
- 2026-03-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- City of Hope — Duarte, California, United States
- The University of Kansas — Fairway, Kansas, United States
- START Midwest — Grand Rapids, Michigan, United States
- Memorial Sloan Kettering — New York, New York, United States
- Fred Hutch Cancer Center — Seattle, Washington, United States
- Peter MacCallum Cancer Centre — Melbourne, Australia
- Prince of Wales Hospital — Randwick, Australia
- Helsinki University Hospital - Comprehensive Cancer Center — Helsinki, Finland
- Institut Paoli Calmette — Marseille, France
- Chu de Nice - Hôpital L'archet 1 — Nice, France
- CHU de Bordeaux - Hopital du Haut Levêque — Pessac, France
- Institut Gustave Roussy — Villejuif, France
- Klinikum rechts der Isar der TU München — München, Germany
- Universitätsklinikum Ulm — Ulm, Germany
- Sapporo Hokuyu Hospital — Hokkaido, Japan
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital — Tokyo, Japan
Full record on ClinicalTrials.gov
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