In short
Clinical trials are investigating S227928 in people with hard-to-treat blood cancers. The studies look at safety, tolerability, dose finding, and early signs of benefit, both alone and with venetoclax. The main groups include patients with relapsed or refractory AML, MDS/AML, and CMML.
Key points
- S227928 is being studied in a completed Phase 1/2 clinical trial in people with relapsed or refractory blood cancers. The main conditions are AML, MDS/AML, and CMML. Researchers tested S227928 alone and with venetoclax to learn about safety, tolerability, and the best dose. The Phase 1 part focused on side effects and dose-limiting toxicities. The Phase 2 part looked at anti-leukemia activity, including complete remission. The study enrolled 123 participants.
Trial overview
The clinical trial NCT06563804 studied S227928 in people with relapsed or refractory blood cancers. It was a Phase 1/2 interventional study, which means the treatment was given to participants and then checked for safety and early signs of benefit. The trial was completed and enrolled 123 participants.
Who was studied
The study focused on patients with relapsed/refractory acute myeloid leukemia (AML), myelodysplastic syndrome/AML (MDS/AML), or chronic myelomonocytic leukemia (CMML). Relapsed means the disease came back after treatment, and refractory means it did not respond well to earlier treatment. The Phase 2 part was split into two groups: cohort 1 for R/R AML or MDS/AML, and cohort 2 for R/R CMML.
What the study measured
In Phase 1, the main goals were to assess safety and tolerability, and to find the maximum tolerated dose, if appropriate. The study also measured dose-limiting toxicities (DLTs), which are side effects serious enough to limit treatment. Other Phase 1 measures included adverse events, serious adverse events, changes in vital signs, physical examination findings, laboratory tests, cardiac markers, ECG, echocardiogram with or without GLS or MUGA, and cardiac MRI. The study also tracked dose reductions, interruptions, delays, or withdrawal because of adverse events.
In Phase 2, the main outcome was complete remission (CR). This means the researchers wanted to see whether the treatment could remove clear signs of disease based on the study rules. The brief summary also says Phase 2 was designed to assess anti-leukemic activity in the two patient cohorts.
Study design and treatment groups
The study tested S227928 as a single agent and also in combination with venetoclax. In simple terms, single agent means the drug was studied by itself, while combination means it was studied together with another treatment. The intervention list also included supportive medicines and infusion-related products used in the study setting, such as venetoclax tablets, Zyloric, and Fasturtec.
Results notes from the trial record
The trial record provided here describes the study design, target diseases, and main outcome measures, but it does not give detailed final efficacy results. Because the study is marked completed, the record shows that the planned testing phase has ended, but the source data here do not include a full outcome report.