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Clinical trial intelligence report
A Phase I Study Evaluating the Safety of Cirtuvivint as Monotherapy and in Combination With ASTX727 in Patients With Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jul 28, 2026
Report code
NCT06484062-Jul 28, 2026
NCT ID
NCT06484062
Status
RECRUITING
Phase
Phase 1
Sponsor
National Cancer Institute (NCI)
Executive brief
Investment-Ready Snapshot
The ongoing Phase I trial sponsored by the National Cancer Institute (NCI) evaluates the safety and efficacy of cirtuvivint as a monotherapy and in combination with ASTX727 for treating relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Given the high unmet medical need in these indications, successful outcomes could position cirtuvivint as a competitive option in a market with limited effective therapies. The trial's focus on both monotherapy and combination therapy may enhance its commercial viability, particularly if it demonstrates improved safety and efficacy profiles compared to existing treatments. Stakeholders should monitor enrollment and preliminary efficacy data closely, as these will inform future development strategies and potential partnerships.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT06484062
Indication
Acute Myeloid Leukemia
Modality
small molecule
Target
Cirtuvivint (SM08502) targets CLK and DYRK kinases, potentially inhibiting cancer cell growth by blocking enzymes necessary for cell proliferation. ASTX727 combines decitabine, a hypomethylating agent, and cedazuridine, a cytidine deaminase inhibitor, enhancing the efficacy of decitabine by preventing its breakdown.
Intervention
Biospecimen Collection, Bone Marrow Aspiration, Cirtuvivint, Decitabine and Cedazuridine, Echocardiography Test, Multigated Acquisition Scan
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.