Clinical trialNCT06484062RecruitingPhase 1Interventional

Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes

SponsorNational Cancer Institute (NCI)Enrollment54Acute Myeloid LeukemiaMyelodysplastic SyndromeMyelodysplastic Syndrome/Acute Myeloid LeukemiaRecurrent Acute Myeloid LeukemiaRecurrent Myelodysplastic SyndromeRecurrent Myelodysplastic Syndrome/Acute Myeloid Leukemia+3 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase I trial tests the safety, side effects, and best dose of SM08502 (cirtuvivint) alone and in combination with ASTX727 in treating patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Cirtuvivint may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ASTX727 is a combination of two drugs, decitabine and cedazuridine. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Giving cirtuvivint alone or in combination with ASTX727 may be safe, tolerable, and/or effective in treating patients with AML and MDS.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Evan C Chen
Dana-Farber - Harvard Cancer Center LAO
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

22 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Yale University
New Haven, Connecticut, United States
Maximilian Stahl
Recruiting
Emory University Hospital/winship Cancer Institute
Atlanta, Georgia, United States
Michael J. Hochman
Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Olatoyosi M. Odenike
Recruiting
Uc Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States
Suspended
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States
Suspended
Uchicago Medicine Northwest Indiana
Crown Point, Indiana, United States
Suspended
University of Maryland/greenebaum Cancer Center
Baltimore, Maryland, United States
Vu H. Duong
Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Evan C. Chen
Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States
Meagan Jacoby
Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States
Meagan Jacoby
Recruiting
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States
Meagan Jacoby
Recruiting
Siteman Cancer Center-South County
St Louis, Missouri, United States
Meagan Jacoby
Recruiting
Washington University School of Medicine
St Louis, Missouri, United States
Meagan Jacoby
Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Tamanna Haque
Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Tamanna Haque
Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Tamanna Haque
Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Neil D. Palmisiano
Recruiting
Memorial Sloan Kettering Commack
Commack, New York, United States
Tamanna Haque
Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Tamanna Haque
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Tamanna Haque
Recruiting
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
Tamanna Haque
Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Madelyn Burkart
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

CirtuvivintDecitabine and Cedazuridine

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 15 Aug 2025
Primary completion: 1 Jun 2028
Completion: 1 Jun 2028
Last update posted: 11 Jun 2026
Registered enrollment: 54
Registry id: NCT06484062

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.