RecruitingPhase 1NCT06484062

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

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)

Sponsor

National Cancer Institute (NCI)

Enrollment

54 participants

Start Date

Aug 15, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Myelodysplastic Syndrome Recurrent Myelodysplastic Syndrome Refractory Myelodysplastic Syndrome Recurrent Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia Myelodysplastic Syndrome/Acute Myeloid Leukemia Recurrent Myelodysplastic Syndrome/Acute Myeloid Leukemia Refractory Myelodysplastic Syndrome/Acute Myeloid Leukemia

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called cirtuvivint — alone and in combination with another drug (ASTX727) — in adults whose acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS, a bone marrow disorder) has come back or stopped responding to earlier treatments. **You may be eligible if...** - You are 18 or older - Your AML or MDS has relapsed or was resistant to prior treatment, including treatments with or without venetoclax - You have adequate organ function (heart, liver, kidneys) - You are generally well enough to participate (as assessed by your doctor) **You may NOT be eligible if...** - You have never been diagnosed with AML or MDS - You have active central nervous system involvement from your blood cancer - You have severe organ dysfunction - You are pregnant or planning to become pregnant - You have certain serious infections or other uncontrolled illnesses Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

DRUGCirtuvivint

Given PO

DRUGDecitabine and Cedazuridine

Given PO

PROCEDUREEchocardiography Test

Undergo ECHO

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

Locations(21)

Yale University

New Haven, Connecticut, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States

UChicago Medicine Northwest Indiana

Crown Point, Indiana, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06484062

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