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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Bone Marrow Aspiration — PROCEDURE
  Undergo bone marrow aspiration
• Cirtuvivint — DRUG
  Given PO
• Decitabine and Cedazuridine — DRUG
  Given PO
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• Multigated Acquisition Scan — PROCEDURE
  Undergo MUGA

Study Details

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.

Key Dates

Start date

Aug 15, 2025

Status verified

Apr 2026

Primary completion

Jun 1, 2028

Completion

Jun 1, 2028

Study Design

Enrollment

54 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort I (cirtuvivint)
  Patients receive cirtuvivint PO QD on days 1-5, 8-12, 15-19, and 22-26 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA at screening. In addition, patients undergo blood sample collection and bone marrow aspiration at screening and on study.
• Experimental: Cohort II (cirtuvivint)
  Patients receive cirtuvivint PO QD on days 1, 4, 8, 11, 15, 18, 22, and 25 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA at screening. In addition, patients undergo blood sample collection and bone marrow aspiration at screening and on study.
• Experimental: Cohort III (cirtuvivint, ASTX727)
  Patients receive cirtuvivint PO QD on days 1, 4, 8, 11, 15, 18, 22, and 25 and ASTX727 PO QD on days 1-5 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA at screening. In addition, patients undergo blood sample collection and bone marrow aspiration at screening and on study.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: Up to day 28 ]

Locations (22)

Find similar trials in New Haven, CT

Related Studies

• Collection of Tissue Samples for Cancer Research
  Recruiting · National Cancer Institute (NCI) · Sacramento, California
• Monitoring Minimal Residual Disease of Patients With Acute Myelogenous Leukemia or High Grade Myelodysplastic Syndrome
  Recruiting · University of Rochester · Rochester, New York
• KIR Favorable Mismatched Haplo Transplant and KIR Polymorphism in ALL/AML/MDS Allo-HCT Children
  PHASE2 · Enrolling By Invitation · Michael Pulsipher · Los Angeles, California
• SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
  PHASE1 · Recruiting · Dana-Farber Cancer Institute · Duarte, California