Study of SGR-2921 in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Stopped early · Phase 1

Conditions studied: Acute Myeloid Leukemia, High-Risk and Very High-Risk Myelodysplastic Syndromes

In brief

The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) and/or recommended dose (RD) of SGR-2921.

Key facts

Study ID

NCT05961839

Run by

Schrödinger, Inc.

People needed

66

Starts

2023-09-27

Expected to finish

2025-09-09

Last updated by the study team

2025-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years of age.
• Life expectancy ≥ 8 weeks.
• Confirmed diagnosis of R/R AML or High Risk (HR) and Very High Risk (VHR) MDS.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

You may not qualify if…

• Active malignancies within two years prior to the first dose, or requiring ongoing treatment, not related to AML or MDS.
• Clinical evidence of central nervous system (CNS) or pulmonary leukostasis, ≥ Grade 3 disseminated intravascular coagulation, or active CNS leukemia.
• Use of experimental drug, or therapy, or anti-cancer therapy within 14 days or 5 half-lives of the first dose of study drug.
• QT interval corrected for heart rate per Fridericia's formula ≥470 msec during screening ECG.

Where it is running

• Colorado Blood Cancer Institute — Denver, Colorado, United States
• The University of Kansas Clinical Research Center — Fairway, Kansas, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• The Ohio State University Wexner Medical Center - James Cancer Hospital — Columbus, Ohio, United States
• Oncology Associates of Oregon, P.C. — Eugene, Oregon, United States
• Oregon Health & Science University - Knight Cancer Institute - Center of Hematologic Malignancies — Portland, Oregon, United States
• Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization — Philadelphia, Pennsylvania, United States
• TriStar Bone Marrow Transplant, LLC — Nashville, Tennessee, United States
• St. David's South Austin Medical Center — Austin, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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