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Evaluating SGR-2921 for patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome

A First-In-Human, Phase 1, Dose Escalation Study of SGR-2921 as Monotherapy In Subjects With Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Phase 1 Interventional Schrödinger, Inc. · NCT05961839

This study is testing a new oral medication called SGR-2921 to see if it is safe and effective for people with relapsed or hard-to-treat acute myeloid leukemia or myelodysplastic syndrome.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment50 (estimated)
Ages18 Years and up
SexAll
SponsorSchrödinger, Inc. Industry-sponsored
Locations12 sites (Denver, Colorado and 11 other locations)
Trial IDNCT05961839 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of SGR-2921, an oral small molecule inhibitor targeting CDC7, in patients with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). The study aims to determine the maximum tolerated dose (MTD) and/or recommended dose (RD) of SGR-2921 while also exploring its pharmacokinetics and pharmacodynamics. Additionally, exploratory cohorts may assess the drug's preliminary anti-tumor activity and safety, particularly in combination with other approved treatments for AML and MDS.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of relapsed or refractory AML or high-risk MDS.

Not a fit: Patients with active malignancies unrelated to AML or MDS, or those with severe cardiac issues, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat forms of AML and MDS.

How similar studies have performed: While this approach is novel, similar studies targeting cell division pathways have shown promise in other hematological malignancies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* ≥ 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.

Exclusion Criteria:

* 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 this trial is running

Denver, Colorado and 11 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Myeloid LeukemiaHigh-Risk and Very High-Risk Myelodysplastic SyndromesMDSRelapsed or Refractory AML
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.