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.
Additional locations may be listed on ClinicalTrials.gov for NCT05961839.
See trial information on ClinicalTrials.gov for a list of participating sites.
This is a study of SGR-2921, an oral, small molecule inhibitor of cell division cycle
7-related protein kinase (CDC7), in subjects with Relapsed/Refractory (R/R) Acute Myeloid
Leukemia (AML) or Myelodysplastic Syndrome (MDS) to evaluate the safety, pharmacokinetics
(PK), pharmacodynamics (PD), maximum tolerated dose (MTD) and/or recommended dose (RD) of
SGR-2921.
Exploratory cohorts may evaluate additional PK, PD, preliminary anti-tumor activity, and
safety to establish the SGR-2921 RD. A planned amendment will evaluate SGR-2921 in
combination with other approved AML/MDS treatments such as hypomethylating agents (HMA),
BCL2 inhibitors, IDH inhibitors or FLT3 inhibitors, in patients with AML and/or MDS.
Lead OrganizationSchrödinger, Inc.
Principal InvestigatorDaniel Weiss