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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
SGR-2921 will be administered orally.
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
Dose Limiting Toxicities
Time frame: From first dose until the end of Cycle 1 (approximately 28 days, up to 42 days).
Adverse Events
Incidence, nature, and severity of adverse events (AEs) as assessed by the NCI CTCAE v5.0.
Time frame: Throughout the study, up to 26 months.
Electrocardiograms in Singlicate and Triplicate
Uncorrected QT interval, QTcF, PR duration, QRS interval, and RR interval.
Time frame: Throughout the study, up to 26 months.
SGR-2921 Maximal Plasma Concentration (Cmax)
Concentrations of SGR-2921 in plasma are measured at various timepoints following its administration to calculate typical exposure/PK parameters, including, but not limited to, the maximal plasma concentration (Cmax).
Time frame: Throughout the study, up to 26 months.
SGR-2921 Minimum Plasma Concentration (Cmin)
Concentrations of SGR-2921 in plasma are measured at various timepoints following its administration to calculate typical exposure/PK parameters, including, but not limited to, the minimum plasma concentration (Cmin).
Time frame: Throughout the study, up to 26 months.
SGR-2921 Time to Maximal Plasma Concentration (tmax)
Concentrations of SGR-2921 in plasma are measured at various timepoints following its administration to calculate typical exposure/PK parameters, including, but not limited to, the time to maximal plasma concentration (tmax).
Time frame: Throughout the study, up to 26 months.
SGR-2921 Area Under the Concentration Versus Time Curve (AUC)
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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
...and 2 more locations
Concentrations of SGR-2921 in plasma are measured at various timepoints following its administration to calculate typical exposure/PK parameters, including, but not limited to, the area under the concentration versus time curve (AUC).
Time frame: Throughout the study, up to 26 months.
Composite Complete Remission (CR) Rate for Subjects with AML
The percentage of subjects with CR, CR with Partial Hematologic Recovery (CRh), and CR with Incomplete Blood Count Recovery (CRi).
Time frame: Throughout the study, up to 26 months.
Objective Response Rate (ORR) for Subjects with AML
The percentage of subjects achieving CR, CRh, CRi, morphologic leukemia-free state (MLFS) and Partial Response (PR).
Time frame: Throughout the study, up to 26 months.
Objective Response Rate (ORR) for Subjects with MDS
The percentage of subjects achieving CR and PR.
Time frame: Throughout the study, up to 26 months.
Duration of Response (DOR) for Subjects with AML
The time from first response (CR, CRh, CRi, MLFS, or PR) to the date of initial objectively documented progression or death due to any cause, whichever occurs first.
Time frame: Throughout the study, up to 26 months.
Duration of Response (DOR) for subjects with MDS
The time from first response (CR or PR) to the date of initial objectively documented progression or death due to any cause, whichever occurs first.
Time frame: Throughout the study, up to 26 months.