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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation in the Absence of Specific Azole Antifungal Treatments | Experimental | Up to 9 dose levels will be evaluated in subjects not receiving specific azole antifungal treatment. |
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| Dose Escalation in the Presence of Specific Azole Antifungal Treatments | Experimental | Up to 9 dose levels will be evaluated in subjects receiving specific azole antifungal treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGR-2921 | Drug | SGR-2921 will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicities | 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. | Throughout the study, up to 26 months. |
| Electrocardiograms in Singlicate and Triplicate | Uncorrected QT interval, QTcF, PR duration, QRS interval, and RR interval. | Throughout the study, up to 26 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Throughout the study, up to 26 months. |
| SGR-2921 Minimum Plasma Concentration (Cmin) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Weiss, M.D. | Schrödinger, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States | ||
| The University of Kansas Clinical Research Center |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 7, 2026 | |
| Reset | Jun 2, 2026 |
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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). |
| 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). | Throughout the study, up to 26 months. |
| SGR-2921 Area Under the Concentration Versus Time Curve (AUC) | 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). | 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). | 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). | Throughout the study, up to 26 months. |
| Objective Response Rate (ORR) for Subjects with MDS | The percentage of subjects achieving CR and PR. | 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. | 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. | Throughout the study, up to 26 months. |
| Fairway |
| Kansas |
| 66205 |
| United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Wexner Medical Center - James Cancer Hospital | Columbus | Ohio | 43210 | United States |
| Oncology Associates of Oregon, P.C. | Eugene | Oregon | 97401 | United States |
| Oregon Health & Science University - Knight Cancer Institute - Center of Hematologic Malignancies | Portland | Oregon | 97239 | United States |
| Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization | Philadelphia | Pennsylvania | 19107 | United States |
| TriStar Bone Marrow Transplant, LLC | Nashville | Tennessee | 37203 | United States |
| St. David's South Austin Medical Center | Austin | Texas | 78745 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 7, 2026 | Jun 2, 2026 |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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