Back to resultsStudy of SGR-2921 in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Primary Purpose
Acute Myeloid Leukemia, High-Risk and Very High-Risk Myelodysplastic Syndromes
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SGR-2921
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring MDS, Relapsed or Refractory AML
Eligibility 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.
Sites / Locations
- TriStar Bone Marrow Transplant, LLCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dose Escalation in the Absence of Specific Azole Antifungal Treatments
Dose Escalation in the Presence of Specific Azole Antifungal Treatments
Arm Description
Up to 9 dose levels will be evaluated in subjects not receiving specific azole antifungal treatment.
Up to 9 dose levels will be evaluated in subjects receiving specific azole antifungal treatment.
Outcomes
Primary Outcome Measures
Dose Limiting Toxicities
Adverse Events
Incidence, nature, and severity of adverse events (AEs) as assessed by the NCI CTCAE v5.0.
Electrocardiograms in Singlicate and Triplicate
Uncorrected QT interval, QTcF, PR duration, QRS interval, and RR interval.
Secondary Outcome Measures
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).
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).
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).
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).
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).
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).
Objective Response Rate (ORR) for Subjects with MDS
The percentage of subjects achieving CR and PR.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05961839
Brief Title
Study of SGR-2921 in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Schrödinger, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, High-Risk and Very High-Risk Myelodysplastic Syndromes
Keywords
MDS, Relapsed or Refractory AML
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose Escalation in the Absence of Specific Azole Antifungal Treatments
Arm Type
Experimental
Arm Description
Up to 9 dose levels will be evaluated in subjects not receiving specific azole antifungal treatment.
Arm Title
Dose Escalation in the Presence of Specific Azole Antifungal Treatments
Arm Type
Experimental
Arm Description
Up to 9 dose levels will be evaluated in subjects receiving specific azole antifungal treatment.
Intervention Type
Drug
Intervention Name(s)
SGR-2921
Intervention Description
SGR-2921 will be administered orally.
Primary Outcome Measure Information:
Title
Dose Limiting Toxicities
Time Frame
From first dose until the end of Cycle 1 (approximately 28 days, up to 42 days).
Title
Adverse Events
Description
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.
Title
Electrocardiograms in Singlicate and Triplicate
Description
Uncorrected QT interval, QTcF, PR duration, QRS interval, and RR interval.
Time Frame
Throughout the study, up to 26 months.
Secondary Outcome Measure Information:
Title
SGR-2921 Maximal Plasma Concentration (Cmax)
Description
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.
Title
SGR-2921 Minimum Plasma Concentration (Cmin)
Description
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.
Title
SGR-2921 Time to Maximal Plasma Concentration (tmax)
Description
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.
Title
SGR-2921 Area Under the Concentration Versus Time Curve (AUC)
Description
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.
Title
Composite Complete Remission (CR) Rate for Subjects with AML
Description
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.
Title
Objective Response Rate (ORR) for Subjects with AML
Description
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.
Title
Objective Response Rate (ORR) for Subjects with MDS
Description
The percentage of subjects achieving CR and PR.
Time Frame
Throughout the study, up to 26 months.
Title
Duration of Response (DOR) for Subjects with AML
Description
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.
Title
Duration of Response (DOR) for subjects with MDS
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Physician
Phone
+15032991150
Email
sdgr-trials-group@schrodinger.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Weiss, M.D.
Organizational Affiliation
Schrödinger, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
TriStar Bone Marrow Transplant, LLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Strickland, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of SGR-2921 in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
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