Study of SGR-2921 in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
NCT ID: NCT05961839
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
66 participants
INTERVENTIONAL
2023-09-27
2025-09-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation in the Absence of Specific Azole Antifungal Treatments
Up to 9 dose levels will be evaluated in subjects not receiving specific azole antifungal treatment.
SGR-2921
SGR-2921 will be administered orally.
Dose Escalation in the Presence of Specific Azole Antifungal Treatments
Up to 9 dose levels will be evaluated in subjects receiving specific azole antifungal treatment.
SGR-2921
SGR-2921 will be administered orally.
Interventions
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SGR-2921
SGR-2921 will be administered orally.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Schrödinger, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Weiss, M.D.
Role: STUDY_DIRECTOR
Schrödinger, Inc.
Locations
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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
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
St. David's South Austin Medical Center
Austin, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Other Identifiers
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SGR-2921-101
Identifier Type: -
Identifier Source: org_study_id
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