Acute Myeloid Leukemia Clinical Trial

Study of SGR-2921 in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

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.

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Full 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.

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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.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

50

Study ID:

NCT05961839

Recruitment Status:

Recruiting

Sponsor:

Schrödinger, Inc.

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There are 3 Locations for this study

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Colorado Blood Cancer Institute
Denver Colorado, 80218, United States More Info
Marcello Rotta, MD
Principal Investigator
TriStar Bone Marrow Transplant, LLC
Nashville Tennessee, 37203, United States More Info
Steven Strickland, MD
Principal Investigator
St. David's South Austin Medical Center
Austin Texas, 78745, United States More Info
Aravind Ramakrishnan, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

50

Study ID:

NCT05961839

Recruitment Status:

Recruiting

Sponsor:


Schrödinger, Inc.

How clear is this clinincal trial information?

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