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NCT05961839 | RECRUITING | Acute Myeloid Leukemia

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

Schrödinger, Inc.

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.

Condition or disease

Acute Myeloid Leukemia

High-Risk and Very High-Risk Myelodysplastic Syndromes

Intervention/treatment

SGR-2921

Phase

PHASE1

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-09-27
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 of SGR-2921 in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Location Details

NCT05961839

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

Colorado Blood Cancer Institute

Denver, Colorado, United States, 80218

RECRUITING

United States, Kansas

The University of Kansas Clinical Research Center

Fairway, Kansas, United States, 66205

RECRUITING

United States, New York

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, Ohio

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

RECRUITING

United States, Ohio

The Ohio State University Wexner Medical Center - James Cancer Hospital

Columbus, Ohio, United States, 43210

RECRUITING

United States, Oregon

Oncology Associates of Oregon, P.C.

Eugene, Oregon, United States, 97401

RECRUITING

United States, Oregon

Oregon Health & Science University - Knight Cancer Institute - Center of Hematologic Malignancies

Portland, Oregon, United States, 97239

RECRUITING

United States, Pennsylvania

Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization

Philadelphia, Pennsylvania, United States, 19107

RECRUITING

United States, Tennessee

TriStar Bone Marrow Transplant, LLC

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

St. David's South Austin Medical Center

Austin, Texas, United States, 78745

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030