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

Description

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.

Conditions

Acute Myeloid Leukemia, High-Risk and Very High-Risk Myelodysplastic Syndromes

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Study Overview

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Study Details

Study overview

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.

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

Condition
Acute Myeloid Leukemia
Intervention / Treatment

-

Contacts and Locations

Denver

Colorado Blood Cancer Institute, Denver, Colorado, United States, 80218

Fairway

The University of Kansas Clinical Research Center, Fairway, Kansas, United States, 66205

Buffalo

Roswell Park Cancer Institute, Buffalo, New York, United States, 14263

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Cleveland

Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Columbus

The Ohio State University Wexner Medical Center - James Cancer Hospital, Columbus, Ohio, United States, 43210

Eugene

Oncology Associates of Oregon, P.C., Eugene, Oregon, United States, 97401

Portland

Oregon Health & Science University - Knight Cancer Institute - Center of Hematologic Malignancies, Portland, Oregon, United States, 97239

Philadelphia

Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization, Philadelphia, Pennsylvania, United States, 19107

Nashville

TriStar Bone Marrow Transplant, LLC, Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Schrödinger, Inc.,

Daniel Weiss, M.D., STUDY_DIRECTOR, Schrödinger, Inc.

Study Record Dates

2025-12