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

NCT05961839 | Terminated Phase 1 FDA Drug

• 1 other identifier: SGR-2921-101
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 12

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.

Conditions

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

Keywords

MDS; Relapsed or Refractory AML

Outcome Measures

Primary Outcomes (3)

• Dose Limiting Toxicities

  From first dose until the end of Cycle 1 (approximately 28 days, up to 42 days).

• Adverse Events

  Incidence, nature, and severity of adverse events (AEs) as assessed by the NCI CTCAE v5.0.

  Throughout the study, up to 26 months.

• Electrocardiograms in Singlicate and Triplicate

  Uncorrected QT interval, QTcF, PR duration, QRS interval, and RR interval.

  Throughout the study, up to 26 months.

Secondary Outcomes (9)

• SGR-2921 Maximal Plasma Concentration (Cmax)

  Throughout the study, up to 26 months.

• SGR-2921 Minimum Plasma Concentration (Cmin)

  Throughout the study, up to 26 months.

• SGR-2921 Time to Maximal Plasma Concentration (tmax)

  Throughout the study, up to 26 months.

• SGR-2921 Area Under the Concentration Versus Time Curve (AUC)

  Throughout the study, up to 26 months.

• Composite Complete Remission (CR) Rate for Subjects with AML

  Throughout the study, up to 26 months.

Study Arms (2)

Dose Escalation in the Absence of Specific Azole Antifungal Treatments

EXPERIMENTAL

Up to 9 dose levels will be evaluated in subjects not receiving specific azole antifungal treatment.

Drug: SGR-2921

Dose Escalation in the Presence of Specific Azole Antifungal Treatments

EXPERIMENTAL

Up to 9 dose levels will be evaluated in subjects receiving specific azole antifungal treatment.

Drug: SGR-2921

Interventions

SGR-2921 DRUG

SGR-2921 will be administered orally.

Dose Escalation in the Absence of Specific Azole Antifungal Treatments; Dose Escalation in the Presence of Specific Azole Antifungal Treatments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Schrödinger, Inc.: lead

Study Sites (12)

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

The University of Kansas Clinical Research Center

Fairway, Kansas, 66205, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center - James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

Oncology Associates of Oregon, P.C.

Eugene, Oregon, 97401, United States

Location

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

Portland, Oregon, 97239, United States

Location

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

Philadelphia, Pennsylvania, 19107, United States

Location

TriStar Bone Marrow Transplant, LLC

Nashville, Tennessee, 37203, United States

Location

St. David's South Austin Medical Center

Austin, Texas, 78745, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Recurrence

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Weiss, M.D.

  Schrödinger, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 27, 2023
• Study Start: September 27, 2023
• Primary Completion: August 14, 2025
• Study Completion: September 9, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)