Go back to trials list
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
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.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.
Trial Eligibility
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 Info
Organization
Schrödinger, Inc.
Primary Outcome
Dose Limiting Toxicities
Interventions
Locations Recruiting
Colorado Blood Cancer Institute
United States, Colorado, Denver
The University of Kansas Clinical Research Center
United States, Kansas, Fairway
Roswell Park Cancer Institute
United States, New York, Buffalo
Memorial Sloan Kettering Cancer Center
United States, New York, New York
Cleveland Clinic Foundation
United States, Ohio, Cleveland
Interested in joining this trial?
Our dedicated patient navigators are here to guide you through the validation and enrollment process with ease.
![newsletter icon](https://static.healthtree.org/icons/newsletter-icon.png)
Get the latest thought leadership on your Polycythemia Vera delivered straight to your inbox
Subscribe to the weekly newsletter for news, stories, clinical trial updates, and helpful resources and events with cancer experts.