Trial Title:
Study of SGR-2921 in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
NCT ID:
NCT05961839
Condition:
Acute Myeloid Leukemia
High-Risk and Very High-Risk Myelodysplastic Syndromes
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Syndrome
Conditions: Keywords:
MDS
Relapsed or Refractory AML
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SGR-2921
Description:
SGR-2921 will be administered orally.
Arm group label:
Dose Escalation in the Absence of Specific Azole Antifungal Treatments
Arm group label:
Dose Escalation in the Presence of Specific Azole Antifungal Treatments
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.
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Colorado Blood Cancer Institute
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Marcello Rotta, MD
Email:
Principal Investigator
Facility:
Name:
The University of Kansas Clinical Research Center
Address:
City:
Fairway
Zip:
66205
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Jesus Gonzalez Lugo, MD
Email:
Principal Investigator
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Eunice Wang, MD
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Eytan Stein, MD
Email:
Principal Investigator
Facility:
Name:
Cleveland Clinic Foundation
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Hetty Carraway, MD
Email:
Principal Investigator
Facility:
Name:
The Ohio State University Wexner Medical Center - James Cancer Hospital
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Alice Mims, MD
Email:
Principal Investigator
Facility:
Name:
Oncology Associates of Oregon, P.C.
Address:
City:
Eugene
Zip:
97401
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Luke Fletcher, MD
Email:
Principal Investigator
Facility:
Name:
Oregon Health & Science University - Knight Cancer Institute - Center of Hematologic Malignancies
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Elie Traer, MD
Email:
Principal Investigator
Facility:
Name:
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Gina Keiffer, MD
Email:
Principal Investigator
Facility:
Name:
TriStar Bone Marrow Transplant, LLC
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Steven Strickland, MD
Email:
Principal Investigator
Facility:
Name:
St. David's South Austin Medical Center
Address:
City:
Austin
Zip:
78745
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Aravind Ramakrishnan, MD
Email:
Principal Investigator
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Courtney DiNardo, MD
Email:
Principal Investigator
Start date:
September 27, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Schrödinger, Inc.
Agency class:
Industry
Source:
Schrödinger, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05961839
