Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies

Description

SLS009 (formerly GFH009) is a potent and highly selective CDK9 inhibitor. In this study the safety, tolerability, and antitumor activity of single agent SLS009 are assessed in two dose escalation groups (Group 1 in patients with relapsed/refractory AML, Group 2 in patients with relapse/refractory lymphoma/CLL/SLL). The safety, tolerability, and antitumor activity of SLS009 in combination with venetoclax and azacitidine in patient with relapsed/refractory AML who have relapsed on or are refractory to venetoclax-based regimens are being assessed in five cohorts of the expansion Group 3.

Conditions

Hematologic Malignancies

Study Overview

Study Details

Study overview

SLS009 (formerly GFH009) is a potent and highly selective CDK9 inhibitor. In this study the safety, tolerability, and antitumor activity of single agent SLS009 are assessed in two dose escalation groups (Group 1 in patients with relapsed/refractory AML, Group 2 in patients with relapse/refractory lymphoma/CLL/SLL). The safety, tolerability, and antitumor activity of SLS009 in combination with venetoclax and azacitidine in patient with relapsed/refractory AML who have relapsed on or are refractory to venetoclax-based regimens are being assessed in five cohorts of the expansion Group 3.

A Phase I/IIa, Open-Label Dose Escalation and Dose Expansion Study of Intravenous GFH009 Single Agent and in Combination With Venetoclax and Azacitidine in Patients With Relapsed/Refractory Hematologic Malignancies

Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies

Condition
Hematologic Malignancies
Intervention / Treatment

-

Contacts and Locations

Birmingham

O'Neal Comprehensive Cancer Center, University of Alabama, Birmingham, Alabama, United States, 35233

New Orleans

Ochsner Clinic Foundation, New Orleans, Louisiana, United States, 70121

Lake Success

Clinical Research Alliance, Inc., Lake Success, New York, United States, 11042

New York

New York - Presbyterian Hospital, New York, New York, United States, 10032

Chapel Hill

UNC School of Medicine, Division of Hematology, Chapel Hill, North Carolina, United States, 27599

Greenville

Bon Secours St. Francis Cancer Center, Greenville, South Carolina, United States, 29607

Dallas

Baylor Scott & White Health, Dallas, Texas, United States, 75246

Houston

MD Anderson, Houston, Texas, United States, 77091

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

    Ages Eligible for Study

    12 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Sellas Life Sciences Group,

    Dragan Cicic, MD, STUDY_CHAIR, SELLAS Life Sciences Group, Inc.

    Study Record Dates

    2025-12-31