RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-05-10
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04588922

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.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

James Dean
CONTACT
+1 609-900-5080
jdean@sellaslife.com
Clinical Trials Info at Sellas
CONTACT
+1 646-200-5278
clinicaltrialinfo@sellaslife.com

Principal Investigator

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

Study Locations (Sites)

O'Neal Comprehensive Cancer Center, University of Alabama
Birmingham, Alabama, 35233
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
United States
Clinical Research Alliance, Inc.
Lake Success, New York, 11042
United States
New York - Presbyterian Hospital
New York, New York, 10032
United States
UNC School of Medicine, Division of Hematology
Chapel Hill, North Carolina, 27599
United States
Bon Secours St. Francis Cancer Center
Greenville, South Carolina, 29607
United States
Baylor Scott & White Health
Dallas, Texas, 75246
United States
MD Anderson
Houston, Texas, 77091
United States

Collaborators and Investigators

Sponsor: Sellas Life Sciences Group

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-10
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-05-10
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Acute Myeloid Leukemia,
  • AML
  • Lymphoma
  • Chronic Lymphocytic Lymphoma
  • CLL
  • Small Lymphocytic Lymphoma
  • SLL
  • relapsed
  • refractory
  • CDK9 inhibitor
  • GFH009
  • SLS009
  • venetoclax
  • azacitidine
  • ASXL1

Additional Relevant MeSH Terms

  • Hematologic Malignancies