Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML

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. Groups 4

Trial Details

NCT ID
NCT04588922
Phase
PHASE1 / PHASE2
Sponsor
Sellas Life Sciences Group
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • SLS009
  • venetoclax
  • azacitidine
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Goodyear, Arizona, United States|33.43532,-112.35821
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Scottsdale, Arizona, United States|33.50921,-111.89903
  • Duarte, California, United States|34.13945,-117.97729

Key Eligibility Criteria

  • For Groups 1, 2, 3, 4 and 5:
  • Patients eligible for inclusion must meet all of the following criteria:
  • Male or female ≥ 18 years. For Group 3 Cohorts 4 and 5 only male or female ≥18 years and pediatric patients 12-18 years and ≥40 kg body mass
  • Written informed consent must be obtained prior to any screening procedures

For full eligibility, visit ClinicalTrials.gov.

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