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 and High-Risk Newly Diagnosed AML
Sellas Life Sciences Group
Summary
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 and 5 have been added to evaluate efficacy, safety, and tolerability of GFH009 in combination with venetoclax and azacitidine in newly diagnosed AML patients who are less likely to benefit from standard induction treatment with venetoclax plus HMA only regimens.
Description
SLS009 is a potent and highly selective CDK9 inhibitor. This study is investigating the safety, tolerability, and antitumor activity of SLS009 in patients with hematologic malignancies in three groups (two dose escalation groups and one expansion group). The safety and efficacy of SLS009 as a single agent are assessed in Group 1 (patients with relapsed/refractory AML) and Group 2 (patients with relapsed/refractory lymphoma/CLL/SLL). The safety and efficacy of SLS009 in combination with venetoclax and azacitidine in patients with relapsed/refractory AML who have relapsed on or are refractory to…
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria For Groups 1, 2, 3, 4 and 5: Patients eligible for inclusion must meet all of the following criteria: 1. 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 2. Written informed consent must be obtained prior to any screening procedures 3. For AML, acute promyelocytic leukemia (APL) patients are not included in the study. 4. Adequate hepatic function as evidenced by meeting all the following requirements: * Total bilirubin ≤ 1.5 × upper limit of normal (ULN) except for patients wit…
Interventions
- DrugSLS009
Solution for injection
- Drugvenetoclax
Tablets
- Drugazacitidine
Solution for injection
Locations (25)
- O'Neal Comprehensive Cancer Center, University of AlabamaBirmingham, Alabama
- City of Hope - PhoenixGoodyear, Arizona
- City of Hope National Medical CenterDuarte, California
- City of Hope - AtlantaNewnan, Georgia
- City of Hope - ChicagoZion, Illinois
- Ochsner Clinic FoundationNew Orleans, Louisiana