Hematologic Malignancies Clinical Trial
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
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.
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 venetoclax-based regimens are being assessed in five different cohorts in the expansion Group 3. The cohorts in Group 3 include three cohorts to assess different dose levels (Cohorts 1, 2, and 3), a cohort enrolling patients with r/r AML and ASXL1 mutations and a cohort enrolling patients with r/r AML with other myelodysplasia-related mutations other than ASXL1. ;
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