NCT04588922

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Sellas Life Sciences Group · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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 (Cohort 4) and a cohort enrolling patients with r/r AML with other myelodysplasia-related mutations other than ASXL1 (Cohort 5). Group 4 (newly diagnosed AML with higher risk features by cytogenetic/morphology) and Group 5 (first-line AML patients who failed to achieve an object response after 2 cycles of azacitidine/venetoclax) have been added to evaluate efficacy, safety, and tolerability of GFH009 in combination with venetoclax and azacitidine.

Conditions

• Hematologic Malignancies

Interventions

Type	Name	Description
DRUG	SLS009	Solution for injection
DRUG	venetoclax	Tablets
DRUG	azacitidine	Solution for injection

Timeline

• Start date: 2021-05-10
• Primary completion: 2026-12-30
• Completion: 2027-12-31
• First posted: 2020-10-19
• Last updated: 2026-03-16

Locations

21 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study