Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies
- Conditions
- Hematologic Malignancies
- Interventions
- Registration Number
- NCT04588922
- Lead Sponsor
- Sellas Life Sciences Group
- Brief 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.
- 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 and a cohort enrolling patients with r/r AML with other myelodysplasia-related mutations other than ASXL1.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Group 2. Dose escalation in patients with r/r CLL/SLL or lymphoma SLS009 In the dose escalation part, the dose levels will be escalated following the Bayesian optimal interval (BOIN) design. China and US study sites. (Completed). Group 3 Cohort 3. 30 mg BIW in patients with r/r AML. SLS009 SLS009 (30 mg BIW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed on or are refractory to venetoclax-based regimens. US study sites only. (Cohort completed). Group 1. Dose escalation in patients with r/r AML SLS009 In the dose escalation part, the dose levels will be escalated following the Bayesian optimal interval (BOIN) design. China study sites only. (Completed). Group 3 Cohort 1. 45 mg QW in patients with r/r AML SLS009 SLS009 (45 mg QW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed on or are refractory to venetoclax-based regimens. US study sites only. (Cohort completed) Group 3 Cohort 2. 60 mg QW in patients with r/r AML. SLS009 SLS009 (60 mg QW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed on or are refractory to venetoclax-based regimens. US study sites only. (Cohort completed). Group 3 Cohort 4. 30 mg BIW in patients with r/r AML with ASXL1 mutation. SLS009 SLS009 (30 mg BIW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed or are refractory to venetoclax-based regimens and with documented ASXL1 mutation. Group 3 Cohort 5. 30 mg BIW in pts with r/rAML with other than ASXL1 mutations SLS009 SLS009 (30 mg BIW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed or are refractory to venetoclax-based regimens and with documented Defining somatic mutations, Cytogenetic abnormalities defining acute myeloid leukemia, myelodysplasia related, other than ASXL1 mutation per WHO 5th Edition classification. Group 3 Cohort 2. 60 mg QW in patients with r/r AML. venetoclax SLS009 (60 mg QW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed on or are refractory to venetoclax-based regimens. US study sites only. (Cohort completed). Group 3 Cohort 1. 45 mg QW in patients with r/r AML venetoclax SLS009 (45 mg QW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed on or are refractory to venetoclax-based regimens. US study sites only. (Cohort completed) Group 3 Cohort 1. 45 mg QW in patients with r/r AML azacitidine SLS009 (45 mg QW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed on or are refractory to venetoclax-based regimens. US study sites only. (Cohort completed) Group 3 Cohort 2. 60 mg QW in patients with r/r AML. azacitidine SLS009 (60 mg QW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed on or are refractory to venetoclax-based regimens. US study sites only. (Cohort completed). Group 3 Cohort 4. 30 mg BIW in patients with r/r AML with ASXL1 mutation. venetoclax SLS009 (30 mg BIW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed or are refractory to venetoclax-based regimens and with documented ASXL1 mutation. Group 3 Cohort 3. 30 mg BIW in patients with r/r AML. azacitidine SLS009 (30 mg BIW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed on or are refractory to venetoclax-based regimens. US study sites only. (Cohort completed). Group 3 Cohort 3. 30 mg BIW in patients with r/r AML. venetoclax SLS009 (30 mg BIW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed on or are refractory to venetoclax-based regimens. US study sites only. (Cohort completed). Group 3 Cohort 4. 30 mg BIW in patients with r/r AML with ASXL1 mutation. azacitidine SLS009 (30 mg BIW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed or are refractory to venetoclax-based regimens and with documented ASXL1 mutation. Group 3 Cohort 5. 30 mg BIW in pts with r/rAML with other than ASXL1 mutations venetoclax SLS009 (30 mg BIW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed or are refractory to venetoclax-based regimens and with documented Defining somatic mutations, Cytogenetic abnormalities defining acute myeloid leukemia, myelodysplasia related, other than ASXL1 mutation per WHO 5th Edition classification. Group 3 Cohort 5. 30 mg BIW in pts with r/rAML with other than ASXL1 mutations azacitidine SLS009 (30 mg BIW) in combination with venetoclax and azacitidine in patients with r/r AML who have relapsed or are refractory to venetoclax-based regimens and with documented Defining somatic mutations, Cytogenetic abnormalities defining acute myeloid leukemia, myelodysplasia related, other than ASXL1 mutation per WHO 5th Edition classification.
- Primary Outcome Measures
Name Time Method Safety and Tolerability: Dose Limiting Toxicities (DLTs) 21 to 28 days The incidence of DLTs
Safety and Tolerability: adverse events (AEs) approximately 2 years The incidence and severity of all AEs
- Secondary Outcome Measures
Name Time Method Efficacy: PFS 2 years Progression-free survival
PK parameter AUC0-β approximately 3 months Area under the plasma concentration-time curve (from zero to infinity)
Efficacy: ORR 2 years Overall response rate is the proportion of patients showing anti-leukemic activity in response to treatment
PK parameter Tmax approximately 3 months Time for maximum plasma concentration reached following administration of study drug
PK parameter tΒ½ approximately 3 months Half-life of study drug
Efficacy: DOR 2 years Duration of response in patients
PK parameter Cmax approximately 3 months Maximum plasma concentration reached following administration of study drug
PK parameter AUC0-t approximately 3 months Area under the plasma concentration-time curve (from zero to the time of the last measurable concentration)
Efficacy:OS 2 years Overall survival
Trial Locations
- Locations (21)
MD Anderson
πΊπΈHouston, Texas, United States
Linyi Cancer Hospital
π¨π³Linyi, Shandong, China
The First Affiliated Hospital of Bengbu Medical College
π¨π³Bengbu, Anhui, China
Affiliated Hospital of Hebei University
π¨π³Baoding, Hebei, China
The First Affiliated Hospital of Soochow University
π¨π³Suzhou, Jiangsu, China
Shengjing Hospital Affiliated to China Medical University
π¨π³Shenyang, Liaoning, China
Blood disease hospital, Chinese Academy of Medical Science
π¨π³Tianjin, Tianjin, China
The Second Affiliated hospital of Zhejiang University School of Medicine
π¨π³Hangzhou, Zhejiang, China
Clinical Research Alliance, Inc.
πΊπΈLake Success, New York, United States
New York - Presbyterian Hospital
πΊπΈNew York, New York, United States
O'Neal Comprehensive Cancer Center, University of Alabama
πΊπΈBirmingham, Alabama, United States
UNC School of Medicine, Division of Hematology
πΊπΈChapel Hill, North Carolina, United States
Baylor Scott & White Health
πΊπΈDallas, Texas, United States
Anhui Provincial Hospital
π¨π³Hefei, Anhui, China
Affiliated Cancer Hospital of Chongqing University
π¨π³Chongqing, Chongqing, China
Cancer prevention and treatment center of Sun Yat sen University
π¨π³Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
π¨π³Guangzhou, Guangdong, China
Henan Cancer Hospital
π¨π³Zhengzhou, Henan, China
The First Affiliated Hospital Of Nanchang University
π¨π³Nanchang, Jiangxi, China
Bon Secours St. Francis Cancer Center
πΊπΈGreenville, South Carolina, United States
Ochsner Clinic Foundation
πΊπΈNew Orleans, Louisiana, United States
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