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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Sellas Life Sciences Group
Study ID
NCT04588922
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Hematologic Malignancies

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SLS009 — DRUG
    Solution for injection
  • venetoclax — DRUG
    Tablets
  • azacitidine — DRUG
    Solution for injection

Study Details

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.

Key Dates

Start date
May 10, 2021
Status verified
Mar 2026
Primary completion
Dec 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1. Dose escalation in patients with r/r AML
    In the dose escalation part, the dose levels will be escalated following the Bayesian optimal interval (BOIN) design. China study sites only. (Completed).
  • Experimental: Group 2. Dose escalation in patients with r/r CLL/SLL or lymphoma
    In the dose escalation part, the dose levels will be escalated following the Bayesian optimal interval (BOIN) design. China and US study sites. (Completed).
  • Experimental: Group 3 Cohort 1. 45 mg QW in patients with r/r AML
    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)
  • Experimental: Group 3 Cohort 2. 60 mg QW in patients with r/r AML.
    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).
  • Experimental: Group 3 Cohort 3. 30 mg BIW in patients with r/r AML.
    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).
  • Experimental: Group 3 Cohort 4. 30 mg BIW in patients with r/r AML with ASXL1 mutation.
    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.
  • Experimental: Group 3 Cohort 5. 30 mg BIW in pts with r/rAML with other than ASXL1 mutations
    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.
  • Experimental: Group 4 (treatment arm): SLS009, venetoclax, azacitidine
    SLS009 (30 mg BIW) in combination with venetoclax and azacitidine in patients with newly diagnosed AML less likely to benefit from standard venetoclax and azacitidine therapy based on molecular profiling.
  • Active Comparator: Group 4 (control arm): venetoclax and azacitidine
    Venetoclax and azacitidine in patients with newly diagnosed AML less likely to benefit from standard venetoclax and azacitidine therapy based on molecular profiling.
  • Experimental: Group 5 (treatment arm): SLS009, venetoclax, azacitidine (not yet recruiting)
    SLS009 (30 mg BIW) in combination with venetoclax and azacitidine in patients with newly diagnosed AML. Patients who initiate treatment with venetoclax and azacitidine but demonstrate a confirmed lack of any response after two treatment cycles.
  • Active Comparator: Group 5 (control arm): venetoclax and azacitidine (not yet recruiting)
    Venetoclax and azacitidine in patients with newly diagnosed AML. Patients who initiate treatment with venetoclax and azacitidine but demonstrate a confirmed lack of any response after two treatment cycles.

Primary Outcome Measure

Safety and Tolerability: Dose Limiting Toxicities (DLTs) [ Time Frame: 21 to 28 days ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
O'Neal Comprehensive Cancer Center, University of AlabamaBirminghamAlabama35233
Omer Jamy, MD
City of Hope - PhoenixGoodyearArizona85338
Misam Ziwat
City of Hope National Medical CenterDuarteCalifornia91010
Amanda Blackmon
City of Hope - AtlantaNewnanGeorgia30265
Sabarish Ayyappan
City of Hope - ChicagoZionIllinois60099
Neil Dunavin
Ochsner Clinic FoundationNew OrleansLouisiana70121-
Clinical Research Alliance, Inc.Lake SuccessNew York11042-
New York - Presbyterian HospitalNew YorkNew York10032-
UNC School of Medicine, Division of HematologyChapel HillNorth Carolina27599
Joshua Zeidner, MD
Bon Secours St. Francis Cancer CenterGreenvilleSouth Carolina29607
Sharif Khan, MD
Baylor Scott & White HealthDallasTexas75246
William Christensen, MD
MD AndersonHoustonTexas77091
Tapan Kadia, MD

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