OncoMatch/Clinical Trials/NCT04588922
Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML
Is NCT04588922 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including SLS009 and venetoclax for hematologic malignancies.
Treatment: SLS009 · venetoclax · azacitidine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: ASXL1 mutation
AML, Cohort 4 (ASXL1 mutations): AML patients relapsed on and/or refractory to therapies containing venetoclax combinations and with documented ASXL1 mutation.
Required: BCOR mutation
Mutations in Cohort 5 include: BCOR, EZH2, SF3B1, SRSF2, STAG2, U2AF1 and ZRSR2.
Required: EZH2 mutation
Mutations in Cohort 5 include: BCOR, EZH2, SF3B1, SRSF2, STAG2, U2AF1 and ZRSR2.
Required: SF3B1 mutation
Mutations in Cohort 5 include: BCOR, EZH2, SF3B1, SRSF2, STAG2, U2AF1 and ZRSR2.
Required: SRSF2 mutation
Mutations in Cohort 5 include: BCOR, EZH2, SF3B1, SRSF2, STAG2, U2AF1 and ZRSR2.
Required: STAG2 mutation
Mutations in Cohort 5 include: BCOR, EZH2, SF3B1, SRSF2, STAG2, U2AF1 and ZRSR2.
Required: U2AF1 mutation
Mutations in Cohort 5 include: BCOR, EZH2, SF3B1, SRSF2, STAG2, U2AF1 and ZRSR2.
Required: ZRSR2 mutation
Mutations in Cohort 5 include: BCOR, EZH2, SF3B1, SRSF2, STAG2, U2AF1 and ZRSR2.
Required: KMT2A (MLL) rearrangement
KMT2A rearrangement: 2 points
Required: TP53 mutation
TP53mut: 1 point
Required: KRAS mutation
KRASmut: 1 point
Required: IDH2 wild-type
IDH2wt: 1 point
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: venetoclax containing regimen (venetoclax) — relapsed/refractory AML
AML (only for Group 3): Patients relapsed on or refractory to venetoclax containing regimens.
Must have received: at least 2 prior lines of systemic therapy — lymphoma
Lymphoma (Except for other leukemias): At least one measurable or evaluable lesion as defined by the Lugano (2014) response criteria. Patients must have received at least 2 prior lines of systemic therapy.
Cannot have received: CDK9 inhibitor
History of previous exposure to any other CDK9 inhibitors.
Cannot have received: allogeneic stem cell transplant
Exception: within 6 months of study entry
Prior allogeneic stem cell transplant within 6 months of study entry.
Lab requirements
Blood counts
For lymphoma: ANC ≥ 1,000/µL; for CLL/SLL: ANC ≥ 500/µL if due to BM involvement; Hemoglobin ≥ 7.5 g/dL without transfusion; Platelet count ≥ 50,000/µL without transfusion
Kidney function
Serum creatinine clearance (CrCl) ≥ 60 mL/min for adults; serum creatinine ≤ 1.5 x ULN or CrCl ≥ 50 mL/min for pediatric patients
Liver function
Total bilirubin ≤ 1.5 × ULN except Gilbert's syndrome; AST, ALT ≤2.5 × ULN (≤5 × ULN with hepatic metastases)
Cardiac function
LVEF ≥ 50%; Average QTcF < 450 msec (males) or < 470 msec (females); no severe cardiovascular disease within 6 months
Adequate hepatic function as evidenced by meeting all the following requirements: Total bilirubin ≤ 1.5 × ULN except for patients with Gilbert's syndrome...AST, ALT ≤2.5 × ULN (≤5 × ULN with hepatic metastases). Measured or calculated serum creatinine clearance (CrCl) ≥ 60 mL/min for adults or serum creatinine ≤ 1.5 x ULN; or if serum creatinine > 1.5 x ULN, then CrCl ≥ 50 mL/min for pediatric patients. Amylase ≤ 1.5 × ULN. For lymphoma, CLL/SLL patients: ANC, hemoglobin, platelet count as above. LVEF ≥ 50%; Average QTcF < 450 msec (males) or < 470 msec (females); no severe cardiovascular disease within 6 months.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- O'Neal Comprehensive Cancer Center, University of Alabama · Birmingham, Alabama
- Ochsner Clinic Foundation · New Orleans, Louisiana
- Clinical Research Alliance, Inc. · Lake Success, New York
- New York - Presbyterian Hospital · New York, New York
- UNC School of Medicine, Division of Hematology · Chapel Hill, North Carolina
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