Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GFH009
SLS009 · 1 trial · 1 indication
The incidence of DLTs
The incidence and severity of all AEs
Overall response rate is the proportion of patients showing anti-leukemic activity in response to treatment
| Arm | Type | Description |
|---|---|---|
| Group 1. Dose escalation in patients with r/r AML | EXPERIMENTAL | In the dose escalation part, the dose levels will be escalated following the Bayesian optimal interval (BOIN) design. China study sites only. (Completed). |
| Group 2. Dose escalation in patients with r/r CLL/SLL or lymphoma | EXPERIMENTAL | 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 1. 45 mg QW in patients with r/r AML | EXPERIMENTAL | 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. | EXPERIMENTAL | 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 3. 30 mg BIW in patients with r/r AML. | EXPERIMENTAL | 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. | EXPERIMENTAL | 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 | EXPERIMENTAL | 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 4 (treatment arm): SLS009, venetoclax, azacitidine | EXPERIMENTAL | 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. |
| Group 4 (control arm): venetoclax and azacitidine | ACTIVE_COMPARATOR | Venetoclax and azacitidine in patients with newly diagnosed AML less likely to benefit from standard venetoclax and azacitidine therapy based on molecular profiling. |
| Group 5 (treatment arm): SLS009, venetoclax, azacitidine (not yet recruiting) | EXPERIMENTAL | 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. |
| Group 5 (control arm): venetoclax and azacitidine (not yet recruiting) | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| SLS009 | DRUG | Solution for injection |
| venetoclax | DRUG | Tablets |
| azacitidine | DRUG | Solution for injection |
Inclusion Criteria For Groups 1, 2, 3, 4 and 5: Patients eligible for inclusion must meet all of the following criteria: 1. Male or female ≥ 18 years. For Group 3 Cohorts 4 and 5 only male or female ≥18 years and pediatric patients 12-18 years and ≥40 kg body mass 2. Written informed consent must...
SLS009 is an investigational small molecule being studied for the treatment of hematologic malignancies, including high-risk newly diagnosed acute myeloid leukemia (AML). It is being developed by SELLAS Life Sciences Group, Inc. and is currently in Phase 1 clinical development.
SLS009 targets WT1, a protein that is overexpressed in certain hematologic malignancies. By targeting WT1, SLS009 aims to interfere with cancer cell growth and survival. The drug is described as a highly selective CDK9 inhibitor.
SLS009 is being developed by SELLAS Life Sciences Group, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol SLS. The company is focused on developing novel therapeutics for cancer indications.
SLS009 is in Phase 1 clinical development. The ongoing trial is a Phase 1 study evaluating the drug in patients with hematologic malignancies and high-risk newly diagnosed AML. It is currently recruiting participants.
SLS009 is being evaluated in a Phase 1 clinical trial, NCT04588922, titled "Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML." The trial is recruiting with an estimated enrollment of 160 participants across the United States and China.
Yes, SLS009 was formerly known as GFH009. The drug is a highly selective CDK9 inhibitor being developed for hematologic malignancies. References to GFH009 in clinical trial listings refer to the same investigational compound now called SLS009.