Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 developed for the treatment of hematologic malignancies, including high-risk newly diagnosed acute myeloid leukemia (AML). It is currently in Phase 1 clinical development and has not been approved by the FDA.
SLS009 targets the WT1 protein, a transcription factor involved in hematologic malignancies. By inhibiting WT1, SLS009 aims to disrupt cancer cell growth and survival. This targeted approach is being studied in patients with hematologic malignancies, including AML.
SLS009 is being developed by SELLAS Life Sciences Group, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol SLS. The company is conducting clinical trials to evaluate the safety and efficacy of SLS009 in patients with hematologic malignancies.
SLS009 is currently in Phase 1 clinical development. It is an investigational drug being studied in a Phase 1 trial (NCT04588922) for hematologic malignancies, including high-risk newly diagnosed AML. The drug has not yet been approved by regulatory authorities.
SLS009 is being evaluated in a Phase 1 clinical trial with the identifier NCT04588922. This study is recruiting patients with hematologic malignancies, including high-risk newly diagnosed AML, and is being conducted in the United States and China. The trial aims to enroll 160 participants.
Yes, SLS009 was formerly known as GFH009. The drug is being developed by SELLAS Life Sciences Group, Inc. under the name SLS009, and it is the same investigational CDK9 inhibitor studied in clinical trials for hematologic malignancies.