Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04588922 | Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML | PHASE1 | RECRUITING | 160 | — | — | May 10, 2021 | Dec 31, 2027 | May 1, 2026 | 25 | United States, China |
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...