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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04629443 | Phase I/II Trial of S64315 Plus Azacitidine in Acute Myeloid Leukaemia | PHASE1 | COMPLETED | 17 | — | — | Feb 17, 2021 | Aug 25, 2023 | Jun 6, 2024 | 7 | United States, Australia +2 |
| NCT03672695 | Phase I Dose Escalation Study of Intravenously Administered S64315 in Combination With Orally Administered Venetoclax in Patients With Acute Myeloid Leukaemia. | PHASE1 | COMPLETED | 37 | — | — | Nov 28, 2018 | May 30, 2023 | Feb 5, 2024 | 7 | United States, Australia +1 |
Incidence of DLTs starting from the Lead-In Dose period to the end of the first cycle of treatment of S64315 in combination with azacitidine.
Incidence and severity of AEs according to NCI CTCAE v5.0
Incidence and severity of SAEs according to NCI CTCAE v5.0
| Arm | Type | Description |
|---|---|---|
| S64315 (also referred as MIK665) with azacitidine | EXPERIMENTAL | - |
| Initial Schedule - S64315 low dose and venetoclax high dose administered in combination | EXPERIMENTAL | - |
| Initial Schedule - S64315 medium dose and venetoclax low dose administered in combination | EXPERIMENTAL | - |
| Initial Schedule - S64315 medium dose and venetoclax medium dose administered in combination | EXPERIMENTAL | - |
| Initial Schedule - S64315 medium dose and venetoclax high dose administered in combination | EXPERIMENTAL | - |
| Initial Schedule - S64315 high dose and venetoclax medium dose administered in combination | EXPERIMENTAL | - |
| Alternative Schedule - Venetoclax medium dose administered with no S64315 | EXPERIMENTAL | - |
| Alternative Schedule - S64315 medium dose and venetoclax medium dose administered in combination | EXPERIMENTAL | - |
| Alternative Schedule - S64315 high dose and venetoclax low dose administered in combination | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| S 64315 (also referred as MIK665) and azacitidine | DRUG | The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours. During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days. |
| S 64315 (also referred as MIK665) and venetoclax | COMBINATION_PRODUCT | The treatment combination period can only begin after the planned dose of venetoclax is reached. Depending on the administration dosing schedule, the combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) during which the patient continues to receive venetoclax daily. Once the planned dose of both drugs is reached the schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen for venetoclax. S64315 should be administered 2 to 4 hours after venetoclax intake, via IV infusion. The dose escalation will start at 50 mg once a week and doses up to 250 mg once a week might be explored. Venetoclax will be administered orally once a day. The dose escalation will start at 100 mg daily and doses up to 600 mg daily might be explored. Venetoclax must be taken with a meal (ideally during breakfast) in order to avoid reduced efficacy. |
Inclusion Criteria: 1. Patients aged ≥ 18 years 2. Patients with cytologically confirmed and documented de novo, secondary or therapy-related AML as defined by World Health Organization 2016 classification (Arber, 2016) excluding acute promyelocytic leukaemia (APL, French American-British M3 classi...