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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06634394 | APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML | PHASE1 | RECRUITING | 39 | — | — | Oct 1, 2024 | Mar 1, 2028 | May 11, 2025 | 7 | United States |
Incidence and severity of treatment emergent adverse events (TEAEs), including ≥Grade 3 adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs: ≥Grade 2 infusion related reaction (IRR), ≥Grade 2 cardiac toxicity, and ≥Grade 2 neurotoxicity as complication of cytokine release syndrome \[CRS\]).
| Arm | Type | Description |
|---|---|---|
| Treatment Arm APVO436 in combination with Venetoclax and Azacitidine | EXPERIMENTAL | APVO436 at escalating dose levels in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, CD123+ AML. |
| Name | Type | Description |
|---|---|---|
| APVO436 | DRUG | Infusion drug administered as a 4 hour infusion. |
| Venetoclax | DRUG | Oral tablet given on days 1 through 22, of a 28 day cycle. |
| Azacitidine | DRUG | Intravenous infusion given on days 1-8 of a 28 day cycle |
Inclusion Criteria: * 1\. Age ≥18 years. 2. Patient must have confirmation of AML based on 2016 World Health Organization (WHO) criteria and not been previously treated. 3\. Patients must have CD123-positive AML as confirmed by local flow cytometry (or immunohistochemistry \[IHC\]). Confirmation...