APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML
Trial Parameters
Eligibility Fast-Check
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Brief Summary
A multi-center, open-label, dose-finding study of five dose levels of APVO436 in combination with venetoclax and azacitidine (ven/aza) in adult patients with newly diagnosed, CD123+ AML.
Eligibility Criteria
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 at diagnosis is acceptable. 4\. Patient must be considered ineligible for induction therapy defined by at least one of the following: 1. ≥75 years of age 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3 3. Cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina) 4. Pulmonary disorder (e.g., DLCO ≤65% or FEV1 ≤65%) 5. Creatinine clearance 30-45 mL/min based on Cockcroft-Gault or Modified of Diet in Renal Disease (MDRD) formular 6. Hepatic disorder with total bilirubin between 1.5 and 3 times the ULN 5. Patient must have a projected life expectancy of ≥12 weeks Exclusion Criteria: 1. Patient has received trea