Study of APVO436 with Venetoclax and Azacitidine for Adults Newly Diagnosed with CD123 Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating APVO436 in combination with venetoclax and azacitidine for adults newly diagnosed with CD123-positive acute myeloid leukemia AML. This study is a Phase 1b2 open-label trial designed to find the safest and most effective dose of APVO436 when used with these drugs. The trial focuses on patients who have not received prior treatment and are considered ineligible for standard induction therapy due to factors like age or health conditions. Treatment involves five dose levels of APVO436 given with venetoclax and azacitidine. In the first 28-day cycle, patients receive four initial priming doses of APVO436 to reduce the risk of cytokine release syndrome, followed by doses administered on day 15 and in subsequent cycles. APVO436 is given by a 4-hour intravenous infusion, venetoclax is taken orally on days 1 through 22, and azacitidine is delivered by IV infusion on days 1 to 8 of each 28-day cycle. Participants will attend regular treatment cycles where safety, tolerability, and dosing effects are closely monitored through clinical assessments. Researchers will evaluate the maximum tolerated dose and measure treatment efficacy over approximately one year. The study includes detailed monitoring of side effects and patient response to the combination therapy, with ongoing follow-up until study completion.

APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML