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

This study is testing a new drug called APVO436 combined with standard chemotherapy (azacitidine or azacitidine + venetoclax) for older or less fit patients with newly diagnosed acute myeloid leukemia (AML) — a cancer of the blood and bone marrow. APVO436 is a bispecific antibody that targets CD123 on leukemia cells and helps the immune system attack them. This study is for patients who cannot tolerate standard intensive chemotherapy. **You may be eligible if...** - You are 18 or older with newly diagnosed AML that has not been previously treated - Your leukemia cells carry the CD123 protein - You are considered unfit for intensive chemotherapy due to age (75+), physical function limitations, or organ function issues (heart, lungs, kidneys, or liver) - You have an expected survival of at least 12 weeks **You may NOT be eligible if...** - You have received prior treatment for AML, a related blood disorder, or a bone marrow condition - You have received a stem cell transplant or CAR-T therapy - You have acute promyelocytic leukemia (a specific type) - You have AML that evolved from a chronic blood cancer like myelofibrosis or CML - You have active autoimmune disease requiring high-dose steroids - You have very low kidney function (creatinine clearance below 30 mL/min) - You have significant liver disease (bilirubin or liver enzymes above defined thresholds) Talk to your doctor to see if this trial is right for you.