This clinical trial is for men and women with acute myeloid leukemia (AML) whose cancer has been treated before and has either recurred or did not respond to prior therapy.   

This is one of the first-in-human studies to try to understand how an investigational drug called BP1002 works in the human body and if BP1002 could help cancer patients in the future. Investigational means that BP1002 has not yet been approved by the U.S. Food and Drug Administration (FDA).

The purpose of this study is to determine the highest dose of BP1002 that is tolerated by patients and whether BP1002 is safe for people to receive. Additionally, the study will look at whether BP1002 is effective in treating AML, and if BP1002 can be combined safety with another common cancer medication called decitabine. The study will measure the amount of BP1002 in participant’s blood at various time points, how BP1002 acts in participants, and the amount of anti-drug antibodies (substances produced by the body that recognize foreign substances in the blood).

There are two parts (phases) of the study. Each participant will only be enrolled in one of the phases, which will be discussed with the study team prior to participation. 

The Dose Escalation Phase (Part 1) will use increasing doses of BP1002 to determine the recommended dose for future studies of the drug. The dose level a participant receives will depend on when they enter the study and will not change. Once the dose level is identified in the Dose Escalation Phase, the study will move into the Dose Expansion Phase (Part 2). In this part of the study, BP1002 will be given with a common AML chemotherapy called decitabine to see if both drugs are safe to give together.

Participants in both parts of the study will receive an IV infusion of BP1002 twice a week for a total of 8 doses per month. The IV infusion will last 2-3 hours. If participants tolerate the dose, they may repeat the dosing cycle every 4 weeks as long as the study doctor considers the study regimen to be safe.
   
Study participation will last approximately 24 months, but participants may continue in the study for longer than 24 months if they are experiencing an improvement in their condition.