ALX Oncology 148005: I/II of ALX148 in combo with Venetoclax and AZA in AML (Leukemia) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called ALX148 (evorpacept) is a safe and effective treatment for people with AML. The study drug will be combined with azacitidine (AZA) and venetoclax (VEN), which are standard drugs used to treat AML.

What is the Condition Being Studied?

Acute Myeloid Leukemia (AML)

Who Can Participate in the Study?

Adults diagnosed with AML who:
- Have relapsed from previous treatment; OR
- Did not have an adequate response to standard treatments; OR
- Have not received treatment yet

For more information about who can join this study, please contact the study team at 919-660-2077.

Age Group
Adults

What is Involved?

If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:
- Have a physical exam
- Have a heart scan (ECG)
- Have blood draws
- Have bone marrow samples taken

After the screening period, this study is divided into 2 different phases. During Phase 1a, increasing doses of the study drug will be given together with AZA and VEN. During Phase 1b/2, the study drug will be given at a dose selected from Phase 1a in combination with AZA and VEN. Whether you participate in Phase 1a or Phase 1b/2 depends on when you join the study.

In either phase of the study, you will:
- Receive the study drug as an infusion (IV) either every 2 or 4 weeks
- Receive AZA as an infusion or injection (shot) once daily for a 7-day period every 4 weeks
- Take VEN by mouth once a day

Once you stop taking the study drug, you will enter a follow up period. The study team will call you approximately every 8 weeks for up to 3 years to see how you are feeling.

Study Details

Full Title
A PHASE 1/2 STUDY OF ALX148 IN COMBINATION WITH VENETOCLAX AND AZACITIDINE IN PATIENTS WITH ACUTE MYELOID LEUKEMIA (AML) (ASPEN-05)
Principal Investigator
Hematologic Oncologist
Protocol Number
IRB: PRO00107742
NCT: NCT04755244
Phase
Phase I/II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698