A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04755244|
Recruitment Status : Active, not recruiting
First Posted : February 16, 2021
Last Update Posted : June 9, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia AML, Adult||Drug: evorpacept Drug: venetoclax Drug: azacitidine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||97 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Study of Evorpacept (ALX148) in Combination With Venetoclax and Azacitidine in Patients With Acute Myeloid Leukemia (AML) (ASPEN-05)|
|Actual Study Start Date :||May 5, 2021|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: evorpacept (ALX148) + venetoclax + azacitidine
Phase 1a: Participants will receive escalating doses of evorpacept (ALX148) in combination with venetoclax and azacitidine
Phase 1b/2: Participants will receive evorpacept (ALX148) at the recommended Phase 2 dose in combination with venetoclax and azacitidine
Fusion protein that blocks CD47-SIRPalpha pathway
Other Name: ALX148
Other Name: Venclexta
Hypomethylating agent (HMA)
Other Name: Vidaza
- Phase 1: Dose Limiting Toxicities (DLT) [ Time Frame: Up to 28 days ]Number of participants with a DLT
- Phase 2: Composite complete remission rate (CRc) [ Time Frame: Approximately 6 months ]Number of participants achieving a complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) per European LeukemiaNet (ELN) 2017 criteria
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Cytologically or histologically confirmed diagnosis of relapsed/refractory or newly diagnosed AML per WHO 2016 classification.
- Phase 1a: AML that is relapsed/refractory or that is previously untreated in patients not considered suitable for intensive induction therapy.
- Phase 1b: AML that is relapsed/refractory after prior treatment with a HMA-based regimen.
- Phase 2: Previously untreated AML in patients who are not considered suitable candidates for intensive induction therapy.
- Adequate renal and liver function.
- Age ≥18 years.
- Adequate performance status.
- In Phase 1a and 1b, patients that have undergone prior allo-HSCT must be at least 3 months post-HSCT, without uncontrolled graft-versus-host disease (GVHD). For Phase 2, patients that have undergone prior allo-HSCT are excluded.
- Patients with newly diagnosed AML with favorable risk cytogenetics such as t(8;21), inv(16), or t(16;16) as per the NCCN Guidelines Version 3, 2019 for AML.
- Patients with acute promyelocytic leukemia (APL).
- Prior treatment with any anti-CD47 or anti-SIRPalpha (signal regulatory protein alpha) agent.
- Known active viral infections, including hepatitis B and C, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS) related illness, or SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04755244
|United States, Illinois|
|Northwestern University Feinberg School of Medicine|
|Chicago, Illinois, United States, 60611|
|United States, New York|
|Roswell Park Comprehensive Cancer Center|
|Buffalo, New York, United States, 14263|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Responsible Party:||ALX Oncology Inc.|
|Other Study ID Numbers:||
|First Posted:||February 16, 2021 Key Record Dates|
|Last Update Posted:||June 9, 2022|
|Last Verified:||February 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action