A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)
Study Details
Study Description
Brief Summary
This Phase 1/2 clinical study will evaluate evorpacept (ALX148) in combination with venetoclax and azacitidine for the treatment of patients with acute myeloid leukemia (AML).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1/Phase 2 |
Detailed Description
The Phase 1 will consist of a dose escalation of evorpacept (ALX148) in combination with venetoclax and azacitidine to evaluate safety and tolerability, and to identify the recommended Phase 2 dose of evorpacept (ALX148) in combination with venetoclax and azacitidine. The Phase 2 will evaluate the efficacy of evorpacept (ALX148) in combination with venetoclax and azacitidine for patients with AML.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
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 |
Drug: evorpacept
Fusion protein that blocks CD47-SIRPalpha pathway
Other Names:
Drug: venetoclax
BCL-2 inhibitor
Other Names:
Drug: azacitidine
Hypomethylating agent (HMA)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Phase 1: Dose Limiting Toxicities (DLT) [Up to 28 days]
Number of participants with a DLT
- Phase 2: Composite complete remission rate (CRc) [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Cytologically or histologically confirmed diagnosis of relapsed/refractory or newly diagnosed AML per WHO 2016 classification.
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Phase 1a: AML that is relapsed/refractory or that is previously untreated in patients not considered suitable for intensive induction therapy.
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Phase 1b: AML that is relapsed/refractory after prior treatment with a HMA-based regimen.
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Phase 2: Previously untreated AML in patients who are not considered suitable candidates for intensive induction therapy.
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Adequate renal and liver function.
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Age ≥18 years.
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Adequate performance status.
Exclusion Criteria:
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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.
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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.
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Patients with acute promyelocytic leukemia (APL).
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Prior treatment with any anti-CD47 or anti-SIRPalpha (signal regulatory protein alpha) agent.
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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).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Northwestern University Feinberg School of Medicine | Chicago | Illinois | United States | 60611 |
2 | Roswell Park Comprehensive Cancer Center | Buffalo | New York | United States | 14263 |
3 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
4 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37203 |
5 | University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- ALX Oncology Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AT148005