Back to resultsA Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)
Primary Purpose
Acute Myeloid Leukemia, AML, Adult
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
evorpacept
venetoclax
azacitidine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring ALX148, CD47, SIRPalpha, azacitidine, venetoclax, evorpacept
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- Northwestern University Feinberg School of Medicine
- Roswell Park Comprehensive Cancer Center
- Duke University Medical Center
- Vanderbilt University Medical Center
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
evorpacept (ALX148) + venetoclax + azacitidine
Arm Description
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
Outcomes
Primary Outcome Measures
Phase 1: Dose Limiting Toxicities (DLT)
Number of participants with a DLT
Phase 2: Composite complete remission rate (CRc)
Number of participants achieving a complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) per European LeukemiaNet (ELN) 2017 criteria
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04755244
Brief Title
A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
May 5, 2023 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ALX Oncology Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, AML, Adult
Keywords
ALX148, CD47, SIRPalpha, azacitidine, venetoclax, evorpacept
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
evorpacept (ALX148) + venetoclax + azacitidine
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
evorpacept
Other Intervention Name(s)
ALX148
Intervention Description
Fusion protein that blocks CD47-SIRPalpha pathway
Intervention Type
Drug
Intervention Name(s)
venetoclax
Other Intervention Name(s)
Venclexta
Intervention Description
BCL-2 inhibitor
Intervention Type
Drug
Intervention Name(s)
azacitidine
Other Intervention Name(s)
Vidaza
Intervention Description
Hypomethylating agent (HMA)
Primary Outcome Measure Information:
Title
Phase 1: Dose Limiting Toxicities (DLT)
Description
Number of participants with a DLT
Time Frame
Up to 28 days
Title
Phase 2: Composite complete remission rate (CRc)
Description
Number of participants achieving a complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) per European LeukemiaNet (ELN) 2017 criteria
Time Frame
Approximately 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Roswell Park Comprehensive Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)
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