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A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)

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ClinicalTrials.gov Identifier: NCT04755244
Recruitment Status : Active, not recruiting
First Posted : February 16, 2021
Last Update Posted : June 9, 2022
Sponsor:
Information provided by (Responsible Party):
ALX Oncology Inc.

Study Description
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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
Acute Myeloid Leukemia AML, Adult Drug: evorpacept Drug: venetoclax Drug: azacitidine 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 97 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: ALX148

Drug: venetoclax
BCL-2 inhibitor
Other Name: Venclexta

Drug: azacitidine
Hypomethylating agent (HMA)
Other Name: Vidaza


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1: Dose Limiting Toxicities (DLT) [ Time Frame: Up to 28 days ]
    Number of participants with a DLT

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
ALX Oncology Inc.
More Information
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Responsible Party: ALX Oncology Inc.
ClinicalTrials.gov Identifier: NCT04755244    
Other Study ID Numbers: AT148005
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ALX Oncology Inc.:
ALX148
CD47
SIRPalpha
 azacitidine
venetoclax
evorpacept
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Azacitidine
 Venetoclax
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors