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A Study of ALX148 With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02)

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ClinicalTrials.gov Identifier: NCT04417517
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
ALX Oncology Inc.

Brief Summary:
This Phase 1/2 clinical study will evaluate ALX148 in combination with azacitidine for the treatment of patients with higher risk myelodysplastic syndrome (MDS).

Condition or disease Intervention/treatment Phase
Higher Risk Myelodysplastic Syndromes Drug: ALX148 Drug: Azacitidine Phase 1 Phase 2

Detailed Description:
The Phase 1 will consist of a dose escalation of ALX148 in combination with azacitidine to evaluate safety and tolerability, and to identify the recommended Phase 2 dose of ALX148 in combination with azacitidine. The Phase 2 will evaluate the efficacy of ALX148 in combination with azacitidine compared to azacitidine alone for patients with previously untreated higher risk MDS.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of ALX148 in Combination With Azacitidine in Patients With Higher Risk Myelodysplastic Syndrome (MDS) (ASPEN-02)
Actual Study Start Date : October 2, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Azacitidine

Arm Intervention/treatment
Experimental: ALX148 + azacitidine

Phase 1: Participants will receive escalating doses of ALX148 in combination with azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28 day cycle

Phase 2: Participants will receive ALX148 at the recommended Phase 2 dose in combination with azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28-day cycle

Drug: ALX148
Fusion protein that blocks CD47-SIRPalpha pathway

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

Active Comparator: Azacitidine
Phase 2 only: Participants will receive azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28-day cycle
Drug: Azacitidine
Hypomethylating agent (HMA)
Other Name: Vidaza




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: Complete response rate (CRR) [ Time Frame: Approximately 6 months ]
    Number of participants achieving a complete response per International Working Group (IWG) criteria



Information from the National Library of Medicine

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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:

  • Phase 1: Diagnosis of higher risk MDS that is either previously untreated or relapsed/refractory.
  • Phase 2: Diagnosis of higher risk MDS that is previously untreated.
  • Adequate renal and liver function.
  • Age ≥18 years.
  • Adequate performance status.

Exclusion Criteria:

  • Previous allogeneic hematopoietic stem cell transplant (allo-HSCT) for MDS or AML.
  • Prior treatment with any anti-CD47 or anti-SIRPα (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).

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): NCT04417517


Contacts
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Contact: Abraham Fong, MD, PhD (650)466-7125 info@alxoncology.com

Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
United States, Indiana
IU Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Sponsors and Collaborators
ALX Oncology Inc.
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Responsible Party: ALX Oncology Inc.
ClinicalTrials.gov Identifier: NCT04417517    
Other Study ID Numbers: AT148002
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021
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
MDS
CD47
Azacitidine
HMA
SIRP-alpha
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors