- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04417517
A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02)
August 11, 2023 updated by: ALX Oncology Inc.
A Phase 1/2 Study of Evorpacept (ALX148) in Combination With Azacitidine in Patients With Higher Risk Myelodysplastic Syndrome (MDS) (ASPEN-02)
This Phase 1/2 clinical study will evaluate evorpacept (ALX148) in combination with azacitidine for the treatment of patients with higher risk myelodysplastic syndrome (MDS).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The Phase 1 will consist of a dose escalation of evorpacept (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 evorpacept (ALX148) in combination with azacitidine compared to azacitidine alone for patients with previously untreated higher risk MDS.
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Abraham Fong, MD, PhD
- Phone Number: (650)466-7125
- Email: info@alxoncology.com
Study Locations
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Seoul, Korea, Republic of
- Seoul National University Hospital
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Seoul, Korea, Republic of
- Asan Medical Center
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Seoul, Korea, Republic of
- Samsung Medical Center
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Seoul, Korea, Republic of
- Severance Hospital
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Seoul, Korea, Republic of
- Seoul Saint Mary's Hospital
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Alicante, Spain, 03010
- Hospital General Universitario de Alicante
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Cáceres, Spain, 10003
- Hospital San Pedro de Alcántara
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Salamanca, Spain, 37007
- Hospital Universitario de Salamanca
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Valencia, Spain, 46026
- Hospital Universitari i Politecnic La Fe de Valencia
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California
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Los Angeles, California, United States, 90033
- University of Southern California, Norris Comprehensive Cancer Center
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University Feinberg School of Medicine
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Indiana
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Indianapolis, Indiana, United States, 46202
- IU Simon Cancer Center
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Michigan
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Grand Rapids, Michigan, United States, 49546
- Start Midwest
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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North Carolina
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Charlotte, North Carolina, United States, 28204
- Levine Cancer Institute
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Tennessee
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Nashville, Tennessee, United States, 37203
- Vanderbilt University Medical Center
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Texas
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Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
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Washington
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Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: evorpacept (ALX148) + azacitidine
Phase 1: Participants will receive escalating doses of evorpacept (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 evorpacept (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 |
Fusion protein that blocks CD47-SIRPalpha pathway
Other Names:
Hypomethylating agent (HMA)
Other Names:
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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
|
Hypomethylating agent (HMA)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase 1: Dose Limiting Toxicities (DLT)
Time Frame: Up to 28 days
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Number of participants with a DLT
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Up to 28 days
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Phase 2: Complete response rate (CRR)
Time Frame: Approximately 6 months
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Number of participants achieving a complete response per International Working Group (IWG) criteria
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Approximately 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 2, 2020
Primary Completion (Estimated)
December 31, 2023
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
June 2, 2020
First Submitted That Met QC Criteria
June 2, 2020
First Posted (Actual)
June 4, 2020
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 11, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AT148002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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