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

Primary Purpose

Higher Risk Myelodysplastic Syndromes

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
evorpacept
azacitidine
Sponsored by
ALX Oncology Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Higher Risk Myelodysplastic Syndromes focused on measuring ALX148, MDS, CD47, Azacitidine, HMA, SIRP-alpha, evorpacept, High risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Southern California, Norris Comprehensive Cancer Center
  • Northwestern University Feinberg School of Medicine
  • IU Simon Cancer Center
  • START Midwest
  • Mayo Clinic
  • Levine Cancer Institute
  • Duke University Medical Center
  • Vanderbilt University Medical Center
  • University of Texas MD Anderson Cancer Center
  • Fred Hutchinson Cancer Research Center
  • Asan Medical Center
  • Samsung Medical Center
  • Seoul National University Hospital
  • Seoul Saint Mary's Hospital
  • Severance Hospital
  • Hospital General Universitario de Alicante
  • Hospital San Pedro de Alcantara
  • Hospital Universitario de Salamanca
  • Hospital Universitari i Politecnic La Fe de Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

evorpacept (ALX148) + azacitidine

azacitidine

Arm Description

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

Phase 2 only: Participants will receive azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28-day cycle

Outcomes

Primary Outcome Measures

Phase 1: Dose Limiting Toxicities (DLT)
Number of participants with a DLT
Phase 2: Complete response rate (CRR)
Number of participants achieving a complete response per International Working Group (IWG) criteria

Secondary Outcome Measures

Full Information

First Posted
June 2, 2020
Last Updated
August 11, 2023
Sponsor
ALX Oncology Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04417517
Brief Title
A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02)
Official Title
A Phase 1/2 Study of Evorpacept (ALX148) in Combination With Azacitidine in Patients With Higher Risk Myelodysplastic Syndrome (MDS) (ASPEN-02)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Higher Risk Myelodysplastic Syndromes
Keywords
ALX148, MDS, CD47, Azacitidine, HMA, SIRP-alpha, evorpacept, High risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
evorpacept (ALX148) + azacitidine
Arm Type
Experimental
Arm Description
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
Arm Title
azacitidine
Arm Type
Active Comparator
Arm Description
Phase 2 only: Participants will receive azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28-day cycle
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)
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: Complete response rate (CRR)
Description
Number of participants achieving a complete response per International Working Group (IWG) 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: 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).
Facility Information:
Facility Name
University of Southern California, Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
IU Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
START Midwest
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
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
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Saint Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital San Pedro de Alcantara
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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