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A Study of Evorpacept (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 : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
ALX Oncology Inc.

Tracking Information
First Submitted Date  ICMJE June 2, 2020
First Posted Date  ICMJE June 4, 2020
Last Update Posted Date August 25, 2021
Actual Study Start Date  ICMJE October 2, 2020
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2021)
  • Phase 1: Dose Limiting Toxicities (DLT) [ Time Frame: Up to 28 days ]
    Number of participants with a DLT
  • Phase 2: Complete response rate (CRR) [ Time Frame: Approximately 6 months ]
    Number of participants achieving a complete response per International Working Group (IWG) criteria
Original Primary Outcome Measures  ICMJE
 (submitted: June 2, 2020)
  • Phase 1: Dose Limiting Toxicities (DLT) [ Time Frame: Up to 28 days ]
    Number of participants with a DLT
  • Phase 2: Objective response rate (ORR) [ Time Frame: Approximately 6 months ]
    Number of participants achieving a response per International Working Group (IWG) criteria
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02)
Official Title  ICMJE A Phase 1/2 Study of Evorpacept (ALX148) in Combination With Azacitidine in Patients With Higher Risk Myelodysplastic Syndrome (MDS) (ASPEN-02)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Higher Risk Myelodysplastic Syndromes
Intervention  ICMJE
  • Drug: evorpacept
    Fusion protein that blocks CD47-SIRPalpha pathway
    Other Name: ALX148
  • Drug: azacitidine
    Hypomethylating agent (HMA)
    Other Name: Vidaza
Study Arms  ICMJE
  • 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

    Interventions:
    • Drug: evorpacept
    • Drug: azacitidine
  • 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
    Intervention: Drug: azacitidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2021)
173
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2020)
63
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Abraham Fong, MD, PhD (650)466-7125 info@alxoncology.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04417517
Other Study ID Numbers  ICMJE AT148002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ALX Oncology Inc.
Study Sponsor  ICMJE ALX Oncology Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ALX Oncology Inc.
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP