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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04417517
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : October 19, 2020
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 October 19, 2020
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: 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
Original Primary Outcome Measures  ICMJE Same as current
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 ALX148 With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02)
Official Title  ICMJE A Phase 1/2 Study of 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 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 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 for patients with previously untreated higher risk MDS.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Higher Risk Myelodysplastic Syndromes
Intervention  ICMJE
  • Drug: ALX148
    Fusion protein that inhibits the CD47-SIRPalpha signaling pathway
  • Drug: Azacitidine
    Hypomethylating agent (HMA)
    Other Name: Vidaza
Study Arms  ICMJE 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)

Interventions:
  • Drug: ALX148
  • 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: June 2, 2020)
63
Original Estimated Enrollment  ICMJE Same as current
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 Not Provided
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 October 2020

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