<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04417517</url>
  </required_header>
  <id_info>
    <org_study_id>AT148002</org_study_id>
    <nct_id>NCT04417517</nct_id>
  </id_info>
  <brief_title>A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02)</brief_title>
  <official_title>A Phase 1/2 Study of Evorpacept (ALX148) in Combination With Azacitidine in Patients With Higher Risk Myelodysplastic Syndrome (MDS) (ASPEN-02)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ALX Oncology Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ALX Oncology Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Phase 1/2 clinical study will evaluate evorpacept (ALX148) in combination with&#xD;
      azacitidine for the treatment of patients with higher risk myelodysplastic syndrome (MDS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Phase 1 will consist of a dose escalation of evorpacept (ALX148) in combination with&#xD;
      azacitidine to evaluate safety and tolerability, and to identify the recommended Phase 2 dose&#xD;
      of ALX148 in combination with azacitidine. The Phase 2 will evaluate the efficacy of&#xD;
      evorpacept (ALX148) in combination with azacitidine compared to azacitidine alone for&#xD;
      patients with previously untreated higher risk MDS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 2, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phase 1: Dose Limiting Toxicities (DLT)</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Number of participants with a DLT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2: Complete response rate (CRR)</measure>
    <time_frame>Approximately 6 months</time_frame>
    <description>Number of participants achieving a complete response per International Working Group (IWG) criteria</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Higher Risk Myelodysplastic Syndromes</condition>
  <arm_group>
    <arm_group_label>evorpacept (ALX148) + azacitidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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&#xD;
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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>azacitidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Phase 2 only: Participants will receive azacitidine 75 mg/m2 IV or subcutaneous daily for 7 days of a 28-day cycle</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>evorpacept</intervention_name>
    <description>Fusion protein that blocks CD47-SIRPalpha pathway</description>
    <arm_group_label>evorpacept (ALX148) + azacitidine</arm_group_label>
    <other_name>ALX148</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>azacitidine</intervention_name>
    <description>Hypomethylating agent (HMA)</description>
    <arm_group_label>azacitidine</arm_group_label>
    <arm_group_label>evorpacept (ALX148) + azacitidine</arm_group_label>
    <other_name>Vidaza</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Phase 1: Diagnosis of higher risk MDS that is either previously untreated or&#xD;
             relapsed/refractory.&#xD;
&#xD;
          -  Phase 2: Diagnosis of higher risk MDS that is previously untreated.&#xD;
&#xD;
          -  Adequate renal and liver function.&#xD;
&#xD;
          -  Age ≥18 years.&#xD;
&#xD;
          -  Adequate performance status.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous allogeneic hematopoietic stem cell transplant (allo-HSCT) for MDS or AML.&#xD;
&#xD;
          -  Prior treatment with any anti-CD47 or anti-SIRPα (signal regulatory protein alpha)&#xD;
             agent.&#xD;
&#xD;
          -  Known active viral infections, including hepatitis B and C, human immunodeficiency&#xD;
             virus (HIV), acquired immunodeficiency syndrome (AIDS) related illness, or SARS-CoV-2&#xD;
             (severe acute respiratory syndrome coronavirus 2).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Southern California, Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University Feinberg School of Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IU Simon Cancer Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>START Midwest</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49546</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Levine Cancer Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fred Hutchinson Cancer Research Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul Saint Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Alicante</name>
      <address>
        <city>Alicante</city>
        <zip>03010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital San Pedro de Alcantara</name>
      <address>
        <city>Cáceres</city>
        <zip>10003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politecnic La Fe de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>August 11, 2023</last_update_submitted>
  <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ALX148</keyword>
  <keyword>MDS</keyword>
  <keyword>CD47</keyword>
  <keyword>Azacitidine</keyword>
  <keyword>HMA</keyword>
  <keyword>SIRP-alpha</keyword>
  <keyword>evorpacept</keyword>
  <keyword>High risk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azacitidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04417517
org study id: AT148002
nct id: NCT04417517
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
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).
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Phase 1: Dose Limiting Toxicities (DLT)
time frame: Up to 28 days
description: Number of participants with a DLT
measure: Phase 2: Complete response rate (CRR)
time frame: Approximately 6 months
description: Number of participants achieving a complete response per International Working Group (IWG) criteria
arm group label: evorpacept (ALX148) + azacitidine
arm group type: Experimental
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 group label: azacitidine
arm group type: Active Comparator
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: evorpacept
description: Fusion protein that blocks CD47-SIRPalpha pathway
arm group label: evorpacept (ALX148) + azacitidine
other name: ALX148
intervention type: Drug
intervention name: azacitidine
description: Hypomethylating agent (HMA)
arm group label: azacitidine
arm group label: evorpacept (ALX148) + azacitidine
other name: Vidaza
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Korea, Republic of
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Preleukemia
mesh term: Myelodysplastic Syndromes
mesh term: Syndrome
mesh term: Azacitidine
sharing ipd: No