<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/NCT03013218</url>
  </required_header>
  <id_info>
    <org_study_id>AT148001</org_study_id>
    <nct_id>NCT03013218</nct_id>
  </id_info>
  <brief_title>A Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)</brief_title>
  <official_title>A Phase 1, Dose Escalation Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)</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>No</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>
      A phase 1, dose escalation study of evorpacept (ALX148) in patients with advanced solid&#xD;
      tumors and lymphoma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This phase 1 clinical study (AT148001) is an open-label, multi-center, multiple-dose,&#xD;
      dose-escalation, safety, PK, and PD study of evorpacept (ALX148). The phase 1 protocol will&#xD;
      have 2 parts: a single agent dose escalation phase (Part 1) and a combination therapy phase&#xD;
      (Part 2). Part 2 will include an initial dose escalation portion followed by a dose expansion&#xD;
      portion. Approximately 184 adult patients are expected to be enrolled in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 3, 2017</start_date>
  <completion_date type="Anticipated">February 1, 2024</completion_date>
  <primary_completion_date type="Actual">February 1, 2022</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose-limiting toxicities (Number of participants with a DLT)</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Number of participants with a DLT</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">174</enrollment>
  <condition>Metastatic Cancer</condition>
  <condition>Solid Tumor</condition>
  <condition>Advanced Cancer</condition>
  <condition>NonHodgkin Lymphoma</condition>
  <arm_group>
    <arm_group_label>Evorpacept (ALX148)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Part 1 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Evorpacept (ALX148) + Pembrolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab infusions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Evorpacept (ALX148) + Trastuzumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab infusions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Evorpacept (ALX148) + Rituximab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with rituximab infusions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab + 5FU + platinum infusions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab + ramucirumab + paclitaxel infusions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Evorpacept (ALX148)</intervention_name>
    <description>Evorpacept (ALX148)</description>
    <arm_group_label>Evorpacept (ALX148)</arm_group_label>
    <arm_group_label>Evorpacept (ALX148) + Pembrolizumab</arm_group_label>
    <arm_group_label>Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum</arm_group_label>
    <arm_group_label>Evorpacept (ALX148) + Rituximab</arm_group_label>
    <arm_group_label>Evorpacept (ALX148) + Trastuzumab</arm_group_label>
    <arm_group_label>Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Keytruda</description>
    <arm_group_label>Evorpacept (ALX148) + Pembrolizumab</arm_group_label>
    <arm_group_label>Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trastuzumab</intervention_name>
    <description>Herceptin</description>
    <arm_group_label>Evorpacept (ALX148) + Trastuzumab</arm_group_label>
    <arm_group_label>Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>Rituxan</description>
    <arm_group_label>Evorpacept (ALX148) + Rituximab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ramucirumab + Paclitaxel</intervention_name>
    <description>Standard of care chemotherapy</description>
    <arm_group_label>Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5-FU + Cisplatin</intervention_name>
    <description>Standard of care chemotherapy</description>
    <arm_group_label>Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy;&#xD;
             or relapsed or refractory Non-Hodgkin lymphoma for whom no standard therapy is&#xD;
             available..&#xD;
&#xD;
          -  Adequate Bone Marrow Function.&#xD;
&#xD;
          -  Adequate Renal &amp; Liver Function.&#xD;
&#xD;
          -  Adequate Performance Status&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known symptomatic CNS metastases or lepotomeningeal disease requiring&#xD;
             steroids.&#xD;
&#xD;
          -  Previous high-dose chemotherapy requiring allogenic stem cell rescue.&#xD;
&#xD;
          -  Prior treatment with a CD47 or signal regulatory protein (SIRP) alpha targeting agent.&#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 Colorado Denver</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>START-Midwest</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</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>Severance Hospital, Yonsei University</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</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>Neoplasms</keyword>
  <keyword>CD47</keyword>
  <keyword>SIRPα</keyword>
  <keyword>ALX148</keyword>
  <keyword>Evorpacept</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Rituximab</mesh_term>
    <mesh_term>Pembrolizumab</mesh_term>
    <mesh_term>Trastuzumab</mesh_term>
    <mesh_term>Ramucirumab</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/NCT03013218
org study id: AT148001
nct id: NCT03013218
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A phase 1, dose escalation study of evorpacept (ALX148) in patients with advanced solid
      tumors and lymphoma
This phase 1 clinical study (AT148001) is an open-label, multi-center, multiple-dose,
      dose-escalation, safety, PK, and PD study of evorpacept (ALX148). The phase 1 protocol will
      have 2 parts: a single agent dose escalation phase (Part 1) and a combination therapy phase
      (Part 2). Part 2 will include an initial dose escalation portion followed by a dose expansion
      portion. Approximately 184 adult patients are expected to be enrolled in the study.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose-limiting toxicities (Number of participants with a DLT)
time frame: Up to 28 days
description: Number of participants with a DLT
arm group label: Evorpacept (ALX148)
arm group type: Experimental
description: The Part 1 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks.
arm group label: Evorpacept (ALX148) + Pembrolizumab
arm group type: Experimental
description: The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab infusions.
arm group label: Evorpacept (ALX148) + Trastuzumab
arm group type: Experimental
description: The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab infusions.
arm group label: Evorpacept (ALX148) + Rituximab
arm group type: Experimental
description: The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with rituximab infusions.
arm group label: Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum
arm group type: Experimental
description: The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab + 5FU + platinum infusions.
arm group label: Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel
arm group type: Experimental
description: The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab + ramucirumab + paclitaxel infusions.
intervention type: Drug
intervention name: Evorpacept (ALX148)
description: Evorpacept (ALX148)
arm group label: Evorpacept (ALX148)
arm group label: Evorpacept (ALX148) + Pembrolizumab
arm group label: Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum
arm group label: Evorpacept (ALX148) + Rituximab
arm group label: Evorpacept (ALX148) + Trastuzumab
arm group label: Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel
intervention type: Drug
intervention name: Pembrolizumab
description: Keytruda
arm group label: Evorpacept (ALX148) + Pembrolizumab
arm group label: Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum
intervention type: Drug
intervention name: Trastuzumab
description: Herceptin
arm group label: Evorpacept (ALX148) + Trastuzumab
arm group label: Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel
intervention type: Drug
intervention name: Rituximab
description: Rituxan
arm group label: Evorpacept (ALX148) + Rituximab
intervention type: Drug
intervention name: Ramucirumab + Paclitaxel
description: Standard of care chemotherapy
arm group label: Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel
intervention type: Drug
intervention name: 5-FU + Cisplatin
description: Standard of care chemotherapy
arm group label: Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Paclitaxel
mesh term: Rituximab
mesh term: Pembrolizumab
mesh term: Trastuzumab
mesh term: Ramucirumab
sharing ipd: No