<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/NCT04452955</url>
  </required_header>
  <id_info>
    <org_study_id>226688</org_study_id>
    <nct_id>NCT04452955</nct_id>
  </id_info>
  <brief_title>A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients With Solid Tumors</brief_title>
  <official_title>An Open Label, Multicenter, Safety and Efficacy Phase 2 Study of PRL3-Zumab in Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intra-IMMUSG Pte Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Parexel</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Intra-IMMUSG Pte Ltd</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>
      This is a multi-center, Phase 2, open-label, single dose level study of PRL3-zumab&#xD;
      monotherapy in patients with unresectable or metastatic solid tumor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study consists of a Screening Period (Day - 14 to Day -1), a Treatment Period during&#xD;
      which visits will occur every 2 weeks, an End of Treatment visit within 14 days of the&#xD;
      decision to discontinue treatment for any reason, and a Safety Follow-up visit at 14 ± 4 days&#xD;
      after the last dose of study treatment. PRL3-zumab will be administered by intravenous (IV)&#xD;
      infusion till patient meets any of the discontinuation criteria (progressive disease,&#xD;
      clinically or per RECIST v1.1 and iRECIST, intolerable toxicity or withdrawal of consent).&#xD;
      One cycle of treatment will be 4 weeks (2 infusions, 12 days ±2 days apart).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 12, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression free survival (PFS)</measure>
    <time_frame>From first dose of study drug until disease progression or end of treatment, whichever comes first</time_frame>
    <description>PFS is defined as the time from the initiation of study treatment to the date of disease progression as per RECIST v1.1 and iRECIST criteria.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>From first dose of study drug until disease progression or end of treatment, whichever comes first</time_frame>
    <description>ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) as per RECIST v1.1 and iRECIST criteria from time of initiation of study treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical benefit rate (CBR)</measure>
    <time_frame>From first dose of study drug until disease progression or end of treatment, whichever comes first</time_frame>
    <description>CBR is defined as the percentage of patients with CR, PR, or stable disease (SD) as per RECIST v1.1 and iRECIST criteria based on Investigator's assessment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>From first dose of study drug until disease progression or end of treatment, whichever comes first</time_frame>
    <description>OS is defined as the time from the initiation of study treatment to death from any cause.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of response</measure>
    <time_frame>From first dose of study drug until disease progression or end of treatment, whichever comes first</time_frame>
    <description>Duration of response is defined as the time from the initial documented response (CR or PR) to the first documented sign of disease progression as per RECIST v1.1 and iRECIST criteria or death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma PRL3-zumab concentration (Cmax)</measure>
    <time_frame>Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day.</time_frame>
    <description>To assess pharmacokinetics (PK) after single and multiple dose administration of PRL3-zumab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Cmax (tmax)</measure>
    <time_frame>Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day.</time_frame>
    <description>To assess PK after single and multiple dose administration of PRL3-zumab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration time curve from pre-dose (AUCinf)</measure>
    <time_frame>Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day.</time_frame>
    <description>To assess PK after single and multiple dose administration of PRL3-zumab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal elimination half life (t½)</measure>
    <time_frame>Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day.</time_frame>
    <description>To assess PK after single and multiple dose administration of PRL3-zumab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events and serious adverse events</measure>
    <time_frame>From first dose of study drug until disease progression or end of treatment, whichever comes first</time_frame>
    <description>To assess safety of PRL3-zumab in patients with unresectable or metastatic solid tumors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Quality-5D (EQ-5D)</measure>
    <time_frame>From first dose of study drug until disease progression or end of treatment, whichever comes first</time_frame>
    <description>The system comprises 5 questions, 1 for each of 5 domains: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each is rated according to 3 response levels (&quot;no problems,&quot; &quot;some problems,&quot; or &quot;extreme problems&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Organization for Research and Treatment of Cancer-quality of life quantionnaire-C30 (EORTC-QLQ-C30)</measure>
    <time_frame>From first dose of study drug until disease progression or end of treatment, whichever comes first</time_frame>
    <description>Health-related quality of life is measured by EORTC-QLQ-C30, a 30 item questionnaire. This scale consists of functioning scales and symptom scales. For functioning scales higher scores suggest better functioning; for symptom scales higher scores suggest higher symptom burden.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eastern Cooperative Oncology Group Performance Status (ECOG PS)</measure>
    <time_frame>From first dose of study drug until disease progression or end of treatment, whichever comes first</time_frame>
    <description>To assess safety of PRL3-zumab in patients with unresectable or metastatic solid tumors.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">55</enrollment>
  <condition>Solid Tumor</condition>
  <arm_group>
    <arm_group_label>PRL3-zumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will receive PRL3-zumab until clinical progression per RECIST v1.1 and iRECIST criteria, or unacceptable toxicity, or withdraws consent.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PRL3-zumab</intervention_name>
    <description>Starting dose of 6 mg/kg will be administered as IV infusion over 60 minutes every 2 weeks (±2 days)</description>
    <arm_group_label>PRL3-zumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with unresectable or metastatic solid tumors willing to provide signed&#xD;
             informed consent.&#xD;
&#xD;
          -  Histopathological diagnosis and metastatic status cancer at study entry.&#xD;
&#xD;
          -  Must have received at least 1 prior line of systemic therapy for metastatic disease&#xD;
             but no more than 3 prior lines of treatment for metastatic disease.&#xD;
&#xD;
          -  Life expectancy of more than 6 months.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) score or less than&#xD;
             2.&#xD;
&#xD;
          -  Adequate organ and hematological function.&#xD;
&#xD;
          -  Measurable disease by RECIST v1.1 and iRECIST.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has known untreated or symptomatic central nervous system metastasis.&#xD;
&#xD;
          -  Patient is receiving systemic glucocorticoids or other immunosuppressive treatments&#xD;
             for autoimmune disease or any other medical condition.&#xD;
&#xD;
          -  Patient has experienced a severe hypersensitivity reaction to another monoclonal&#xD;
             antibody.&#xD;
&#xD;
          -  Patient has received treatment with any systemic anti-cancer therapies within 3 weeks&#xD;
             prior to starting study treatment.&#xD;
&#xD;
          -  Patient has undergone radiotherapy ≤ 4 weeks prior to starting study treatment.&#xD;
&#xD;
          -  Patient has received &gt; 3 lines of prior systemic chemotherapy for metastatic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rio Aquino</last_name>
    <phone>+1 562 359-9666</phone>
    <email>Rio.Aquino@PAREXEL.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Qi Zeng</last_name>
    <email>mcbzengq@imcb.a-star.edu.sg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>HonorHealth Research</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Irfan Uddin</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>St. Jude Medical Center</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Blanca Sanchez</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Angeles Clinic</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roland Menendez</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Norton Healthcare</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40200</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kylee Fleig</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89014</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karishma Gupta</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PRL-3</keyword>
  <keyword>Tumor</keyword>
  <keyword>Efficacy</keyword>
  <keyword>Safety</keyword>
  <keyword>Pharmacokinetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT04452955
org study id: 226688
nct id: NCT04452955
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a multi-center, Phase 2, open-label, single dose level study of PRL3-zumab
      monotherapy in patients with unresectable or metastatic solid tumor.
The study consists of a Screening Period (Day - 14 to Day -1), a Treatment Period during
      which visits will occur every 2 weeks, an End of Treatment visit within 14 days of the
      decision to discontinue treatment for any reason, and a Safety Follow-up visit at 14 ± 4 days
      after the last dose of study treatment. PRL3-zumab will be administered by intravenous (IV)
      infusion till patient meets any of the discontinuation criteria (progressive disease,
      clinically or per RECIST v1.1 and iRECIST, intolerable toxicity or withdrawal of consent).
      One cycle of treatment will be 4 weeks (2 infusions, 12 days ±2 days apart).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression free survival (PFS)
time frame: From first dose of study drug until disease progression or end of treatment, whichever comes first
description: PFS is defined as the time from the initiation of study treatment to the date of disease progression as per RECIST v1.1 and iRECIST criteria.
measure: Objective response rate (ORR)
time frame: From first dose of study drug until disease progression or end of treatment, whichever comes first
description: ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) as per RECIST v1.1 and iRECIST criteria from time of initiation of study treatment.
measure: Clinical benefit rate (CBR)
time frame: From first dose of study drug until disease progression or end of treatment, whichever comes first
description: CBR is defined as the percentage of patients with CR, PR, or stable disease (SD) as per RECIST v1.1 and iRECIST criteria based on Investigator's assessment.
measure: Overall survival (OS)
time frame: From first dose of study drug until disease progression or end of treatment, whichever comes first
description: OS is defined as the time from the initiation of study treatment to death from any cause.
measure: Duration of response
time frame: From first dose of study drug until disease progression or end of treatment, whichever comes first
description: Duration of response is defined as the time from the initial documented response (CR or PR) to the first documented sign of disease progression as per RECIST v1.1 and iRECIST criteria or death.
measure: Maximum plasma PRL3-zumab concentration (Cmax)
time frame: Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day.
description: To assess pharmacokinetics (PK) after single and multiple dose administration of PRL3-zumab.
measure: Time of Cmax (tmax)
time frame: Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day.
description: To assess PK after single and multiple dose administration of PRL3-zumab.
measure: Area under the concentration time curve from pre-dose (AUCinf)
time frame: Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day.
description: To assess PK after single and multiple dose administration of PRL3-zumab.
measure: Terminal elimination half life (t½)
time frame: Pre-dose and during first dose of C1, pre dose C1D15, C2D1, C2D15, C3D1, and pre dose and during the second dose of C3, pre-dose C4D1, C5D1, C6D1 and at end of treatment (up to approximately 6 months). Duration of 1 cycle is 4 weeks. C = Cycle, D = Day.
description: To assess PK after single and multiple dose administration of PRL3-zumab.
measure: Number of patients with adverse events and serious adverse events
time frame: From first dose of study drug until disease progression or end of treatment, whichever comes first
description: To assess safety of PRL3-zumab in patients with unresectable or metastatic solid tumors.
measure: European Quality-5D (EQ-5D)
time frame: From first dose of study drug until disease progression or end of treatment, whichever comes first
description: The system comprises 5 questions, 1 for each of 5 domains: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each is rated according to 3 response levels ("no problems," "some problems," or "extreme problems").
measure: European Organization for Research and Treatment of Cancer-quality of life quantionnaire-C30 (EORTC-QLQ-C30)
time frame: From first dose of study drug until disease progression or end of treatment, whichever comes first
description: Health-related quality of life is measured by EORTC-QLQ-C30, a 30 item questionnaire. This scale consists of functioning scales and symptom scales. For functioning scales higher scores suggest better functioning; for symptom scales higher scores suggest higher symptom burden.
measure: Eastern Cooperative Oncology Group Performance Status (ECOG PS)
time frame: From first dose of study drug until disease progression or end of treatment, whichever comes first
description: To assess safety of PRL3-zumab in patients with unresectable or metastatic solid tumors.
arm group label: PRL3-zumab
arm group type: Experimental
description: All patients will receive PRL3-zumab until clinical progression per RECIST v1.1 and iRECIST criteria, or unacceptable toxicity, or withdraws consent.
intervention type: Biological
intervention name: PRL3-zumab
description: Starting dose of 6 mg/kg will be administered as IV infusion over 60 minutes every 2 weeks (±2 days)
arm group label: PRL3-zumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rio Aquino
phone: +1 562 359-9666
email: Rio.Aquino@PAREXEL.com
last name: Qi Zeng
email: mcbzengq@imcb.a-star.edu.sg
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms