<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/NCT03013491</url>
  </required_header>
  <id_info>
    <org_study_id>CTMX-M-072-001</org_study_id>
    <nct_id>NCT03013491</nct_id>
  </id_info>
  <brief_title>PROCLAIM-CX-072: A Trial to Find Safe and Active Doses of an Investigational Drug CX-072 for Patients With Solid Tumors or Lymphomas</brief_title>
  <official_title>An Open-Label, Dose-Finding and Proof of Concept Study of the PD-L1 Probody™ Therapeutic , CX-072, as Monotherapy and in Combination With Yervoy (Ipilimumab) or With Zelboraf (Vemurafenib) in Subjects With Advanced or Recurrent Solid Tumors or Lymphomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CytomX Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CytomX Therapeutics</source>
  <brief_summary>
    <textblock>
      The purpose of this first-in-human study of CX-072 is to characterize the safety,&#xD;
      tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-072&#xD;
      administered intravenously (IV) as a single agent or in combination with ipilimumab or&#xD;
      vemurafenib in adult subjects with advanced or recurrent solid tumors or lymphomas.&#xD;
      PROCLAIM-CX-072: PRObody CLinical Assessment In Man CX-072 clinical trial&#xD;
&#xD;
      CX-072 is a Probody™ therapeutic directed against PD-L1 (programmed cell death ligand 1).&#xD;
      Probody therapeutics are proteolytically-activatable antibodies (Abs) designed to widen the&#xD;
      therapeutic index by minimizing drug interaction with normal tissue while retaining&#xD;
      anti-tumor activity. Probody therapeutics are &quot;masked&quot; to attenuate binding to target in&#xD;
      healthy tissue but can become &quot;unmasked&quot; in the tumor microenvironment by tumor-specific&#xD;
      protease activity.&#xD;
&#xD;
      PROBODY is a trademark of CytomX Therapeutics, Inc.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">October 6, 2021</completion_date>
  <primary_completion_date type="Actual">October 6, 2021</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>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of subjects experiencing a dose limiting toxicity at various dose levels when given multiple doses of CX-072 as a monotherapy or in combination with ipilimumab or vemurafenib</measure>
    <time_frame>28 days (dose limiting toxicity period)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given multiple doses of CX-072 as a monotherapy or in combination with ipilimumab or vemurafenib</measure>
    <time_frame>2 Years</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Solid Tumor</condition>
  <condition>Lymphoma</condition>
  <arm_group>
    <arm_group_label>CX-072</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Monotherapy CX-072</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CX-072 with Ipilimumab #1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combination CX-072 + ipilimumab (Schedule 1)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CX-072 with Ipilimumab #2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combination CX-072 + ipilimumab (Schedule 2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CX-072 with Vemurafenib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combination CX-072 + vemurafenib</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CX-072 expansion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Monotherapy CX-072</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CX-072</intervention_name>
    <arm_group_label>CX-072</arm_group_label>
    <arm_group_label>CX-072 expansion</arm_group_label>
    <arm_group_label>CX-072 with Ipilimumab #1</arm_group_label>
    <arm_group_label>CX-072 with Ipilimumab #2</arm_group_label>
    <arm_group_label>CX-072 with Vemurafenib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ipilimumab</intervention_name>
    <arm_group_label>CX-072 with Ipilimumab #1</arm_group_label>
    <arm_group_label>CX-072 with Ipilimumab #2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>vemurafenib</intervention_name>
    <arm_group_label>CX-072 with Vemurafenib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed diagnosis of metastatic or advanced unresectable tumors that&#xD;
             progressed on standard therapy&#xD;
&#xD;
          2. Agreement to provide mandatory archival tissue or fresh biopsy.&#xD;
&#xD;
          3. At least 18 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.&#xD;
&#xD;
          2. History of severe allergic or anaphylactic reactions to human monoclonal antibody&#xD;
             therapy or known hypersensitivity to any Probody therapeutic.&#xD;
&#xD;
          3. Active or history of uveal, mucosal, or ocular melanoma. Human immunodeficiency virus&#xD;
             (HIV) or acquired immune deficiency syndrome (AIDS)-related illness, chronic hepatitis&#xD;
             B or C.&#xD;
&#xD;
          4. History of or current active autoimmune diseases, including but not limited to&#xD;
             inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune&#xD;
             hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis,&#xD;
             autoimmune neuropathies, or type 1 insulin dependent diabetes mellitus.&#xD;
&#xD;
          5. History of syndrome or medical condition(s) that requires systemic steroids (&gt; 10 mg&#xD;
             daily prednisone equivalents) or immunosuppressive medications.&#xD;
&#xD;
          6. History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow&#xD;
             transplant.&#xD;
&#xD;
          7. Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational&#xD;
             treatment within 30 days prior to receiving any study drug.&#xD;
&#xD;
          8. Major surgery (requiring general anesthesia) within 3 months or minor surgery&#xD;
             (excluding biopsies conducted with local/topical anesthesia) or gamma knife treatment&#xD;
             within 14 days (with adequate healing) of administration of any study drug.&#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_official>
    <last_name>Lawrence Lu, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>CytomX Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53579</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Amsterdam</city>
        <zip>1007</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Groningen</city>
        <zip>9713 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Rotterdam</city>
        <zip>3000 CA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Katowice</city>
        <zip>40-960</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Pamplona</city>
        <state>Navarre</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08908</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Barcelona</city>
        <zip>8036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Ssite</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Dnepropetrovsk</city>
        <zip>49102</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Invetigative Site</name>
      <address>
        <city>Glasgow</city>
        <zip>G12 0YN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>London</city>
        <zip>W1G 6AD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PROCLAIM Investigative Site</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Hungary</country>
  </removed_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>December 26, 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>February 7, 2022</last_update_submitted>
  <last_update_submitted_qc>February 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cancer</keyword>
  <keyword>checkpoint inhibitor</keyword>
  <keyword>monotherapy</keyword>
  <keyword>combination</keyword>
  <keyword>PD-L1</keyword>
  <keyword>CTLA-4</keyword>
  <keyword>solid tumor</keyword>
  <keyword>lymphoma</keyword>
  <keyword>BRAF</keyword>
  <keyword>PROCLAIM</keyword>
  <keyword>CX-072</keyword>
  <keyword>PROCLAIM-CX-072</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ipilimumab</mesh_term>
    <mesh_term>Vemurafenib</mesh_term>
  </intervention_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/NCT03013491
org study id: CTMX-M-072-001
nct id: NCT03013491
lead sponsor: 
The purpose of this first-in-human study of CX-072 is to characterize the safety,
      tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-072
      administered intravenously (IV) as a single agent or in combination with ipilimumab or
      vemurafenib in adult subjects with advanced or recurrent solid tumors or lymphomas.
      PROCLAIM-CX-072: PRObody CLinical Assessment In Man CX-072 clinical trial

      CX-072 is a Probody™ therapeutic directed against PD-L1 (programmed cell death ligand 1).
      Probody therapeutics are proteolytically-activatable antibodies (Abs) designed to widen the
      therapeutic index by minimizing drug interaction with normal tissue while retaining
      anti-tumor activity. Probody therapeutics are "masked" to attenuate binding to target in
      healthy tissue but can become "unmasked" in the tumor microenvironment by tumor-specific
      protease activity.

      PROBODY is a trademark of CytomX Therapeutics, Inc.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The number of subjects experiencing a dose limiting toxicity at various dose levels when given multiple doses of CX-072 as a monotherapy or in combination with ipilimumab or vemurafenib
time frame: 28 days (dose limiting toxicity period)
measure: The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given multiple doses of CX-072 as a monotherapy or in combination with ipilimumab or vemurafenib
time frame: 2 Years
arm group label: CX-072
arm group type: Experimental
description: Monotherapy CX-072
arm group label: CX-072 with Ipilimumab #1
arm group type: Experimental
description: Combination CX-072 + ipilimumab (Schedule 1)
arm group label: CX-072 with Ipilimumab #2
arm group type: Experimental
description: Combination CX-072 + ipilimumab (Schedule 2)
arm group label: CX-072 with Vemurafenib
arm group type: Experimental
description: Combination CX-072 + vemurafenib
arm group label: CX-072 expansion
arm group type: Experimental
description: Monotherapy CX-072
intervention type: Drug
intervention name: CX-072
arm group label: CX-072
arm group label: CX-072 expansion
arm group label: CX-072 with Ipilimumab #1
arm group label: CX-072 with Ipilimumab #2
arm group label: CX-072 with Vemurafenib
intervention type: Drug
intervention name: ipilimumab
arm group label: CX-072 with Ipilimumab #1
arm group label: CX-072 with Ipilimumab #2
intervention type: Drug
intervention name: vemurafenib
arm group label: CX-072 with Vemurafenib
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lawrence Lu, M.D.
role: Study Director
affiliation: CytomX Therapeutics
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country: Netherlands
country: Poland
country: Spain
country: Ukraine
country: United Kingdom
country: United States
country: Hungary
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Ipilimumab
mesh term: Vemurafenib