<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/NCT04417530</url>
  </required_header>
  <id_info>
    <org_study_id>AU-011-202</org_study_id>
    <nct_id>NCT04417530</nct_id>
  </id_info>
  <brief_title>Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma</brief_title>
  <official_title>A Phase 2 Open-label, Ascending Single and Repeat Dose Escalation Trial of Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aura Biosciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aura Biosciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to determine the safety, tolerability, and preliminary efficacy of&#xD;
      belzupacap sarotalocan for the treatment of primary indeterminate lesions and small choroidal&#xD;
      melanoma (IL/CM).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, ascending single and repeat dose escalation trial designed to evaluate&#xD;
      the safety, tolerability, and preliminary efficacy of up to 4 dose levels and repeat dose&#xD;
      regimens of belzupacap sarotalocan via suprachoroidal administration with 1 or 2 laser&#xD;
      applications per treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 5, 2020</start_date>
  <completion_date type="Anticipated">May 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment related AEs and treatment related serious adverse events (SAEs).</measure>
    <time_frame>52 weeks</time_frame>
    <description>Adverse Events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks.</measure>
    <time_frame>52 weeks</time_frame>
    <description>Tumor Thickness Growth Rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach tumor progression</measure>
    <time_frame>52 weeks</time_frame>
    <description>Tumor progression</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Uveal Melanoma</condition>
  <condition>Ocular Melanoma</condition>
  <condition>Choroidal Melanoma</condition>
  <arm_group>
    <arm_group_label>Cohort 1 AU-011 &amp; Laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low dose of AU-011 + 1 laser application</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 AU-011 &amp; Laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Medium dose of AU-011 + 1 laser application</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3 AU-011 &amp; Laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Medium dose of AU-011 + 2 laser applications</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4 AU-011 &amp; Laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Highest tolerated dose of AU-011/laser applications from Cohorts 1 to 3 administered weekly for 2 treatments</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 5 AU-011 &amp; Laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AU-011/laser applications from Cohorts 1 to 3 administered weekly for 3 treatments. Up to 2 cycles of this regimen may be administered and subjects have the option of receiving a third cycle of treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 6 AU-011 &amp; Laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AU-011</intervention_name>
    <description>AU-011 Via Suprachoroidal Administration with laser treatment</description>
    <arm_group_label>Cohort 1 AU-011 &amp; Laser</arm_group_label>
    <arm_group_label>Cohort 2 AU-011 &amp; Laser</arm_group_label>
    <arm_group_label>Cohort 3 AU-011 &amp; Laser</arm_group_label>
    <arm_group_label>Cohort 4 AU-011 &amp; Laser</arm_group_label>
    <arm_group_label>Cohort 5 AU-011 &amp; Laser</arm_group_label>
    <arm_group_label>Cohort 6 AU-011 &amp; Laser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Suprachoroidal Microinjector</intervention_name>
    <description>Suprachoroidal Injection Device</description>
    <arm_group_label>Cohort 1 AU-011 &amp; Laser</arm_group_label>
    <arm_group_label>Cohort 2 AU-011 &amp; Laser</arm_group_label>
    <arm_group_label>Cohort 3 AU-011 &amp; Laser</arm_group_label>
    <arm_group_label>Cohort 4 AU-011 &amp; Laser</arm_group_label>
    <arm_group_label>Cohort 5 AU-011 &amp; Laser</arm_group_label>
    <arm_group_label>Cohort 6 AU-011 &amp; Laser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PDT Laser</intervention_name>
    <description>Laser Administration</description>
    <arm_group_label>Cohort 1 AU-011 &amp; Laser</arm_group_label>
    <arm_group_label>Cohort 2 AU-011 &amp; Laser</arm_group_label>
    <arm_group_label>Cohort 3 AU-011 &amp; Laser</arm_group_label>
    <arm_group_label>Cohort 4 AU-011 &amp; Laser</arm_group_label>
    <arm_group_label>Cohort 5 AU-011 &amp; Laser</arm_group_label>
    <arm_group_label>Cohort 6 AU-011 &amp; Laser</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)&#xD;
&#xD;
          -  Have no evidence of metastatic disease confirmed by imaging&#xD;
&#xD;
          -  Be treatment naïve for IL/CM&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have known contraindications or sensitivities to the study drug or laser&#xD;
&#xD;
          -  Active ocular 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_official>
    <last_name>Medical Monitor</last_name>
    <role>Study Director</role>
    <affiliation>Aura Biosciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Retina Associates SW, P.C.</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Jules Stein Eye Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Byers Eye Institute at Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCHealth Eye Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Associates of Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory Eye Center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Illinois At Chicago Illinois Eye and Ear Infirmary</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Eye Institute</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46290</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Department of Ophthalmology and Visual Sciences</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts Eye and Ear Infirmary</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>W. K. Kellogg Eye Center, University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associated Retinal Consultants, PC</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dean McGee Eye Institute</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University Casey Eye Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wills Eye Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Carolina, PA</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Thomas Health / Tennessee Retina, PC</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Retina Associates</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Dept of Ophthalmology &amp; Visual Sciences</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.aurabiosciences.com/</url>
    <description>Aura Biosciences</description>
  </link>
  <verification_date>June 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>June 21, 2023</last_update_submitted>
  <last_update_submitted_qc>June 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Uveal Melanoma</keyword>
  <keyword>Eye Cancer</keyword>
  <keyword>Ocular Melanoma</keyword>
  <keyword>Choroidal Melanoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
  </condition_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/NCT04417530
org study id: AU-011-202
nct id: NCT04417530
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
is unapproved device: Yes
The primary objective is to determine the safety, tolerability, and preliminary efficacy of
      belzupacap sarotalocan for the treatment of primary indeterminate lesions and small choroidal
      melanoma (IL/CM).
This is an open-label, ascending single and repeat dose escalation trial designed to evaluate
      the safety, tolerability, and preliminary efficacy of up to 4 dose levels and repeat dose
      regimens of belzupacap sarotalocan via suprachoroidal administration with 1 or 2 laser
      applications per treatment.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Treatment related AEs and treatment related serious adverse events (SAEs).
time frame: 52 weeks
description: Adverse Events
measure: Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks.
time frame: 52 weeks
description: Tumor Thickness Growth Rate
measure: Time to reach tumor progression
time frame: 52 weeks
description: Tumor progression
arm group label: Cohort 1 AU-011 & Laser
arm group type: Experimental
description: Low dose of AU-011 + 1 laser application
arm group label: Cohort 2 AU-011 & Laser
arm group type: Experimental
description: Medium dose of AU-011 + 1 laser application
arm group label: Cohort 3 AU-011 & Laser
arm group type: Experimental
description: Medium dose of AU-011 + 2 laser applications
arm group label: Cohort 4 AU-011 & Laser
arm group type: Experimental
description: Highest tolerated dose of AU-011/laser applications from Cohorts 1 to 3 administered weekly for 2 treatments
arm group label: Cohort 5 AU-011 & Laser
arm group type: Experimental
description: AU-011/laser applications from Cohorts 1 to 3 administered weekly for 3 treatments. Up to 2 cycles of this regimen may be administered and subjects have the option of receiving a third cycle of treatment.
arm group label: Cohort 6 AU-011 & Laser
arm group type: Experimental
description: High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment.
intervention type: Drug
intervention name: AU-011
description: AU-011 Via Suprachoroidal Administration with laser treatment
arm group label: Cohort 1 AU-011 & Laser
arm group label: Cohort 2 AU-011 & Laser
arm group label: Cohort 3 AU-011 & Laser
arm group label: Cohort 4 AU-011 & Laser
arm group label: Cohort 5 AU-011 & Laser
arm group label: Cohort 6 AU-011 & Laser
intervention type: Device
intervention name: Suprachoroidal Microinjector
description: Suprachoroidal Injection Device
arm group label: Cohort 1 AU-011 & Laser
arm group label: Cohort 2 AU-011 & Laser
arm group label: Cohort 3 AU-011 & Laser
arm group label: Cohort 4 AU-011 & Laser
arm group label: Cohort 5 AU-011 & Laser
arm group label: Cohort 6 AU-011 & Laser
intervention type: Device
intervention name: PDT Laser
description: Laser Administration
arm group label: Cohort 1 AU-011 & Laser
arm group label: Cohort 2 AU-011 & Laser
arm group label: Cohort 3 AU-011 & Laser
arm group label: Cohort 4 AU-011 & Laser
arm group label: Cohort 5 AU-011 & Laser
arm group label: Cohort 6 AU-011 & Laser
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Monitor
role: Study Director
affiliation: Aura Biosciences
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country: United States
url: http://www.aurabiosciences.com/
description: Aura Biosciences
responsible party type: Sponsor
mesh term: Melanoma
sharing ipd: No