<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/NCT04470726</url>
  </required_header>
  <id_info>
    <org_study_id>AIV001-C01</org_study_id>
    <nct_id>NCT04470726</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of AIV001 on Low Risk Basal Cell Carcinoma</brief_title>
  <official_title>An Exploratory Study to Evaluate the Safety and Efficacy of AIV001 Intradermally Administered in Subjects With Biopsy-confirmed Basal Cell Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AiViva BioPharma, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AiViva BioPharma, 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>
      To evaluate safety and efficacy of AIV001 treatment on low-risk basal cell carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 18, 2020</start_date>
  <completion_date type="Anticipated">June 23, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 23, 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>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>Adverse events</measure>
    <time_frame>Approximately 119 days</time_frame>
    <description>Incidence of adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clearance of basal cell carcinoma</measure>
    <time_frame>Approximately 105 days</time_frame>
    <description>Number of participants cleared of basal cell carcinoma within study duration</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Superficial Basal Cell Carcinoma</condition>
  <condition>Nodular Basal Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>AIV001 Treatment Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intradermal/intratumoral, Dose 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AIV001 Treatment Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intradermal/intratumoral, Dose 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AIV001 Treatment Dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intradermal/intratumoral, Dose 3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AIV001 Treatment Dose 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intradermal/intratumoral, Dose 4</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AIV001</intervention_name>
    <description>Intradermal/intratumoral</description>
    <arm_group_label>AIV001 Treatment Dose 1</arm_group_label>
    <arm_group_label>AIV001 Treatment Dose 2</arm_group_label>
    <arm_group_label>AIV001 Treatment Dose 3</arm_group_label>
    <arm_group_label>AIV001 Treatment Dose 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female, aged 18 to 80 years, inclusive&#xD;
&#xD;
          2. No clinically relevant abnormalities identified by a detailed medical history and&#xD;
             vital signs&#xD;
&#xD;
          3. Presence of a histologically confirmed low risk BCC lesion, with well-defined borders,&#xD;
             and with a largest diameter measure before biopsy of 5 mm to 20 mm, located on arms or&#xD;
             trunk&#xD;
&#xD;
          4. Histological diagnosis of the target lesion must have been conducted 5 to 30 days&#xD;
             prior to Day 1&#xD;
&#xD;
          5. No other dermatological disease within 50 mm of the target lesion at Day 1&#xD;
&#xD;
          6. No prior or concurrent treatment of the target lesion (including radiation therapy)&#xD;
&#xD;
          7. Willing to undergo surgical excision approximately 63 days after first treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History or presence of systemic cancer&#xD;
&#xD;
          2. Prior radiation treatment at the lesion site or anywhere else on the body within the&#xD;
             past 20 years&#xD;
&#xD;
          3. Concurrent disease or treatment that suppresses the immune system (eg, previous organ&#xD;
             transplant history, etc.)&#xD;
&#xD;
          4. Clinically relevant cardiovascular, endocrine, hepatic, neurologic, renal, or other&#xD;
             major systemic disease that could complicate execution of the protocol or&#xD;
             interpretation of the study results.&#xD;
&#xD;
          5. History of thrombotic events, hemorrhagic events, and gastrointestinal perforation and&#xD;
             fistula&#xD;
&#xD;
          6. History of recurrence or presence of any other tumor subtype in the target lesion&#xD;
&#xD;
          7. Concurrent presence of a malignant lesion within 100 mm of the target lesion that will&#xD;
             require treatment during the study&#xD;
&#xD;
          8. Current enrollment in any other investigational drug or device study within 60 days of&#xD;
             Day 1 of this study&#xD;
&#xD;
          9. Evidence of dermatological disease or confounding dermatological condition that would&#xD;
             hinder carrying out the study or interpreting the results (eg, atopic dermatitis,&#xD;
             eczema, psoriasis, xeroderma pigmentosa, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>California Dermatology &amp; Clinical Research Institute</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Island Dermatology</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Institute for Clinical Research</name>
      <address>
        <city>Pflugerville</city>
        <state>Texas</state>
        <zip>78660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nonmelanoma Skin Cancer</keyword>
  <keyword>Keratinocyte Carcinoma</keyword>
  <keyword>NMSC</keyword>
  <keyword>BCC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Basal Cell</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/NCT04470726
org study id: AIV001-C01
nct id: NCT04470726
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
To evaluate safety and efficacy of AIV001 treatment on low-risk basal cell carcinoma.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse events
time frame: Approximately 119 days
description: Incidence of adverse events
measure: Clearance of basal cell carcinoma
time frame: Approximately 105 days
description: Number of participants cleared of basal cell carcinoma within study duration
arm group label: AIV001 Treatment Dose 1
arm group type: Experimental
description: Intradermal/intratumoral, Dose 1
arm group label: AIV001 Treatment Dose 2
arm group type: Experimental
description: Intradermal/intratumoral, Dose 2
arm group label: AIV001 Treatment Dose 3
arm group type: Experimental
description: Intradermal/intratumoral, Dose 3
arm group label: AIV001 Treatment Dose 4
arm group type: Experimental
description: Intradermal/intratumoral, Dose 4
intervention type: Drug
intervention name: AIV001
description: Intradermal/intratumoral
arm group label: AIV001 Treatment Dose 1
arm group label: AIV001 Treatment Dose 2
arm group label: AIV001 Treatment Dose 3
arm group label: AIV001 Treatment Dose 4
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Basal Cell