xml: <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/NCT05970497</url>
    </required_header>
    <id_info>
      <org_study_id>KB707-01</org_study_id>
      <nct_id>NCT05970497</nct_id>
    </id_info>
    <brief_title>A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors</brief_title>
    <official_title>A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study of KB707 in Subjects With Locally Advanced or Metastatic Solid Tumor Malignancies</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Krystal Biotech, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Krystal Biotech, 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>
        KB707-01 is a Phase 1, open-label, multicenter, dose escalation and expansion study to&#xD;
        evaluate the safety and tolerability of KB707 in adults with locally advanced or metastatic&#xD;
        solid tumors who have progressed on standard of care therapy, cannot tolerate standard of&#xD;
        care therapy, refused standard of care therapy, or for whom there is no standard of care&#xD;
        therapy. In this study, patients will receive KB707 via direct intratumoral (IT) injection&#xD;
        into solid tumors to assess the safety and tolerability as well preliminary efficacy of KB707&#xD;
        monotherapy treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        KB707 is a genetically modified herpes simplex type 1 virus that is designed to stimulate an&#xD;
        anti-tumor immune response through the production of cytokines. This is a first-in-human&#xD;
        (FIH) clinical study to evaluate the safety and tolerability, biodistribution, shedding, and&#xD;
        preliminary efficacy of KB707 in adult subjects with advanced and/or refractory solid tumors.&#xD;
        The study will include a dose escalation portion for single agent KB707 and an expansion&#xD;
        portion to further evaluate single agent KB707 at a dose determined by preliminary data in&#xD;
        the dose escalation phase.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 2023</start_date>
    <completion_date type="Anticipated">July 2026</completion_date>
    <primary_completion_date type="Anticipated">July 2026</primary_completion_date>
    <phase>Early Phase 1</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>Percentage of adverse events (AEs)</measure>
      <time_frame>up to 36 months</time_frame>
      <description>Percentage of subjects with adverse events (AEs)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of serious adverse events (SAEs)</measure>
      <time_frame>up to 36 months</time_frame>
      <description>Percentage of subjects with serious adverse events (SAEs)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maximum tolerated dose (MTD)</measure>
      <time_frame>up to 36 months</time_frame>
      <description>Assess whether the tested doses include the maximum tolerated dose (MTD) of KB707 based on the safety and response data collected during the dose escalation portion of the study</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of overall response rate (ORR)</measure>
      <time_frame>up to 36 months</time_frame>
      <description>Percentage of ORR</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Cancer</condition>
    <condition>Melanoma Stage III</condition>
    <condition>Melanoma Stage IV</condition>
    <condition>Cutaneous Melanoma</condition>
    <condition>Osteosarcoma</condition>
    <condition>Carcinoma, Squamous Cell</condition>
    <condition>Carcinoma, Basal Cell</condition>
    <arm_group>
      <arm_group_label>Dose escalation of KB707 by intratumoral (IT) injection in solid tumors</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dose escalation of single-agent KB707 in 3 cohorts by IT injection</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dose expansion of KB707 by IT injection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dose escalation of single-agent KB707 in superficial and deep/visceral solid tumors</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>KB707</intervention_name>
      <description>Genetically modified herpes simplex type 1 virus</description>
      <arm_group_label>Dose escalation of KB707 by intratumoral (IT) injection in solid tumors</arm_group_label>
      <arm_group_label>Dose expansion of KB707 by IT injection</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            -  Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor and&#xD;
               the individual has progressed on standard of care therapy, cannot tolerate standard of&#xD;
               care therapy, refused standard of care therapy, or there is no standard of care&#xD;
               therapy.&#xD;
  &#xD;
            -  Age 18 years or older at the time of informed consent&#xD;
  &#xD;
            -  Life expectancy &gt;12 weeks&#xD;
  &#xD;
            -  ECOG performance status of 0 or 1&#xD;
  &#xD;
            -  Have at least one measurable and injectable tumor that is accessible by transcutaneous&#xD;
               administration&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            -  Prior oncology therapy (chemotherapy, immunotherapy, biological therapy) or use of an&#xD;
               investigational agent or an investigational device within 21 days or 5 half-lives&#xD;
               before administration of first dose of KB707, whichever is shorter&#xD;
  &#xD;
            -  The subject is pregnant, nursing, or plans to become pregnant during study treatment&#xD;
               and through three months after the last dose of KB707&#xD;
  &#xD;
            -  Have known history of positive human immunodeficiency virus (HIV 1/2)&#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>David Chien, MD</last_name>
      <role>Study Director</role>
      <affiliation>Senior Vice President of Clinical Development</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Brittani Agostini, RN, CCRC</last_name>
      <phone>412-586-5830</phone>
      <email>bagostini@krystalbio.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Melanoma</mesh_term>
      <mesh_term>Osteosarcoma</mesh_term>
      <mesh_term>Carcinoma, Squamous Cell</mesh_term>
      <mesh_term>Carcinoma, Basal Cell</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970497
  org study id: KB707-01
  nct id: NCT05970497
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  KB707-01 is a Phase 1, open-label, multicenter, dose escalation and expansion study to
        evaluate the safety and tolerability of KB707 in adults with locally advanced or metastatic
        solid tumors who have progressed on standard of care therapy, cannot tolerate standard of
        care therapy, refused standard of care therapy, or for whom there is no standard of care
        therapy. In this study, patients will receive KB707 via direct intratumoral (IT) injection
        into solid tumors to assess the safety and tolerability as well preliminary efficacy of KB707
        monotherapy treatment.
  KB707 is a genetically modified herpes simplex type 1 virus that is designed to stimulate an
        anti-tumor immune response through the production of cytokines. This is a first-in-human
        (FIH) clinical study to evaluate the safety and tolerability, biodistribution, shedding, and
        preliminary efficacy of KB707 in adult subjects with advanced and/or refractory solid tumors.
        The study will include a dose escalation portion for single agent KB707 and an expansion
        portion to further evaluate single agent KB707 at a dose determined by preliminary data in
        the dose escalation phase.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Percentage of adverse events (AEs)
  time frame: up to 36 months
  description: Percentage of subjects with adverse events (AEs)
  measure: Percentage of serious adverse events (SAEs)
  time frame: up to 36 months
  description: Percentage of subjects with serious adverse events (SAEs)
  measure: Maximum tolerated dose (MTD)
  time frame: up to 36 months
  description: Assess whether the tested doses include the maximum tolerated dose (MTD) of KB707 based on the safety and response data collected during the dose escalation portion of the study
  measure: Percentage of overall response rate (ORR)
  time frame: up to 36 months
  description: Percentage of ORR
  arm group label: Dose escalation of KB707 by intratumoral (IT) injection in solid tumors
  arm group type: Experimental
  description: Dose escalation of single-agent KB707 in 3 cohorts by IT injection
  arm group label: Dose expansion of KB707 by IT injection
  arm group type: Experimental
  description: Dose escalation of single-agent KB707 in superficial and deep/visceral solid tumors
  intervention type: Biological
  intervention name: KB707
  description: Genetically modified herpes simplex type 1 virus
  arm group label: Dose escalation of KB707 by intratumoral (IT) injection in solid tumors
  arm group label: Dose expansion of KB707 by IT injection
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: David Chien, MD
  role: Study Director
  affiliation: Senior Vice President of Clinical Development
  last name: Brittani Agostini, RN, CCRC
  phone: 412-586-5830
  email: bagostini@krystalbio.com
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Melanoma
  mesh term: Osteosarcoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Carcinoma, Basal Cell