<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/NCT04420689</url>
  </required_header>
  <id_info>
    <org_study_id>ALM-488-001</org_study_id>
    <nct_id>NCT04420689</nct_id>
  </id_info>
  <brief_title>A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head &amp; Neck Surgery</brief_title>
  <official_title>Phase 1/2 Trial of ALM-488 in Patients Undergoing Head &amp; Neck Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alume Biosciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alume Biosciences, 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>
      Phase 1/2 study of ALM-488 to highlight nerves in patients undergoing head &amp; neck surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate the safety, tolerability, and efficacy of ALM-488 administered as an&#xD;
      intravenous (IV) infusion to patients undergoing head &amp; neck surgery. The study will also&#xD;
      characterize the pharmacokinetics of ALM-488 in this subject population and determine the&#xD;
      dose of ALM-488 needed to generate a fluorescence signal in nerve tissue to enable&#xD;
      fluorescence recordings and image analysis with an imaging system. The study will also&#xD;
      evaluate the effect of timing of ALM-488 administration, relative to surgery, on fluorescence&#xD;
      characteristics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 18, 2020</start_date>
  <completion_date type="Actual">February 15, 2022</completion_date>
  <primary_completion_date type="Actual">June 25, 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>Sequential Assignment</intervention_model>
    <intervention_model_description>This is a Phase 1/Phase 2 study in patients undergoing Head &amp; Neck Surgery.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of ALM-488 related Adverse Events</measure>
    <time_frame>28 (+5) days</time_frame>
    <description>Incidence of ALM-488 related Adverse Events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentration of ALM-488 in blood</measure>
    <time_frame>28 (+5) days</time_frame>
    <description>Concentration of ALM-488 in blood at varying times following ALM-488 administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose determination</measure>
    <time_frame>9 months</time_frame>
    <description>To determine the recommended dose of ALM-488.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timing determination</measure>
    <time_frame>3 months</time_frame>
    <description>To evaluate the effect of timing of administration of ALM-488.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Parotid Neoplasm</condition>
  <condition>Thyroid Neoplasms</condition>
  <condition>Head and Neck Neoplasms</condition>
  <condition>Surgery</condition>
  <condition>Nerve Injury</condition>
  <condition>Imaging</condition>
  <arm_group>
    <arm_group_label>Dose Escalation/De-Escalation Cohorts</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm of the study will include Dose Escalation/De-Escalation cohorts of ALM-488.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Timing Cohorts</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm of the study will include Dose Timing cohorts of ALM-488.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ALM-488</intervention_name>
    <description>ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.</description>
    <arm_group_label>Dose Escalation/De-Escalation Cohorts</arm_group_label>
    <arm_group_label>Dose Timing Cohorts</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A neoplasm located in the head and neck.&#xD;
&#xD;
          2. Primary surgical treatment is by parotidectomy, or thyroidectomy, or cervical neck&#xD;
             dissection.&#xD;
&#xD;
          3. Can understand and is willing to sign a written informed consent document.&#xD;
&#xD;
          4. ≥18 years of age.&#xD;
&#xD;
          5. Life expectancy of at least 6 months.&#xD;
&#xD;
          6. Normal liver and kidney functions.&#xD;
&#xD;
          7. If of childbearing potential, must have a negative urine or serum pregnancy test and&#xD;
             be using a medically acceptable form of contraception (e.g., hormonal birth control,&#xD;
             intrauterine devices, double-barrier method) or abstinence. The subject, if male, must&#xD;
             use a medically acceptable form of contraception (e.g. condom) or abstinence.&#xD;
&#xD;
          8. Plans to undergo head and neck surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior radiation or chemotherapy for any prior head and neck neoplasm.&#xD;
&#xD;
          2. Open surgery in the ipsilateral head and neck within 1 year.&#xD;
&#xD;
          3. Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary&#xD;
             events and/or heart failure within 1 year.&#xD;
&#xD;
          4. Current evidence of renal disease.&#xD;
&#xD;
          5. Pregnant or breastfeeding.&#xD;
&#xD;
          6. Unresolved acute toxicity from prior anti-cancer therapy.&#xD;
&#xD;
          7. History of fluorescein allergy.&#xD;
&#xD;
          8. Any other criteria deemed by the Principal Investigator that may prevent the patient&#xD;
             from successfully completing the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harvard-Mass Eye &amp; Ear</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>February 15, 2022</last_update_submitted>
  <last_update_submitted_qc>February 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nerve</keyword>
  <keyword>Fluorescence</keyword>
  <keyword>Surgery</keyword>
  <keyword>Imaging</keyword>
  <keyword>Real-time</keyword>
  <keyword>Intraoperative</keyword>
  <keyword>Highlighting</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Parotid Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 26, 2022</submitted>
    <returned>September 20, 2022</returned>
    <submitted>September 23, 2022</submitted>
    <returned>October 20, 2022</returned>
  </pending_results>
  <!-- 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/NCT04420689
org study id: ALM-488-001
nct id: NCT04420689
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Phase 1/2 study of ALM-488 to highlight nerves in patients undergoing head & neck surgery.
This study will evaluate the safety, tolerability, and efficacy of ALM-488 administered as an
      intravenous (IV) infusion to patients undergoing head & neck surgery. The study will also
      characterize the pharmacokinetics of ALM-488 in this subject population and determine the
      dose of ALM-488 needed to generate a fluorescence signal in nerve tissue to enable
      fluorescence recordings and image analysis with an imaging system. The study will also
      evaluate the effect of timing of ALM-488 administration, relative to surgery, on fluorescence
      characteristics.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: This is a Phase 1/Phase 2 study in patients undergoing Head & Neck Surgery.
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of ALM-488 related Adverse Events
time frame: 28 (+5) days
description: Incidence of ALM-488 related Adverse Events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
measure: Concentration of ALM-488 in blood
time frame: 28 (+5) days
description: Concentration of ALM-488 in blood at varying times following ALM-488 administration.
measure: Dose determination
time frame: 9 months
description: To determine the recommended dose of ALM-488.
measure: Timing determination
time frame: 3 months
description: To evaluate the effect of timing of administration of ALM-488.
arm group label: Dose Escalation/De-Escalation Cohorts
arm group type: Experimental
description: This arm of the study will include Dose Escalation/De-Escalation cohorts of ALM-488.
arm group label: Dose Timing Cohorts
arm group type: Experimental
description: This arm of the study will include Dose Timing cohorts of ALM-488.
intervention type: Drug
intervention name: ALM-488
description: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.
arm group label: Dose Escalation/De-Escalation Cohorts
arm group label: Dose Timing Cohorts
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Head and Neck Neoplasms
mesh term: Thyroid Neoplasms
mesh term: Parotid Neoplasms
sharing ipd: No
submitted: August 26, 2022
returned: September 20, 2022
submitted: September 23, 2022
returned: October 20, 2022