<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/NCT03769506</url>
  </required_header>
  <id_info>
    <org_study_id>ASP-1929-301</org_study_id>
    <nct_id>NCT03769506</nct_id>
  </id_info>
  <brief_title>ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy</brief_title>
  <official_title>A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 Photoimmunotherapy Versus Physician's Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of Therapy, of Which at Least One Line Must Be Systemic Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rakuten Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rakuten Medical, Inc.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 vs Physician's&#xD;
      Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous&#xD;
      Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of&#xD;
      Therapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will have an Experimental Arm and a Control Arm.&#xD;
&#xD;
      Experimental Arm:&#xD;
&#xD;
      Patients may receive repeated ASP-1929 PIT interventions for up to a maximum of 8 cycles&#xD;
      within a period of up to 12 months after randomization until the patient has complete&#xD;
      remission, progressive disease that is no longer amendable to study treatment, patient&#xD;
      experiences intolerable side effects, or patient discontinues study treatment. Repeat&#xD;
      ASP-1929 treatment cycles will be administered no less than 4 weeks from the previous&#xD;
      ASP-1929 infusion.&#xD;
&#xD;
      Control Arm:&#xD;
&#xD;
      Patients may be treated with physician's choice standard of care until the patient has&#xD;
      progressive disease, patient experiences intolerable side effects, discontinues study&#xD;
      treatment, or chooses to withdraw.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 9, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>24 months</time_frame>
    <description>PFS, defined as the time from randomization to the first occurrence of disease progression (PD), as determined by the investigator according to RECIST 1.1, or death from any cause, whichever one occurs first.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>24 months</time_frame>
    <description>OS, defined by the time interval between the patient randomization and death due to any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>24 months</time_frame>
    <description>ORR, defined by the percentage of patients with the best overall response of complete response (CR) or partial response (PR) by RECIST 1.1. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Response (CR)</measure>
    <time_frame>24 months</time_frame>
    <description>CR, defined as disappearance of all target lesions, as determined by Central Radiographic Review according to RECIST 1.1 criteria with modifications. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Response by Biopsy (CRb)</measure>
    <time_frame>24 months</time_frame>
    <description>CR by histopathologic biopsy of target tumor(s) and a repeat confirmatory histopathologic CR biopsy at least 3 months after initial CR histopathologic biopsy of the target tumor(s) for patients that do not demonstrate a CR by RECIST 1.1 with modifications. CR: Disappearance of all target lesions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DoR)</measure>
    <time_frame>24 months</time_frame>
    <description>DoR, defined as the time from first objective response (CR or PR) to the date of the first documented tumor progression, as determined by Central Radiographic Review according to RECIST 1.1 criteria with modifications or date of death due to any cause, whichever occurs first. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-Free Survival (EFS)</measure>
    <time_frame>24 months</time_frame>
    <description>EFS, defined as the time interval from randomization to a &gt;20% increase in tumor size from baseline (defined as CT scan at screening) by RECIST 1.1 with modifications, development of new locoregional disease, distant metastatic disease, or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eastern Cooperative Oncology Group (ECOG) performance status</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QoL) assessment - EORTC QLQ-C30</measure>
    <time_frame>24 months</time_frame>
    <description>Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). EORTC QLQ-C30 is a 30-item questionnaire developed to assess QoL of head and neck cancer participants and consists of five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. It has four-point scales for the first 28 items. The minimum value is 1 and maximum value is 4. Higher scores mean a worse outcome. Overall health was evaluated as a 7-point response scale as the other two questions in that scale. The minimum value is 1 and maximum value is 7. Higher scores mean a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QoL) assessment - EORTC QLQ H&amp;N 35</measure>
    <time_frame>24 months</time_frame>
    <description>Change from baseline in EORTC head and neck specific module (EORTC QLQ H&amp;N 35). EORTC QLQ-H&amp;N35 is a 35-item questionnaire developed to assess QoL of head and neck cancer participants and consists of 7 multiple-item scales that assess the symptom of pain, swallowing, senses (taste/smell), speech, social eating, social contact and sexuality. Also, six single-item scales are included to survey the presence of symptomatic problems associated with teeth, mouth=opening, dry mouth, sticky saliva, coughing, and feeling ill. The minimum value is 1 and maximum value is 4. It has 2-point scales for the last 5 items. The minimum value is 1 and maximum value is 2. For all items and scales, high scores indicate more problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QoL) assessment - EQ 5D-5L</measure>
    <time_frame>24 months</time_frame>
    <description>Change from baseline in EuroQol 5-Dimension 5-Level (EQ 5D-5L) Questionnaire. EQ-5D-5L is a 5-dimension (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) questionnaire developed to assess the patient-generated health state index score from the societal perspective and subjective perceived health. For each dimension, levels of perceived problems are coded from level 1 (minimum) to level 5 (maximum): no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems/inability (5). A second part of the questionnaire provides a visual analogue scale (VAS) for individually perceived health from 0 to 100 (corresponding to the worst to the best imaginable health).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Population Pharmacokinetics (PK) of ASP-1929</measure>
    <time_frame>12 months</time_frame>
    <description>Estimate covariate effects of ASP-1929 PK through compartmental PK modeling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of Anti-Drug Antibodies (ADA)</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">275</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>ASP-1929 Photoimmunotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of ASP-1929 Photoimmunotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physician's Choice SOC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>docetaxel, cetuximab, methotrexate, paclitaxel</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>ASP-1929 Photoimmunotherapy</intervention_name>
    <description>Use of ASP-1929 PIT therapy</description>
    <arm_group_label>ASP-1929 Photoimmunotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Physician's Choice SOC</intervention_name>
    <description>docetaxel, cetuximab, methotrexate, paclitaxel</description>
    <arm_group_label>Physician's Choice SOC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Overall Inclusion Criteria:&#xD;
&#xD;
          -  Have a histologically confirmed locoregional persistent, recurrent or second primary&#xD;
             squamous cell carcinoma of the head and neck, not amenable to curative treatment&#xD;
&#xD;
          -  Have failed or progressed on or after at least 2 lines of therapy for squamous cell&#xD;
             carcinoma of the head and neck.&#xD;
&#xD;
          -  Failed or progressed following prior platinum chemotherapy&#xD;
&#xD;
          -  Have completed prior curative radiation therapy for treatment of their head and neck&#xD;
             region&#xD;
&#xD;
          -  Have locoregional head and neck tumor site(s) that are all accessible to illumination&#xD;
&#xD;
          -  Have target tumors that are clearly measurable by contract enhanced CT scan&#xD;
&#xD;
          -  Have a life expectancy of &gt; 6 months, based on Investigator judgment&#xD;
&#xD;
          -  Male participants must agree to use contraception during the treatment period and for&#xD;
             at least 6 months after the last ASP-1929 infusion&#xD;
&#xD;
          -  Female patients of childbearing potential must not be pregnant or breastfeeding and&#xD;
             agree to follow the contraceptive guidance during the treatment period and for at&#xD;
             least 6 months after the last dose of trial intervention and must refrain from&#xD;
             breastfeeding for at least 2 months after the last ASP-1929 infusion&#xD;
&#xD;
          -  Have an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1&#xD;
&#xD;
        Overall Exclusion Criteria:&#xD;
&#xD;
          -  Have a history of significant (&gt;= Grade 3) cetuximab infusion reactions&#xD;
&#xD;
          -  Have been treated with prior systematic chemotherapy or targeted small molecule&#xD;
             therapy or radiation therapy within 2 weeks of trial Day 1 or not recovered from&#xD;
             adverse events due to a previously administered agent&#xD;
&#xD;
          -  Have been treated with an anticancer monoclonal antibody therapy within 4 weeks of&#xD;
             trial Day 1 or have not recovered from adverse events due to previously administered&#xD;
             agent&#xD;
&#xD;
          -  Have been treated with an investigational agent or intervention within 4 weeks of&#xD;
             trial Day 1 or have not recovered from adverse events, due to previously administered&#xD;
             agent or intervention&#xD;
&#xD;
          -  Have a present history of distant metastatic disease (M1)&#xD;
&#xD;
          -  Have an active undergoing treatment or have a diagnosis of an active cancer other than&#xD;
             nonmelanoma skin cancer or HNSCC&#xD;
&#xD;
          -  Have a tumor in enhanced CT or MRI scan invading a major blood vessel, unless the&#xD;
             vessel has been embolized, stented or surgically ligated to prevent potential bleeding&#xD;
             from a blood vessel&#xD;
&#xD;
          -  Have impaired hepatic function&#xD;
&#xD;
          -  Have impaired renal function&#xD;
&#xD;
          -  Have uncontrolled intercurrent illness including, but not limited to, ongoing or&#xD;
             active infection, symptomatic congestive heart failure, unstable angina pectoris,&#xD;
             cardiac arrhythmia, or psychiatric illness/social situations that would limit&#xD;
             compliance with trial requirements&#xD;
&#xD;
          -  Have been previously treated or randomized to any trial using ASP-1929 or RM-1929 PIT&#xD;
             as the study treatment&#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>Naomi Schechter</last_name>
    <role>Study Director</role>
    <affiliation>Rakuten Medical</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bogdan Veresh, MD</last_name>
    <phone>858-207-3113</phone>
    <email>clinicaltrialinfo@rakuten-med.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tien Nguyen</last_name>
      <phone>813-844-7745</phone>
    </contact>
    <investigator>
      <last_name>Matthew J. Mifsud, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Grady Health</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Frank Akuchie</last_name>
      <phone>404-942-8907</phone>
    </contact>
    <investigator>
      <last_name>Charles E. Moore, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kentucky, Albert B. Chandler Medical Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>William Beaumont Hospital</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Grace San Agustin</last_name>
      <phone>248-551-6679</phone>
    </contact>
    <investigator>
      <last_name>Jeffrey Hotaling, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University - Sidney Kimmel Medical College</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Camilo Henao</last_name>
      <phone>215-982-0009</phone>
    </contact>
    <investigator>
      <last_name>David Cognetti, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ethan Skinner</last_name>
      <phone>215-615-1611</phone>
    </contact>
    <investigator>
      <last_name>Karthik Rajasekaran, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bridget Reeves</last_name>
      <phone>713-745-1897</phone>
    </contact>
    <investigator>
      <last_name>Ann Gillenwater, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kailash Cancer Hospital and Research Center</name>
      <address>
        <city>Vadodara</city>
        <state>Gujarat</state>
        <zip>391760</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yash Damor</last_name>
      <phone>91-8469554460</phone>
    </contact>
    <investigator>
      <last_name>Rajesh Kantharia</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cancer Institute (W.I.A)</name>
      <address>
        <city>Chennai</city>
        <state>Tamilnadu</state>
        <zip>60036</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>S. Deyva Manohari</last_name>
      <phone>91-8681823668</phone>
    </contact>
    <investigator>
      <last_name>Venkatraman Radhakrishnan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aichi Cancer Center</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>464-8681</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital East</name>
      <address>
        <city>Kashiwa-shi</city>
        <state>Chiba</state>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaido</state>
        <zip>060-8648</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital</name>
      <address>
        <city>Okayama-shi</city>
        <state>Okayama</state>
        <zip>700-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Zhongzheng</city>
        <state>Taipei</state>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christy Lee</last_name>
      <phone>886-223-123-456</phone>
      <phone_ext>88858</phone_ext>
    </contact>
    <investigator>
      <last_name>Pei-Jen Lou</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chia Hui Lin</last_name>
      <phone>886-920-211-277</phone>
    </contact>
    <investigator>
      <last_name>Chun-Hung Hua</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>I-Chen Tsai</last_name>
      <phone>886-911-102-866</phone>
    </contact>
    <investigator>
      <last_name>Chen-Chi Wang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lora Chang</last_name>
      <phone>886-919-977-034</phone>
    </contact>
    <investigator>
      <last_name>Kai-Ping Chang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital #4</name>
      <address>
        <city>Dnipro</city>
        <zip>49102</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>India</country>
    <country>Japan</country>
    <country>Taiwan</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Belgium</country>
    <country>Greece</country>
    <country>Spain</country>
  </removed_countries>
  <reference>
    <citation>Kobayashi H, Furusawa A, Rosenberg A, Choyke PL. Near-infrared photoimmunotherapy of cancer: a new approach that kills cancer cells and enhances anti-cancer host immunity. Int Immunol. 2021 Jan 1;33(1):7-15. doi: 10.1093/intimm/dxaa037.</citation>
    <PMID>32496557</PMID>
  </reference>
  <reference>
    <citation>Kobayashi H, Choyke PL. Near-Infrared Photoimmunotherapy of Cancer. Acc Chem Res. 2019 Aug 20;52(8):2332-2339. doi: 10.1021/acs.accounts.9b00273. Epub 2019 Jul 23.</citation>
    <PMID>31335117</PMID>
  </reference>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rakuten Medical</keyword>
  <keyword>ASP-1929</keyword>
  <keyword>PIT</keyword>
  <keyword>Photoimmunotherapy</keyword>
  <keyword>HNC</keyword>
  <keyword>HNSCC</keyword>
  <keyword>Head and neck</keyword>
  <keyword>EGFR</keyword>
  <keyword>Cetuximab</keyword>
  <keyword>Erbitux</keyword>
  <keyword>RM-1929</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</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/NCT03769506
org study id: ASP-1929-301
nct id: NCT03769506
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 vs Physician's
      Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous
      Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of
      Therapy
The study will have an Experimental Arm and a Control Arm.

      Experimental Arm:

      Patients may receive repeated ASP-1929 PIT interventions for up to a maximum of 8 cycles
      within a period of up to 12 months after randomization until the patient has complete
      remission, progressive disease that is no longer amendable to study treatment, patient
      experiences intolerable side effects, or patient discontinues study treatment. Repeat
      ASP-1929 treatment cycles will be administered no less than 4 weeks from the previous
      ASP-1929 infusion.

      Control Arm:

      Patients may be treated with physician's choice standard of care until the patient has
      progressive disease, patient experiences intolerable side effects, discontinues study
      treatment, or chooses to withdraw.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-Free Survival (PFS)
time frame: 24 months
description: PFS, defined as the time from randomization to the first occurrence of disease progression (PD), as determined by the investigator according to RECIST 1.1, or death from any cause, whichever one occurs first.
measure: Overall Survival (OS)
time frame: 24 months
description: OS, defined by the time interval between the patient randomization and death due to any cause.
measure: Objective Response Rate (ORR)
time frame: 24 months
description: ORR, defined by the percentage of patients with the best overall response of complete response (CR) or partial response (PR) by RECIST 1.1. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
measure: Complete Response (CR)
time frame: 24 months
description: CR, defined as disappearance of all target lesions, as determined by Central Radiographic Review according to RECIST 1.1 criteria with modifications. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm.
measure: Complete Response by Biopsy (CRb)
time frame: 24 months
description: CR by histopathologic biopsy of target tumor(s) and a repeat confirmatory histopathologic CR biopsy at least 3 months after initial CR histopathologic biopsy of the target tumor(s) for patients that do not demonstrate a CR by RECIST 1.1 with modifications. CR: Disappearance of all target lesions.
measure: Duration of Response (DoR)
time frame: 24 months
description: DoR, defined as the time from first objective response (CR or PR) to the date of the first documented tumor progression, as determined by Central Radiographic Review according to RECIST 1.1 criteria with modifications or date of death due to any cause, whichever occurs first. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
measure: Event-Free Survival (EFS)
time frame: 24 months
description: EFS, defined as the time interval from randomization to a >20% increase in tumor size from baseline (defined as CT scan at screening) by RECIST 1.1 with modifications, development of new locoregional disease, distant metastatic disease, or death.
measure: Eastern Cooperative Oncology Group (ECOG) performance status
time frame: 24 months
measure: Quality of Life (QoL) assessment - EORTC QLQ-C30
time frame: 24 months
description: Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). EORTC QLQ-C30 is a 30-item questionnaire developed to assess QoL of head and neck cancer participants and consists of five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. It has four-point scales for the first 28 items. The minimum value is 1 and maximum value is 4. Higher scores mean a worse outcome. Overall health was evaluated as a 7-point response scale as the other two questions in that scale. The minimum value is 1 and maximum value is 7. Higher scores mean a better outcome.
measure: Quality of Life (QoL) assessment - EORTC QLQ H&N 35
time frame: 24 months
description: Change from baseline in EORTC head and neck specific module (EORTC QLQ H&N 35). EORTC QLQ-H&N35 is a 35-item questionnaire developed to assess QoL of head and neck cancer participants and consists of 7 multiple-item scales that assess the symptom of pain, swallowing, senses (taste/smell), speech, social eating, social contact and sexuality. Also, six single-item scales are included to survey the presence of symptomatic problems associated with teeth, mouth=opening, dry mouth, sticky saliva, coughing, and feeling ill. The minimum value is 1 and maximum value is 4. It has 2-point scales for the last 5 items. The minimum value is 1 and maximum value is 2. For all items and scales, high scores indicate more problems.
measure: Quality of Life (QoL) assessment - EQ 5D-5L
time frame: 24 months
description: Change from baseline in EuroQol 5-Dimension 5-Level (EQ 5D-5L) Questionnaire. EQ-5D-5L is a 5-dimension (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) questionnaire developed to assess the patient-generated health state index score from the societal perspective and subjective perceived health. For each dimension, levels of perceived problems are coded from level 1 (minimum) to level 5 (maximum): no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems/inability (5). A second part of the questionnaire provides a visual analogue scale (VAS) for individually perceived health from 0 to 100 (corresponding to the worst to the best imaginable health).
measure: Population Pharmacokinetics (PK) of ASP-1929
time frame: 12 months
description: Estimate covariate effects of ASP-1929 PK through compartmental PK modeling.
measure: Presence of Anti-Drug Antibodies (ADA)
time frame: 24 months
arm group label: ASP-1929 Photoimmunotherapy
arm group type: Experimental
description: Use of ASP-1929 Photoimmunotherapy
arm group label: Physician's Choice SOC
arm group type: Active Comparator
description: docetaxel, cetuximab, methotrexate, paclitaxel
intervention type: Combination Product
intervention name: ASP-1929 Photoimmunotherapy
description: Use of ASP-1929 PIT therapy
arm group label: ASP-1929 Photoimmunotherapy
intervention type: Drug
intervention name: Physician's Choice SOC
description: docetaxel, cetuximab, methotrexate, paclitaxel
arm group label: Physician's Choice SOC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Naomi Schechter
role: Study Director
affiliation: Rakuten Medical
last name: Bogdan Veresh, MD
phone: 858-207-3113
email: clinicaltrialinfo@rakuten-med.com
facility: 
status: Recruiting
contact: 
investigator: 
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status: Recruiting
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facility: 
status: Active, not recruiting
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facility: 
status: Recruiting
contact: 
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facility: 
status: Recruiting
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status: Recruiting
contact: 
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facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
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status: Active, not recruiting
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status: Recruiting
contact: 
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facility: 
status: Recruiting
contact: 
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facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
country: India
country: Japan
country: Taiwan
country: Ukraine
country: United States
country: Belgium
country: Greece
country: Spain
citation: Kobayashi H, Furusawa A, Rosenberg A, Choyke PL. Near-infrared photoimmunotherapy of cancer: a new approach that kills cancer cells and enhances anti-cancer host immunity. Int Immunol. 2021 Jan 1;33(1):7-15. doi: 10.1093/intimm/dxaa037.
PMID: 32496557
citation: Kobayashi H, Choyke PL. Near-Infrared Photoimmunotherapy of Cancer. Acc Chem Res. 2019 Aug 20;52(8):2332-2339. doi: 10.1021/acs.accounts.9b00273. Epub 2019 Jul 23.
PMID: 31335117
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
sharing ipd: No