<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/NCT04419532</url>
  </required_header>
  <id_info>
    <org_study_id>DS1055-A-J101</org_study_id>
    <nct_id>NCT04419532</nct_id>
  </id_info>
  <brief_title>A Study Evaluating DS-1055a in Participants With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors</brief_title>
  <official_title>A Phase 1, First In Human Study of DS-1055a in Subjects With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daiichi Sankyo Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Daiichi Sankyo, 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and tolerability of DS-1055a in&#xD;
      participants with relapsed or refractory locally advanced or metastatic solid tumors for&#xD;
      which no standard treatment is available.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This Phase 1, open-label, non-randomized, dose escalation, first-in-human study will assess&#xD;
      the safety and tolerability of DS-1055a, determine the maximum tolerated dose of DS-1055a,&#xD;
      pharmacokinetic (PK) properties of DS-1055a, and the incidence of anti-drug antibodies (ADAs)&#xD;
      against DS-1055a and other antibodies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 9, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with dose-limiting toxicities</measure>
    <time_frame>21 days of Cycle 1</time_frame>
    <description>A dose-limiting toxicity (DLT) is defined as any treatment-emergent adverse event (TEAE) that occurs during the DLT evaluation period (21 days), excluding toxicities clearly related to disease progression or intercurrent illness or to concomitant medications or to concomitant procedures and is Grade 3 or above according to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0, with certain specified exceptions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Baseline up to approximately 3 years</time_frame>
    <description>Adverse events were assessed using National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration (Cmax)</measure>
    <time_frame>Priming Dose Cycle 1 Day 1 to Cycle 4 Day 1, and every 2 cycles from Cycle 4 to end of treatment, within approximately 2 years (each cycle is 21 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Plasma Concentration (Tmax)</measure>
    <time_frame>Priming Dose Cycle 1 Day 1 to Cycle 4 Day 1, and every 2 cycles from Cycle 4 to end of treatment, within approximately 2 years (each cycle is 21 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve Up to Last Quantifiable Time (AUClast) and During Dosing Interval (AUCtau)</measure>
    <time_frame>Priming Dose Cycle 1 Day 1 to Cycle 4 Day 1, and every 2 cycles from Cycle 4 to end of treatment, within approximately 2 years (each cycle is 21 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Observed Concentration (Ctrough)</measure>
    <time_frame>Priming Dose Cycle 1 Day 1 to Cycle 4 Day 1, and every 2 cycles from Cycle 4 to end of treatment, within approximately 2 years (each cycle is 21 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Incidence of Anti-Drug Antibodies (ADA) and Other Antibodies</measure>
    <time_frame>From pre-treatment to follow-up visit (within approximately 2 years)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Solid Tumor</condition>
  <condition>Advanced Cancer</condition>
  <condition>Metastatic Solid Tumor</condition>
  <arm_group>
    <arm_group_label>Dose Escalation (DS-1055a)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be enrolled into groups with each group receiving an increased dose from the previous group as safety assessments permit in order to determine the optimal dose for safety and tolerability.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DS-1055a</intervention_name>
    <description>Administered as an intravenous infusion on Day 1 of every 21-day cycle following low dose administration(s) in priming dose period.&#xD;
Infusion duration: 180 minutes for the first infusion, and if no infusion-related reaction, 120 minutes for subsequent infusions</description>
    <arm_group_label>Dose Escalation (DS-1055a)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has a histopathologically documented locally advanced or metastatic head and neck,&#xD;
             gastric, esophageal cancer, non-small cell lung cancer, or melanoma. Participants with&#xD;
             other types of solid tumors may be eligible following discussion with the Sponsor.&#xD;
&#xD;
          -  Has a relapsed or refractory disease that is not amenable to curative standard&#xD;
             therapy.&#xD;
&#xD;
          -  Is 18 years of age or older.&#xD;
&#xD;
          -  Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1, with no&#xD;
             deterioration for two weeks.&#xD;
&#xD;
          -  Has a measurable disease based on Response Evaluation Criteria in Solid Tumors&#xD;
             (RECIST) version 1.1.&#xD;
&#xD;
          -  Has adequate organ function within 7 days before enrollment.&#xD;
&#xD;
          -  Is able to provide written informed consent and is willing and able to comply with the&#xD;
             protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a concurrently active second malignancy, other than adequately treated&#xD;
             non-melanoma skin cancers, in situ melanoma or in situ cervical cancer. Participants&#xD;
             with history of the second malignancy have been disease-free for &lt;3 years.&#xD;
&#xD;
          -  Has a history of (non-infectious) interstitial lung disease (ILD) that required&#xD;
             steroids, currently has ILD, or when suspected ILD cannot be ruled out by imaging at&#xD;
             screening.&#xD;
&#xD;
          -  Has a history of severe pulmonary compromise or requirement of supplemental oxygen&#xD;
             within 6 months before enrollment.&#xD;
&#xD;
          -  Has active hepatitis B or hepatitis C virus infection.&#xD;
&#xD;
          -  Has received prior immunotherapy with a Grade 3 or higher, or any unresolved ≥Grade 2&#xD;
             immune-related adverse event.&#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>Clinical Study Leader</last_name>
    <role>Study Director</role>
    <affiliation>Daiichi Sankyo, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>(Asia sites) Daiichi Sankyo Contact for Clinical Trial Information</last_name>
    <phone>+81-3-6225-1111(M-F 9-5 JST)</phone>
    <email>dsclinicaltrial@daiichisankyo.co.jp</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>(US sites) Daiichi Sankyo Contact for Clinical Trial Information</last_name>
    <phone>908-992-6400</phone>
    <email>CTRinfo@dsi.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Center</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>See Central Contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Chuo Ku</city>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>See Central Contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital East</name>
      <address>
        <city>Kashiwa</city>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>See Central Contact</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cancer Institute Hospital of JFCR</name>
      <address>
        <city>Koto-Ku</city>
        <zip>135-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>See Central Contact</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Japan</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>July 14, 2023</last_update_submitted>
  <last_update_submitted_qc>July 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Solid Tumor</keyword>
  <keyword>Advanced Cancer</keyword>
  <keyword>Metastatic Solid Tumor</keyword>
  <keyword>DS-1055a</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.</ipd_time_frame>
    <ipd_access_criteria>Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/daiichi-sankyo/</ipd_url>
  </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/NCT04419532
org study id: DS1055-A-J101
nct id: NCT04419532
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to assess the safety and tolerability of DS-1055a in
      participants with relapsed or refractory locally advanced or metastatic solid tumors for
      which no standard treatment is available.
This Phase 1, open-label, non-randomized, dose escalation, first-in-human study will assess
      the safety and tolerability of DS-1055a, determine the maximum tolerated dose of DS-1055a,
      pharmacokinetic (PK) properties of DS-1055a, and the incidence of anti-drug antibodies (ADAs)
      against DS-1055a and other antibodies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with dose-limiting toxicities
time frame: 21 days of Cycle 1
description: A dose-limiting toxicity (DLT) is defined as any treatment-emergent adverse event (TEAE) that occurs during the DLT evaluation period (21 days), excluding toxicities clearly related to disease progression or intercurrent illness or to concomitant medications or to concomitant procedures and is Grade 3 or above according to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0, with certain specified exceptions.
measure: Number of participants with adverse events
time frame: Baseline up to approximately 3 years
description: Adverse events were assessed using National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0.
measure: Maximum Plasma Concentration (Cmax)
time frame: Priming Dose Cycle 1 Day 1 to Cycle 4 Day 1, and every 2 cycles from Cycle 4 to end of treatment, within approximately 2 years (each cycle is 21 days)
measure: Time to Reach Maximum Plasma Concentration (Tmax)
time frame: Priming Dose Cycle 1 Day 1 to Cycle 4 Day 1, and every 2 cycles from Cycle 4 to end of treatment, within approximately 2 years (each cycle is 21 days)
measure: Area Under the Plasma Concentration-Time Curve Up to Last Quantifiable Time (AUClast) and During Dosing Interval (AUCtau)
time frame: Priming Dose Cycle 1 Day 1 to Cycle 4 Day 1, and every 2 cycles from Cycle 4 to end of treatment, within approximately 2 years (each cycle is 21 days)
measure: Minimum Observed Concentration (Ctrough)
time frame: Priming Dose Cycle 1 Day 1 to Cycle 4 Day 1, and every 2 cycles from Cycle 4 to end of treatment, within approximately 2 years (each cycle is 21 days)
measure: The Incidence of Anti-Drug Antibodies (ADA) and Other Antibodies
time frame: From pre-treatment to follow-up visit (within approximately 2 years)
arm group label: Dose Escalation (DS-1055a)
arm group type: Experimental
description: Participants will be enrolled into groups with each group receiving an increased dose from the previous group as safety assessments permit in order to determine the optimal dose for safety and tolerability.
intervention type: Drug
intervention name: DS-1055a
description: Administered as an intravenous infusion on Day 1 of every 21-day cycle following low dose administration(s) in priming dose period.
Infusion duration: 180 minutes for the first infusion, and if no infusion-related reaction, 120 minutes for subsequent infusions
arm group label: Dose Escalation (DS-1055a)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Study Leader
role: Study Director
affiliation: Daiichi Sankyo, Inc.
last name: (Asia sites) Daiichi Sankyo Contact for Clinical Trial Information
phone: +81-3-6225-1111(M-F 9-5 JST)
email: dsclinicaltrial@daiichisankyo.co.jp
last name: (US sites) Daiichi Sankyo Contact for Clinical Trial Information
phone: 908-992-6400
email: CTRinfo@dsi.com
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Canada
country: Japan
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: Yes
ipd description: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
ipd access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
ipd url: https://vivli.org/ourmember/daiichi-sankyo/