<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/NCT02980341</url>
  </required_header>
  <id_info>
    <org_study_id>U31402-A-J101</org_study_id>
    <secondary_id>JapicCTI-163401</secondary_id>
    <nct_id>NCT02980341</nct_id>
  </id_info>
  <brief_title>Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer</brief_title>
  <official_title>Phase 1/2, Multicenter, Open-label, Multiple-Dose First-in-human Study of U3-1402, in Subjects With HER3 Positive Metastatic Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daiichi Sankyo Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Daiichi Sankyo, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Daiichi Sankyo, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, three-part, multiple-dose study to evaluate safety, tolerability, and&#xD;
      efficacy of U3-1402 in patients with HER3-positive metastatic breast cancer. HER3 is a unique&#xD;
      member of the human epidermal growth factor receptor, which defines a certain type of cancer.&#xD;
&#xD;
      The number of patients and treatment cycles are not fixed in this study. Subjects who&#xD;
      continue to derive clinical benefit from the study treatment in the absence of withdrawal of&#xD;
      consent, progressive disease (PD), unacceptable toxicity, or death may continue the study&#xD;
      treatment until the end of the trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Actual">August 16, 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>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants experiencing adverse events (AEs)</measure>
    <time_frame>within about 6 months</time_frame>
    <description>AEs will be collected systematically from signing of the informed consent form (ICF) through 28 days after last dose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with tumor response throughout the study using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1</measure>
    <time_frame>From screening until disease progresses, within about 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dose Escalation Part: Area under the serum concentration time curve (AUC) of U3-1402</measure>
    <time_frame>Cycle 1, Day 1 to Cycle 8, Day 1 (148 days)</time_frame>
    <description>Samples are obtained for all secondary outcome measures in the Dose Escalation Part at Cycle 1: Days 1, 2, 4, 8, 15; Cycle 2: Days 1, 8, 15; Cycle 3: Days 1, 2, 4, 8, 15; Cycles 4, 6, 8: Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Finding Part: AUC of U3-1402</measure>
    <time_frame>Cycle 1, Day 1 to Cycle 8, Day 1 (148 days)</time_frame>
    <description>Samples are obtained for all secondary outcome measures in the Dose Finding Part for the following categories:&#xD;
Cohorts 1 and 2: at Cycle 1: Days 1, 2, 4, 8, 15; Cycle 2: Day 1; Cycle 3: Days 1, 8, 15; Cycles 4, 5, 6, 8: Day 1&#xD;
Cohort 3: at Cycles 1, 2, 3: Days 1, 8, 15; Cycles 4, 5, 6, 8: Day 1&#xD;
Cohorts 4 and 5: at Cycle 1: Days 1, 4, 8; Cycle 2: Day 1; Cycle 3: Days 1, 4, 8; Cycle 4: Days 1, 8, 15; Cycles 5, 6, 8: Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Expansion Part: AUC of U3-1402</measure>
    <time_frame>Cycle 1, Day 1 to Cycle 8, Day 1 (148 days)</time_frame>
    <description>Samples are obtained for all secondary outcome measures in the Dose Expansion Part at Cycle 1, Days 1, 2, 4, 8, 15; Cycle 2, Day 1; Cycle 3, Days 1, 8, 15; Cycles 4, 6, 8; Day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Escalation Part: Maximum plasma concentration (Cmax) of U3-1402</measure>
    <time_frame>within 148 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Finding Part: Cmax of U3-1402</measure>
    <time_frame>within 148 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Expansion Part: Cmax of U3-1402</measure>
    <time_frame>within 148 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Escalation Part: Time to maximum plasma concentration (Tmax) of U3-1402</measure>
    <time_frame>within 148 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Finding Part: Tmax of U3-1402</measure>
    <time_frame>within 148 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Expansion Part: Tmax of U3-1402</measure>
    <time_frame>within 148 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Escalation Part: Change in Total anti-HER3 antibody from U3-1402</measure>
    <time_frame>Baseline, 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Finding Part: Change in Total anti-HER3 antibody from U3-1402</measure>
    <time_frame>Baseline, 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Expansion Part: Change in Total anti-HER3 antibody from U3-1402</measure>
    <time_frame>Baseline, 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Escalation Part: Change in MAAA-1181 level from U3-1402</measure>
    <time_frame>within 148 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Finding Part: Change in MAAA-1181 level from U3-1402</measure>
    <time_frame>within 148 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Expansion Part: Change in MAAA-1181 level from U3-1402</measure>
    <time_frame>within 148 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">184</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Dose Escalation Part</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive U3-1402 from 1.6 mg/kg to 9.6 mg/kg, administered via intravenous (IV) solution at 3-week intervals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Finding Part</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive 1 of 5 different U3-1402 dosing regimens, administered via IV solution at 2 or 3-week intervals at doses at or lower than those studied in the Dose Escalation Part.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion Part</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with HER3 high, HER2 negative, HR positive status receive 4.8 mg/kg or 6.4 mg/kg of U3-1402 administered via intravenous (IV) solution at 3-week intervals. Participants with HER3 low, HER2 negative, HR positive status receive 6.4 mg/kg of U3-1402 administered via intravenous (IV) solution at 3-week intervals. Participants with HER3 high, HER2 negative, HR negative status receive 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Patritumab Deruxtecan</intervention_name>
    <description>U3-1402 consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a)</description>
    <arm_group_label>Dose Escalation Part</arm_group_label>
    <arm_group_label>Dose Expansion Part</arm_group_label>
    <arm_group_label>Dose Finding Part</arm_group_label>
    <other_name>U3-1402</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Is 18 Years and older in the United States or 20 Years and older in Japan&#xD;
&#xD;
          2. Has a pathologically documented advanced/unresectable or metastatic breast cancer&#xD;
&#xD;
          3. Documented HER3-positive disease measured by immunohistochemistry (IHC)&#xD;
&#xD;
          4. Has disease that is refractory to or intolerable with standard treatment, or for which&#xD;
             standard treatment no longer is available&#xD;
&#xD;
          5. Has an Eastern Cooperative Oncology Group Performance Status 0-1&#xD;
&#xD;
          6. Has Left Ventricular Ejection Fraction ≥ 50%&#xD;
&#xD;
          7. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST)&#xD;
             version 1.1&#xD;
&#xD;
             Additional Inclusion Criteria for Dose Finding Part and Dose Expansion Part:&#xD;
&#xD;
          8. Has received 2-6 prior chemotherapy regimens for breast cancer, at least 2 of which&#xD;
             were administered for treatment of advanced/unresectable or metastatic disease. At&#xD;
             least 1 prior chemotherapeutic regimen must have included a taxane, administered in&#xD;
             the neoadjuvant, adjuvant, or advanced setting. (With exception of Dose Expansion Part&#xD;
             TNBC cohort. See additional inclusion criteria for Dose Expansion Part TNBC cohort.)&#xD;
&#xD;
             Additional Inclusion Criteria for Dose Expansion Part Only:&#xD;
&#xD;
          9. Is able to submit a fresh tumor biopsy sample prior to starting study treatment if not&#xD;
             already submitted for HER3 expression&#xD;
&#xD;
         10. Has documented hormone (estrogen and/or progesterone) receptor (HR)-positive and HER2&#xD;
             negative expression according to American Society of Clinical Oncology - College of&#xD;
             American Pathologists (ASCO-CAP) guidelines. (With exception of Dose Expansion Part&#xD;
             TNBC cohort. See additional inclusion criteria for Dose Expansion Part TNBC cohort.)&#xD;
&#xD;
             Additional Inclusion Criteria for Dose Expansion Part TNBC cohort Only:&#xD;
&#xD;
         11. Has documented hormone (estrogen and progesterone) receptor (HR)-negative and HER2&#xD;
             negative expression according to American Society of Clinical Oncology - College of&#xD;
             American Pathologists (ASCO-CAP) guidelines&#xD;
&#xD;
         12. Has progressed after receiving 1 to 2 prior chemotherapy regimens for&#xD;
             advanced/unresectable or metastatic breast cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior treatment with a HER3 antibody&#xD;
&#xD;
          2. Prior treatment with an antibody-drug conjugate (ADC) which consists of an exatecan&#xD;
             derivative that is a topoisomerase I inhibitor (eg, DS-8201)&#xD;
&#xD;
          3. Has a medical history of symptomatic congestive heart failure (New York Heart&#xD;
             Association classes II-IV) or serious cardiac arrhythmia requiring treatment&#xD;
&#xD;
          4. Has a medical history of myocardial infarction or unstable angina&#xD;
&#xD;
          5. Has a corrected QT prolongation to &gt; 450 millisecond (ms) in males and &gt; 470 ms in&#xD;
             females&#xD;
&#xD;
          6. Has a medical history of clinically significant lung diseases (eg, interstitial&#xD;
             pneumonia, pneumonitis, pulmonary fibrosis, and radiation pneumonitis) or who are&#xD;
             suspected to have these diseases by imaging at screening period&#xD;
&#xD;
          7. Has clinically significant corneal disease&#xD;
&#xD;
             Additional Exclusion Criteria for Dose Expansion Part:&#xD;
&#xD;
          8. Prior treatment with an govitecan derivative (eg, IMMU-132).&#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>Global Clinical Leader</last_name>
    <role>Study Director</role>
    <affiliation>Daiichi Sankyo, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southeastern Regional Medical Center</name>
      <address>
        <city>Newnan</city>
        <state>Georgia</state>
        <zip>30265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114-2752</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Einstein College of Medicine</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A.</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030-4009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mays Cancer Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Hokkaido Cancer Center</name>
      <address>
        <city>Sapporo-Shi</city>
        <state>Hokkaido</state>
        <zip>003-0804</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital East</name>
      <address>
        <city>Chiba</city>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukushima Medical University Hospital</name>
      <address>
        <city>Fukushima</city>
        <zip>960-1295</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital</name>
      <address>
        <city>Hiroshima</city>
        <zip>730-518</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hakuaikai Social Medical Corporation Sagara Hospital</name>
      <address>
        <city>Kagoshima</city>
        <zip>892-0833</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanagawa Cancer Center</name>
      <address>
        <city>Kanagawa</city>
        <zip>241-0815</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kumamoto University Hospital</name>
      <address>
        <city>Kumamoto</city>
        <zip>860-8556</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aichi Cancer Center Hospital</name>
      <address>
        <city>Nagoya</city>
        <zip>464-8681</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagoya City University Hospital</name>
      <address>
        <city>Nagoya</city>
        <zip>467-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Osaka National Hospital</name>
      <address>
        <city>Osaka</city>
        <zip>540-0006</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka International Cancer Institute</name>
      <address>
        <city>Osaka</city>
        <zip>541-8567</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kindai University Hospital</name>
      <address>
        <city>Osaka</city>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Medical University International Medical Center</name>
      <address>
        <city>Saitama</city>
        <zip>350-1298</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Cancer Center</name>
      <address>
        <city>Saitama</city>
        <zip>362 0806</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cancer Institute Hospital of Japanese Foundation for Cancer Research</name>
      <address>
        <city>Tokyo</city>
        <zip>135-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <disposition_first_submitted>July 18, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>July 27, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 29, 2022</disposition_first_posted>
  <last_update_submitted>July 13, 2023</last_update_submitted>
  <last_update_submitted_qc>July 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oncology</keyword>
  <keyword>HER3</keyword>
  <keyword>Antibody drug conjugate</keyword>
  <keyword>Developmental Phase I/II</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Patritumab deruxtecan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data (IPD) 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>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Studies 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 from 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, but a results disposition has been submitted           -->
</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/NCT02980341
org study id: U31402-A-J101
secondary id: JapicCTI-163401
nct id: NCT02980341
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
This is an open-label, three-part, multiple-dose study to evaluate safety, tolerability, and
      efficacy of U3-1402 in patients with HER3-positive metastatic breast cancer. HER3 is a unique
      member of the human epidermal growth factor receptor, which defines a certain type of cancer.

      The number of patients and treatment cycles are not fixed in this study. Subjects who
      continue to derive clinical benefit from the study treatment in the absence of withdrawal of
      consent, progressive disease (PD), unacceptable toxicity, or death may continue the study
      treatment until the end of the trial.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants experiencing adverse events (AEs)
time frame: within about 6 months
description: AEs will be collected systematically from signing of the informed consent form (ICF) through 28 days after last dose
measure: Number of participants with tumor response throughout the study using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
time frame: From screening until disease progresses, within about 6 months
measure: Dose Escalation Part: Area under the serum concentration time curve (AUC) of U3-1402
time frame: Cycle 1, Day 1 to Cycle 8, Day 1 (148 days)
description: Samples are obtained for all secondary outcome measures in the Dose Escalation Part at Cycle 1: Days 1, 2, 4, 8, 15; Cycle 2: Days 1, 8, 15; Cycle 3: Days 1, 2, 4, 8, 15; Cycles 4, 6, 8: Day 1
measure: Dose Finding Part: AUC of U3-1402
time frame: Cycle 1, Day 1 to Cycle 8, Day 1 (148 days)
description: Samples are obtained for all secondary outcome measures in the Dose Finding Part for the following categories:
Cohorts 1 and 2: at Cycle 1: Days 1, 2, 4, 8, 15; Cycle 2: Day 1; Cycle 3: Days 1, 8, 15; Cycles 4, 5, 6, 8: Day 1
Cohort 3: at Cycles 1, 2, 3: Days 1, 8, 15; Cycles 4, 5, 6, 8: Day 1
Cohorts 4 and 5: at Cycle 1: Days 1, 4, 8; Cycle 2: Day 1; Cycle 3: Days 1, 4, 8; Cycle 4: Days 1, 8, 15; Cycles 5, 6, 8: Day 1
measure: Dose Expansion Part: AUC of U3-1402
time frame: Cycle 1, Day 1 to Cycle 8, Day 1 (148 days)
description: Samples are obtained for all secondary outcome measures in the Dose Expansion Part at Cycle 1, Days 1, 2, 4, 8, 15; Cycle 2, Day 1; Cycle 3, Days 1, 8, 15; Cycles 4, 6, 8; Day 1
measure: Dose Escalation Part: Maximum plasma concentration (Cmax) of U3-1402
time frame: within 148 days
measure: Dose Finding Part: Cmax of U3-1402
time frame: within 148 days
measure: Dose Expansion Part: Cmax of U3-1402
time frame: within 148 days
measure: Dose Escalation Part: Time to maximum plasma concentration (Tmax) of U3-1402
time frame: within 148 days
measure: Dose Finding Part: Tmax of U3-1402
time frame: within 148 days
measure: Dose Expansion Part: Tmax of U3-1402
time frame: within 148 days
measure: Dose Escalation Part: Change in Total anti-HER3 antibody from U3-1402
time frame: Baseline, 6 months
measure: Dose Finding Part: Change in Total anti-HER3 antibody from U3-1402
time frame: Baseline, 6 months
measure: Dose Expansion Part: Change in Total anti-HER3 antibody from U3-1402
time frame: Baseline, 6 months
measure: Dose Escalation Part: Change in MAAA-1181 level from U3-1402
time frame: within 148 days
measure: Dose Finding Part: Change in MAAA-1181 level from U3-1402
time frame: within 148 days
measure: Dose Expansion Part: Change in MAAA-1181 level from U3-1402
time frame: within 148 days
arm group label: Dose Escalation Part
arm group type: Experimental
description: Participants receive U3-1402 from 1.6 mg/kg to 9.6 mg/kg, administered via intravenous (IV) solution at 3-week intervals.
arm group label: Dose Finding Part
arm group type: Experimental
description: Participants receive 1 of 5 different U3-1402 dosing regimens, administered via IV solution at 2 or 3-week intervals at doses at or lower than those studied in the Dose Escalation Part.
arm group label: Dose Expansion Part
arm group type: Experimental
description: Participants with HER3 high, HER2 negative, HR positive status receive 4.8 mg/kg or 6.4 mg/kg of U3-1402 administered via intravenous (IV) solution at 3-week intervals. Participants with HER3 low, HER2 negative, HR positive status receive 6.4 mg/kg of U3-1402 administered via intravenous (IV) solution at 3-week intervals. Participants with HER3 high, HER2 negative, HR negative status receive 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
intervention type: Drug
intervention name: Patritumab Deruxtecan
description: U3-1402 consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a)
arm group label: Dose Escalation Part
arm group label: Dose Expansion Part
arm group label: Dose Finding Part
other name: U3-1402
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Global Clinical Leader
role: Study Director
affiliation: Daiichi Sankyo, Inc.
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country: Japan
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Patritumab deruxtecan
sharing ipd: Yes
ipd description: De-identified individual participant data (IPD) 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: Clinical Study Report (CSR)
ipd time frame: Studies 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 from 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/