<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/NCT03253185</url>
  </required_header>
  <id_info>
    <org_study_id>M16-310</org_study_id>
    <nct_id>NCT03253185</nct_id>
  </id_info>
  <brief_title>A Study of SC-007 in Subjects With Advanced Cancer</brief_title>
  <official_title>An Open Label Study of SC-007 in Subjects With Advanced Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, open-label, Phase 1 study in participants with colorectal cancer (CRC)&#xD;
      or gastric cancer to study the safety and tolerability of SC-007 and consists of Part A (dose&#xD;
      regimen finding) in participants with CRC followed by Part A in participants with gastric&#xD;
      cancer. Part B (dose expansion) will enroll participants into separate disease specific&#xD;
      cohorts of CRC or gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Benefit/Risk Imbalance&#xD;
  </why_stopped>
  <start_date type="Actual">September 13, 2017</start_date>
  <completion_date type="Actual">April 2, 2018</completion_date>
  <primary_completion_date type="Actual">March 20, 2018</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 (DLTs)</measure>
    <time_frame>Minimum first cycle of dosing (Up to 21 days)</time_frame>
    <description>DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Benefit Rate (CBR)</measure>
    <time_frame>Approximately 4 years</time_frame>
    <description>CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR+SD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>Approximately 4 years</time_frame>
    <description>PFS time is defined as the time from the participant's first dose of study drug (Day 1) to either the participant's disease progression or death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed plasma concentrations at trough (Ctrough) of SC-007</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Observed plasma concentrations at trough of SC-007</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Anti-therapeutic Antibodies (ATAs) against SC-007</measure>
    <time_frame>Approximately 4 years</time_frame>
    <description>Incidence of ATAs against SC-007</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Approximately 4 years</time_frame>
    <description>OS is defined as the time from the participant's first dose date to death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half life (T1/2) of SC-007</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Terminal half life of SC-007</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>Approximately 4 years</time_frame>
    <description>ORR is defined as the proportion of participants with complete response or partial response (CR+PR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>Approximately 4 years</time_frame>
    <description>DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Cmax (Tmax) of SC-007</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Time to Cmax of SC-007</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-007</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Area under the plasma concentration-time curve within a dosing interval of SC-007</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QTcF Change from Baseline</measure>
    <time_frame>Up to 9 weeks based on 3 cycles of dosing (21-day cycles)</time_frame>
    <description>QT interval measurement corrected by Fridericia's formula (QTcF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed serum concentration (Cmax) of SC-007</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Maximum observed serum concentration of SC-007</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Colorectal Cancer (CRC)</condition>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>SC-007</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SC-007 intravenous (IV) (various doses and dose regimens)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SC-007</intervention_name>
    <description>intravenous</description>
    <arm_group_label>SC-007</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed advanced metastatic or unresectable advanced&#xD;
             colorectal cancer (CRC) or gastric cancer that is relapsed, refractory, or progressive&#xD;
             after:&#xD;
&#xD;
          -  CRC: at least 2 prior systemic regimens in the metastatic setting, and as appropriate&#xD;
             in patients whose tumors are microsatellite instability-high (MSI-H), pembrolizumab as&#xD;
             well.&#xD;
&#xD;
          -  Gastric cancer (including gastric and EGJ cancers): at least 2 prior systemic regimens&#xD;
             in adjuvant, advanced, or metastatic setting and, as appropriate, a human epidermal&#xD;
             growth factor receptor 2 (HER2) targeted agent.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
&#xD;
          -  Adequate hematologic, hepatic, and renal function.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any significant medical condition that, in the opinion of the investigator or sponsor,&#xD;
             may place the participant at undue risk from the study.&#xD;
&#xD;
          -  Has electrocardiogram (ECG) abnormalities that make QT interval corrected (QTc)&#xD;
             evaluation difficult.&#xD;
&#xD;
          -  Prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AbbVie Inc.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905-0001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University-School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gabrail Cancer Center Research</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology-Sarah Cannon Research Institute</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>South Texas Accelerated Research Therapeutics</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>April 25, 2018</last_update_submitted>
  <last_update_submitted_qc>April 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Advanced cancer</keyword>
  <keyword>Esophagogastric junction (EGJ) cancers</keyword>
  <keyword>Maximum tolerated dose (MTD)</keyword>
  <keyword>Maximum Tolerated Dose</keyword>
  <keyword>Pharmacokinetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03253185
org study id: M16-310
nct id: NCT03253185
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a multicenter, open-label, Phase 1 study in participants with colorectal cancer (CRC)
      or gastric cancer to study the safety and tolerability of SC-007 and consists of Part A (dose
      regimen finding) in participants with CRC followed by Part A in participants with gastric
      cancer. Part B (dose expansion) will enroll participants into separate disease specific
      cohorts of CRC or gastric cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with dose-limiting toxicities (DLTs)
time frame: Minimum first cycle of dosing (Up to 21 days)
description: DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
measure: Clinical Benefit Rate (CBR)
time frame: Approximately 4 years
description: CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR+SD).
measure: Progression Free Survival (PFS)
time frame: Approximately 4 years
description: PFS time is defined as the time from the participant's first dose of study drug (Day 1) to either the participant's disease progression or death due to any cause.
measure: Observed plasma concentrations at trough (Ctrough) of SC-007
time frame: Approximately 1 year
description: Observed plasma concentrations at trough of SC-007
measure: Incidence of Anti-therapeutic Antibodies (ATAs) against SC-007
time frame: Approximately 4 years
description: Incidence of ATAs against SC-007
measure: Overall Survival (OS)
time frame: Approximately 4 years
description: OS is defined as the time from the participant's first dose date to death due to any cause.
measure: Terminal half life (T1/2) of SC-007
time frame: Approximately 1 year
description: Terminal half life of SC-007
measure: Objective Response Rate (ORR)
time frame: Approximately 4 years
description: ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
measure: Duration of Response (DOR)
time frame: Approximately 4 years
description: DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.
measure: Time to Cmax (Tmax) of SC-007
time frame: Approximately 1 year
description: Time to Cmax of SC-007
measure: Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-007
time frame: Approximately 1 year
description: Area under the plasma concentration-time curve within a dosing interval of SC-007
measure: QTcF Change from Baseline
time frame: Up to 9 weeks based on 3 cycles of dosing (21-day cycles)
description: QT interval measurement corrected by Fridericia's formula (QTcF)
measure: Maximum observed serum concentration (Cmax) of SC-007
time frame: Approximately 1 year
description: Maximum observed serum concentration of SC-007
arm group label: SC-007
arm group type: Experimental
description: SC-007 intravenous (IV) (various doses and dose regimens)
intervention type: Drug
intervention name: SC-007
description: intravenous
arm group label: SC-007
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: AbbVie Inc.
role: Study Director
affiliation: AbbVie
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Stomach Neoplasms
sharing ipd: Undecided