<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/NCT03035279</url>
  </required_header>
  <id_info>
    <org_study_id>M16-312</org_study_id>
    <nct_id>NCT03035279</nct_id>
  </id_info>
  <brief_title>A Study of SC-006 and in Combination With ABBV-181 in Subjects With Advanced Colorectal Cancer</brief_title>
  <official_title>An Open Label Phase 1 Study of SC-006 as a Single Agent and in Combination With ABBV-181 in Subjects With Advanced Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a multicenter, open-label, Phase 1 study of SC-006 given as a single agent and in&#xD;
      combination with ABBV-181 in participants with advanced colorectal cancer (CRC), and consists&#xD;
      of Part A (single agent SC-006 dose regimen finding), followed by Part B (single agent SC-006&#xD;
      dose expansion), and Part C (SC-006 and ABBV-181 combination escalation and expansion). Part&#xD;
      A (dose regimen finding) will involve dose escalation and possible dose interval modification&#xD;
      to define the maximum tolerated dose (MTD) and/or recommended Part B dose and schedule. Part&#xD;
      B (dose expansion) will enroll additional participants who will be treated with a study drug&#xD;
      dose at or below the MTD determined in Part A. Part C is dose escalation of SC-006 and fixed&#xD;
      dose of ABBV-181 in combination. Recommended dose cohort of SC-006 with ABBV-181 will be&#xD;
      expanded.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Strategic considerations&#xD;
  </why_stopped>
  <start_date type="Actual">March 8, 2017</start_date>
  <completion_date type="Actual">March 28, 2019</completion_date>
  <primary_completion_date type="Actual">March 28, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with dose-limiting toxicities (DLT)</measure>
    <time_frame>Minimum first cycle of dosing (21-day cycles)</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>Overall Survival (OS)</measure>
    <time_frame>Approximately 2 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>Progression Free Survival (PFS)</measure>
    <time_frame>Approximately 2 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>Time to Cmax (Tmax) of SC-006</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Time to Cmax of SC-006</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-006</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Area under the plasma concentration-time curve within a dosing interval of SC-006</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Clinical Benefit (DOCB)</measure>
    <time_frame>Approximately 2 years</time_frame>
    <description>DOCB is defined as the time from the initial partial response (PR), complete response (CR), or stable disease to disease progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>Approximately 2 years</time_frame>
    <description>ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR), as determined by Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half life (T1/2) of SC-006</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Terminal half life (T1/2) of SC-006</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR)</measure>
    <time_frame>Approximately 2 years</time_frame>
    <description>DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression or death, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed plasma concentrations at trough (Ctrough) of SC-006</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Observed plasma concentrations at trough of SC-006</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Benefit Rate (CBR) defined as CR, PR, or stable disease (SD)</measure>
    <time_frame>Approximately 2 years</time_frame>
    <description>CBR is defined as the percentage of participants who achieve a best response of CR, PR, or stable disease (SD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed serum concentration (Cmax) of SC-006</measure>
    <time_frame>Approximately 1 year</time_frame>
    <description>Maximum observed serum concentration of SC-006</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SC-006 Dose regimen finding</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SC-006 Dose expansion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SC-006 and ABBV-181 Combination escalation and expansion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SC-006</intervention_name>
    <description>Intravenous</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_label>Arm C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABBV-181</intervention_name>
    <description>Intravenous</description>
    <arm_group_label>Arm C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with histologically or cytologically confirmed advanced metastatic or&#xD;
             unresectable colorectal cancer (CRC) that is relapsed, refractory, or progressive&#xD;
             following at least 2 prior systemic regimens in the metastatic setting.&#xD;
&#xD;
          -  Participants with an Eastern Cooperative Oncology Group (ECOG) of 0 - 1.&#xD;
&#xD;
          -  Participants with adequate hematologic, hepatic, and renal function.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine&#xD;
             based drug.&#xD;
&#xD;
        Additional Exclusion Criteria for the SC-006 and ABBV-181 Combination Treatment Regimen:&#xD;
&#xD;
          -  History of inflammatory bowel disease&#xD;
&#xD;
          -  Active autoimmune disease, with exception of psoriasis not requiring systemic&#xD;
             treatment, vitiligo, type 1 diabetes mellitus and hypothyroidism&#xD;
&#xD;
          -  History of primary immunodeficiency, allogenic bone marrow transplantation, solid&#xD;
             organ transplantation, or previous clinical diagnosis of tuberculosis&#xD;
&#xD;
          -  History of immune-mediated pneumonitis&#xD;
&#xD;
          -  Current or prior use of immunosuppressive medication within 14 days prior to the first&#xD;
             dose of 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>AbbVie Inc.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Highlands Oncology Group /ID# 201182</name>
      <address>
        <city>Fayetteville</city>
        <state>Arkansas</state>
        <zip>72703-4005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Los Angeles /ID# 160882</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Hospitals /ID# 167101</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109-5008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic - Rochester /ID# 160884</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 /ID# 160883</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center /ID# 160881</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065-6007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina BioOncology Institute /ID# 202712</name>
      <address>
        <city>Huntersville</city>
        <state>North Carolina</state>
        <zip>28078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma University /ID# 202713</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology-Nashville Centennial /ID# 160880</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203-1632</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>February 18, 2020</last_update_submitted>
  <last_update_submitted_qc>February 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Advanced colorectal cancer</keyword>
  <keyword>Cancer</keyword>
  <keyword>Metastatic colorectal cancer</keyword>
  <keyword>Unresectable colorectal cancer</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>
  </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/NCT03035279
org study id: M16-312
nct id: NCT03035279
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a multicenter, open-label, Phase 1 study of SC-006 given as a single agent and in
      combination with ABBV-181 in participants with advanced colorectal cancer (CRC), and consists
      of Part A (single agent SC-006 dose regimen finding), followed by Part B (single agent SC-006
      dose expansion), and Part C (SC-006 and ABBV-181 combination escalation and expansion). Part
      A (dose regimen finding) will involve dose escalation and possible dose interval modification
      to define the maximum tolerated dose (MTD) and/or recommended Part B dose and schedule. Part
      B (dose expansion) will enroll additional participants who will be treated with a study drug
      dose at or below the MTD determined in Part A. Part C is dose escalation of SC-006 and fixed
      dose of ABBV-181 in combination. Recommended dose cohort of SC-006 with ABBV-181 will be
      expanded.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with dose-limiting toxicities (DLT)
time frame: Minimum first cycle of dosing (21-day cycles)
description: DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
measure: Overall Survival (OS)
time frame: Approximately 2 years
description: OS is defined as the time from the participant's first dose date to death due to any cause.
measure: Progression Free Survival (PFS)
time frame: Approximately 2 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: Time to Cmax (Tmax) of SC-006
time frame: Approximately 1 year
description: Time to Cmax of SC-006
measure: Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-006
time frame: Approximately 1 year
description: Area under the plasma concentration-time curve within a dosing interval of SC-006
measure: Duration of Clinical Benefit (DOCB)
time frame: Approximately 2 years
description: DOCB is defined as the time from the initial partial response (PR), complete response (CR), or stable disease to disease progression.
measure: Objective Response Rate (ORR)
time frame: Approximately 2 years
description: ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR), as determined by Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
measure: Terminal half life (T1/2) of SC-006
time frame: Approximately 1 year
description: Terminal half life (T1/2) of SC-006
measure: Duration of response (DOR)
time frame: Approximately 2 years
description: DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression or death, whichever occurs first.
measure: Observed plasma concentrations at trough (Ctrough) of SC-006
time frame: Approximately 1 year
description: Observed plasma concentrations at trough of SC-006
measure: Clinical Benefit Rate (CBR) defined as CR, PR, or stable disease (SD)
time frame: Approximately 2 years
description: CBR is defined as the percentage of participants who achieve a best response of CR, PR, or stable disease (SD).
measure: Maximum observed serum concentration (Cmax) of SC-006
time frame: Approximately 1 year
description: Maximum observed serum concentration of SC-006
arm group label: Arm A
arm group type: Experimental
description: SC-006 Dose regimen finding
arm group label: Arm B
arm group type: Experimental
description: SC-006 Dose expansion
arm group label: Arm C
arm group type: Experimental
description: SC-006 and ABBV-181 Combination escalation and expansion
intervention type: Drug
intervention name: SC-006
description: Intravenous
arm group label: Arm A
arm group label: Arm B
arm group label: Arm C
intervention type: Drug
intervention name: ABBV-181
description: Intravenous
arm group label: Arm C
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: AbbVie Inc.
role: Study Director
affiliation: AbbVie
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: No