<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/NCT02988960</url>
  </required_header>
  <id_info>
    <org_study_id>M15-862</org_study_id>
    <secondary_id>2016-002219-16</secondary_id>
    <nct_id>NCT02988960</nct_id>
  </id_info>
  <brief_title>A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors</brief_title>
  <official_title>A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-927 and ABBV-181, an Immunotherapy, in Subjects With Advanced Solid Tumors</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 dose-escalation study designed to evaluate the safety, pharmacokinetics, and&#xD;
      pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or&#xD;
      recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as&#xD;
      combination therapy with ABBV-181 in participants with advanced solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 22, 2017</start_date>
  <completion_date type="Anticipated">February 10, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 10, 2024</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>Maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>The MTD and the RPTD of ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 will be determined during the dose escalation phase of the study. Once the RPTD has been determined, the dose expansion portion will begin.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Cmax (Tmax) of ABBV-927</measure>
    <time_frame>Up to 12 weeks after participant's first dose</time_frame>
    <description>Time to Cmax (Tmax) of ABBV-927.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed serum concentration (Cmax) of ABBV-927</measure>
    <time_frame>Up to 12 weeks after participant's first dose</time_frame>
    <description>Maximum observed serum concentration (Cmax) of ABBV-927.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal-Phase Elimination Rate Constant (β) of ABBV-927</measure>
    <time_frame>Up to 12 weeks after participant's first dose</time_frame>
    <description>Terminal-phase elimination rate constant (β)of ABBV-927.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal half-life (t1/2) of ABBV-927</measure>
    <time_frame>Up to 4 weeks after participant's first dose</time_frame>
    <description>Terminal half-life (t1/2) of ABBV-927.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the serum concentration-time curve (AUCt) of ABBV-927</measure>
    <time_frame>Up to 12 weeks after participant's first dose</time_frame>
    <description>Area under the serum concentration-time curve from time zero to the time of last measurable concentration (AUCt) of ABBV-927.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Cmax (Tmax) of ABBV-181</measure>
    <time_frame>Up to 12 weeks after participant's first dose</time_frame>
    <description>Time to Cmax (Tmax) of ABBV-181.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed serum concentration (Cmax) of ABBV-181</measure>
    <time_frame>Up to 12 weeks after participant's first dose</time_frame>
    <description>Maximum observed serum concentration (Cmax) of ABBV-181.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal-Phase Elimination Rate Constant (β) of ABBV-181</measure>
    <time_frame>Up to 12 weeks after participant's first dose</time_frame>
    <description>Terminal-phase elimination rate constant (β)of ABBV-181.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal half-life (t1/2) of ABBV-181</measure>
    <time_frame>Up to 4 weeks after participant's first dose</time_frame>
    <description>Terminal half-life (t1/2) of ABBV-181.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the serum concentration-time curve (AUCt) of ABBV-181</measure>
    <time_frame>Up to 12 weeks after participant's first dose</time_frame>
    <description>Area under the serum concentration-time curve from time zero to the time of last measurable concentration (AUCt) of ABBV-181.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>Up to 30 days after and up to 24-month of treatment period</time_frame>
    <description>An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical benefit rate (CBR, defined as the percentage of participants with a confirmed partial, complete response, or stable disease for at least 24 weeks to the treatment)</measure>
    <time_frame>Up to 30 days after and up to 24-month of treatment period</time_frame>
    <description>CBR defined as the proportion of subjects with a confirmed partial response (PR), complete response (CR), or stable disease for at least 24 weeks to the treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of objective response (DOR)</measure>
    <time_frame>Up to 30 days after and up to 24-month of treatment period</time_frame>
    <description>DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>Up to 30 days after and up to 24-month of treatment period</time_frame>
    <description>ORR is defined as the proportion of participants with a confirmed partial or complete response to the treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>Up to 30 days after and up to 24-month of treatment period</time_frame>
    <description>PFS time is defined as the time from the first dose of ABBV-927 to disease progression or death, whichever occurs first.</description>
  </secondary_outcome>
  <number_of_arms>9</number_of_arms>
  <enrollment type="Actual">163</enrollment>
  <condition>Advanced Solid Tumors Cancer</condition>
  <arm_group>
    <arm_group_label>Escalating Arm 1: ABBV-927</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Escalating Arm 2: ABBV-927</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with solid tumors will receive escalating intratumoral (IT) doses of ABBV-927.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Escalating Arm 3: ABBV-927+ABBV-181</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with Non-Small Cell Lung Cancer (NSCLC) will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Escalating Arm 4: ABBV-927+ABBV-181</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with Head and Neck Squamous Cell Carcinoma (HNSCC) will receive escalating IT doses of ABBV-927 and IV doses of ABBV-181.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Escalating Arm 5 (Japan): ABBV-927</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Escalating Arm 6 (Japan): ABBV-927+ABBV-181</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with solid tumors will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion Arm A: ABBV-927</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Additional participants with HNSCC or NSCLC will receive intravenous (IV) doses of ABBV-927.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion Arm B: ABBV-927+ABBV-181</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Additional participants with HNSCC will receive IT doses of ABBV-927 and IV doses of ABBV-181.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion Arm C: ABBV-927+ABBV-181</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Additional participants with NSCLC will receive IV doses of ABBV-927 and IV doses of ABBV-181.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABBV-927</intervention_name>
    <description>Intravenous</description>
    <arm_group_label>Escalating Arm 1: ABBV-927</arm_group_label>
    <arm_group_label>Escalating Arm 3: ABBV-927+ABBV-181</arm_group_label>
    <arm_group_label>Escalating Arm 5 (Japan): ABBV-927</arm_group_label>
    <arm_group_label>Escalating Arm 6 (Japan): ABBV-927+ABBV-181</arm_group_label>
    <arm_group_label>Expansion Arm A: ABBV-927</arm_group_label>
    <arm_group_label>Expansion Arm C: ABBV-927+ABBV-181</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABBV-927</intervention_name>
    <description>Intratumoral</description>
    <arm_group_label>Escalating Arm 2: ABBV-927</arm_group_label>
    <arm_group_label>Escalating Arm 4: ABBV-927+ABBV-181</arm_group_label>
    <arm_group_label>Expansion Arm B: ABBV-927+ABBV-181</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABBV-181</intervention_name>
    <description>Intravenous</description>
    <arm_group_label>Escalating Arm 3: ABBV-927+ABBV-181</arm_group_label>
    <arm_group_label>Escalating Arm 4: ABBV-927+ABBV-181</arm_group_label>
    <arm_group_label>Escalating Arm 6 (Japan): ABBV-927+ABBV-181</arm_group_label>
    <arm_group_label>Expansion Arm B: ABBV-927+ABBV-181</arm_group_label>
    <arm_group_label>Expansion Arm C: ABBV-927+ABBV-181</arm_group_label>
    <other_name>Budigalimab</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0&#xD;
             to 1.&#xD;
&#xD;
          -  Participants have adequate bone marrow, kidney and liver function.&#xD;
&#xD;
          -  Participants with a history of chronic heart failure or significant cardiovascular&#xD;
             disease must have an echocardiogram or multigated acquisition scan indicating left&#xD;
             ventricular ejection fraction greater than or equal to 45% within 28 days prior to the&#xD;
             first dose of study drug.&#xD;
&#xD;
          -  Participants must have creatinine clearance greater than or equal to 50 mL/min as&#xD;
             measured by 24-hour urine or estimated by the Cockcroft-Gault formula.&#xD;
&#xD;
          -  Participants must have total bilirubin less than or equal to 1.5 times the upper limit&#xD;
             of normal (ULN), and aspartate aminotransferase and alanine aminotransferase less than&#xD;
             or equal to 2.5 times ULN.&#xD;
&#xD;
          -  Participants in all monotherapy arms must have an advanced solid tumor that has&#xD;
             progressed on standard therapies known to provide clinical benefit or the participants&#xD;
             are intolerant to such therapies.&#xD;
&#xD;
          -  Participants in all combination therapy arms must have recurrent or metastatic HNSCC&#xD;
             or NSCLC and previously received platinum-based therapy and progressed either during&#xD;
             or after anti-programmed death ligand 1 (PDL1)-based therapy. In addition,&#xD;
             participants must have received only one prior immunotherapy.&#xD;
&#xD;
          -  The Sponsor may decide to limit the specific tumor types selected or treatment&#xD;
             settings for specific arms based on evidence gathered.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant must not have an active or prior documented autoimmune disease in the last&#xD;
             2 years.&#xD;
&#xD;
          -  Participant must not have current or prior use of immunosuppressive medication within&#xD;
             14 days prior to the first dose (with certain exceptions).&#xD;
&#xD;
          -  Participant must not have a history of primary immunodeficiency, bone marrow&#xD;
             transplantation, chronic lymphocytic leukemia, solid organ transplantation, previous&#xD;
             clinical diagnosis of tuberculosis, inflammatory bowel disease, interstitial lung&#xD;
             disease, or immune-mediated pneumonitis.&#xD;
&#xD;
          -  Participant must not have a history of clinically significant uncontrolled&#xD;
             condition(s) including but not limited to the following: uncontrolled hypertension;&#xD;
             symptomatic congestive heart failure; unstable angina pectoris or cardiac arrhythmia&#xD;
             including atrial fibrillation.&#xD;
&#xD;
          -  Participant must not have a history of coagulopathy or a platelet disorder associated&#xD;
             with significant clinical risk of thromboembolic event in the judgement of the&#xD;
             investigator, or major thromboembolic event within 6 months prior to the first dose of&#xD;
             study treatment.&#xD;
&#xD;
          -  Participant must not have a prior grade greater than or equal to 3 immune-mediated&#xD;
             neurotoxicity or pneumonitis while receiving immunotherapy.&#xD;
&#xD;
          -  Participant must not have a known uncontrolled malignancy of the central nervous&#xD;
             system.&#xD;
&#xD;
          -  Participants in all combination therapy arms must not have a history of exposure to an&#xD;
             immunotherapy experiencing an immune-mediated adverse event that required permanent&#xD;
             discontinuation of the immunotherapy.&#xD;
&#xD;
          -  Female participants must not be pregnant, breastfeeding or considering becoming&#xD;
             pregnant during the study or for at least 3 or 5 months (for monotherapy and&#xD;
             combination therapy participants, respectively) after the last dose of study drug.&#xD;
&#xD;
          -  Male participants must not be considering fathering a child or donating sperm during&#xD;
             the study or for at least 3 or 5 months (for monotherapy and combination therapy&#xD;
             participants, respectively) after the last dose of study drug.&#xD;
&#xD;
          -  Participant is judged by the investigator to have evidence of hemolysis.&#xD;
&#xD;
          -  For Japan only, participants with a history of interstitial lung disease (pneumonitis)&#xD;
             or current interstitial lung disease (pneumonitis).&#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>The Angeles Clinic and Researc /ID# 156324</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Chicago Medical Center /ID# 155264</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637-1443</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital /ID# 155267</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina BioOncology Institute /ID# 155265</name>
      <address>
        <city>Huntersville</city>
        <state>North Carolina</state>
        <zip>28078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology-Nashville Centennial /ID# 158654</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203-1632</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center /ID# 155263</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists - Fairfax /ID# 155266</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peninsula Oncology Centre /ID# 164372</name>
      <address>
        <city>Frankston</city>
        <state>Victoria</state>
        <zip>3199</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Health /ID# 171189</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre /ID# 200819</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Bergonie /ID# 162665</name>
      <address>
        <city>Bordeaux</city>
        <state>Gironde</state>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_Institut Regional du Cancer /ID# 163609</name>
      <address>
        <city>Montpellier CEDEX 5</city>
        <state>Herault</state>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Leon Berard /ID# 162663</name>
      <address>
        <city>Lyon CEDEX 08</city>
        <state>Rhone</state>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy /ID# 162666</name>
      <address>
        <city>Villejuif Cedex</city>
        <state>Val-de-Marne</state>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital East /ID# 216870</name>
      <address>
        <city>Kashiwa-shi</city>
        <state>Chiba</state>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital /ID# 217758</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yonsei University Health System Severance Hospital /ID# 166292</name>
      <address>
        <city>Seoul</city>
        <state>Seoul Teugbyeolsi</state>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital /ID# 166291</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro, Majadahonda /ID# 200129</name>
      <address>
        <city>Majadahonda</city>
        <state>Madrid</state>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundacion Jimenez Diaz /ID# 200128</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario HM Sanchinarro /ID# 200127</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario y Politecnico La Fe /ID# 200975</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>France</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>February 13, 2023</last_update_submitted>
  <last_update_submitted_qc>February 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non-small cell lung cancer (NSCLC)</keyword>
  <keyword>Squamous cell carcinoma of the head and neck (SCCHN)</keyword>
  <keyword>Advanced solid tumor</keyword>
  <keyword>Cancer</keyword>
  <keyword>Pancreatic adenocarcinoma</keyword>
  <keyword>Cutaneous melanoma</keyword>
  <keyword>ABBV-927</keyword>
  <keyword>ABBV-181</keyword>
  <keyword>Budigalimab</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>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/NCT02988960
org study id: M15-862
secondary id: 2016-002219-16
nct id: NCT02988960
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and
      pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or
      recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as
      combination therapy with ABBV-181 in participants with advanced solid tumors.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181
time frame: Up to 8 weeks
description: The MTD and the RPTD of ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 will be determined during the dose escalation phase of the study. Once the RPTD has been determined, the dose expansion portion will begin.
measure: Time to Cmax (Tmax) of ABBV-927
time frame: Up to 12 weeks after participant's first dose
description: Time to Cmax (Tmax) of ABBV-927.
measure: Maximum observed serum concentration (Cmax) of ABBV-927
time frame: Up to 12 weeks after participant's first dose
description: Maximum observed serum concentration (Cmax) of ABBV-927.
measure: Terminal-Phase Elimination Rate Constant (β) of ABBV-927
time frame: Up to 12 weeks after participant's first dose
description: Terminal-phase elimination rate constant (β)of ABBV-927.
measure: Terminal half-life (t1/2) of ABBV-927
time frame: Up to 4 weeks after participant's first dose
description: Terminal half-life (t1/2) of ABBV-927.
measure: Area under the serum concentration-time curve (AUCt) of ABBV-927
time frame: Up to 12 weeks after participant's first dose
description: Area under the serum concentration-time curve from time zero to the time of last measurable concentration (AUCt) of ABBV-927.
measure: Time to Cmax (Tmax) of ABBV-181
time frame: Up to 12 weeks after participant's first dose
description: Time to Cmax (Tmax) of ABBV-181.
measure: Maximum observed serum concentration (Cmax) of ABBV-181
time frame: Up to 12 weeks after participant's first dose
description: Maximum observed serum concentration (Cmax) of ABBV-181.
measure: Terminal-Phase Elimination Rate Constant (β) of ABBV-181
time frame: Up to 12 weeks after participant's first dose
description: Terminal-phase elimination rate constant (β)of ABBV-181.
measure: Terminal half-life (t1/2) of ABBV-181
time frame: Up to 4 weeks after participant's first dose
description: Terminal half-life (t1/2) of ABBV-181.
measure: Area under the serum concentration-time curve (AUCt) of ABBV-181
time frame: Up to 12 weeks after participant's first dose
description: Area under the serum concentration-time curve from time zero to the time of last measurable concentration (AUCt) of ABBV-181.
measure: Number of Participants with Adverse Events
time frame: Up to 30 days after and up to 24-month of treatment period
description: An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
measure: Clinical benefit rate (CBR, defined as the percentage of participants with a confirmed partial, complete response, or stable disease for at least 24 weeks to the treatment)
time frame: Up to 30 days after and up to 24-month of treatment period
description: CBR defined as the proportion of subjects with a confirmed partial response (PR), complete response (CR), or stable disease for at least 24 weeks to the treatment.
measure: Duration of objective response (DOR)
time frame: Up to 30 days after and up to 24-month of treatment period
description: DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first.
measure: Objective response rate (ORR)
time frame: Up to 30 days after and up to 24-month of treatment period
description: ORR is defined as the proportion of participants with a confirmed partial or complete response to the treatment.
measure: Progression-free survival (PFS)
time frame: Up to 30 days after and up to 24-month of treatment period
description: PFS time is defined as the time from the first dose of ABBV-927 to disease progression or death, whichever occurs first.
arm group label: Escalating Arm 1: ABBV-927
arm group type: Experimental
description: Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927.
arm group label: Escalating Arm 2: ABBV-927
arm group type: Experimental
description: Participants with solid tumors will receive escalating intratumoral (IT) doses of ABBV-927.
arm group label: Escalating Arm 3: ABBV-927+ABBV-181
arm group type: Experimental
description: Participants with Non-Small Cell Lung Cancer (NSCLC) will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181.
arm group label: Escalating Arm 4: ABBV-927+ABBV-181
arm group type: Experimental
description: Participants with Head and Neck Squamous Cell Carcinoma (HNSCC) will receive escalating IT doses of ABBV-927 and IV doses of ABBV-181.
arm group label: Escalating Arm 5 (Japan): ABBV-927
arm group type: Experimental
description: Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927.
arm group label: Escalating Arm 6 (Japan): ABBV-927+ABBV-181
arm group type: Experimental
description: Participants with solid tumors will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181.
arm group label: Expansion Arm A: ABBV-927
arm group type: Experimental
description: Additional participants with HNSCC or NSCLC will receive intravenous (IV) doses of ABBV-927.
arm group label: Expansion Arm B: ABBV-927+ABBV-181
arm group type: Experimental
description: Additional participants with HNSCC will receive IT doses of ABBV-927 and IV doses of ABBV-181.
arm group label: Expansion Arm C: ABBV-927+ABBV-181
arm group type: Experimental
description: Additional participants with NSCLC will receive IV doses of ABBV-927 and IV doses of ABBV-181.
intervention type: Drug
intervention name: ABBV-927
description: Intravenous
arm group label: Escalating Arm 1: ABBV-927
arm group label: Escalating Arm 3: ABBV-927+ABBV-181
arm group label: Escalating Arm 5 (Japan): ABBV-927
arm group label: Escalating Arm 6 (Japan): ABBV-927+ABBV-181
arm group label: Expansion Arm A: ABBV-927
arm group label: Expansion Arm C: ABBV-927+ABBV-181
intervention type: Drug
intervention name: ABBV-927
description: Intratumoral
arm group label: Escalating Arm 2: ABBV-927
arm group label: Escalating Arm 4: ABBV-927+ABBV-181
arm group label: Expansion Arm B: ABBV-927+ABBV-181
intervention type: Drug
intervention name: ABBV-181
description: Intravenous
arm group label: Escalating Arm 3: ABBV-927+ABBV-181
arm group label: Escalating Arm 4: ABBV-927+ABBV-181
arm group label: Escalating Arm 6 (Japan): ABBV-927+ABBV-181
arm group label: Expansion Arm B: ABBV-927+ABBV-181
arm group label: Expansion Arm C: ABBV-927+ABBV-181
other name: Budigalimab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
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country: Australia
country: Canada
country: France
country: Japan
country: Korea, Republic of
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No