<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/NCT03809624</url>
  </required_header>
  <id_info>
    <org_study_id>Ph 1 Ph 2 INBRX-105</org_study_id>
    <nct_id>NCT03809624</nct_id>
  </id_info>
  <brief_title>Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer</brief_title>
  <acronym>PDL1x41BB</acronym>
  <official_title>An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Phase 1 / 2 Study of INBRX-105 and INBRX-105 in Combination With Pembrolizumab in Patients With Locally Advanced or Metastatic Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inhibrx, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inhibrx, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a first-in-human, open-label, nonrandomized, four-part trial to determine the safety&#xD;
      profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)&#xD;
      of INBRX-105 and INBRX-105 in combination with Pembrolizumab. INBRX-105, a next generation&#xD;
      bispecific antibody, targets the human programmed death-ligand 1 (PD-L1) receptor and the&#xD;
      human 4-1BB receptor. INBRX-105 provides localized conditional T-cell co-stimulation through&#xD;
      4-1BB agonism.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">August 2025</primary_completion_date>
  <phase>Phase 2</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>Frequency of adverse events of INBRX-105</measure>
    <time_frame>Up to 2-3 years</time_frame>
    <description>Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of adverse events of INBRX-105</measure>
    <time_frame>Up to 2-3 years</time_frame>
    <description>Severity of adverse events will be assessed and assigned by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-105</measure>
    <time_frame>Up to 2-3 years</time_frame>
    <description>The MTD and/or RP2D of INBRX-105 will be determined.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the serum concentration time curve (AUC) of INBRX-105</measure>
    <time_frame>Up to 2-3 years</time_frame>
    <description>Area under the serum concentration time curve (AUC) of INBRX-105 will be determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed serum concentration (Cmax) of INBRX-105</measure>
    <time_frame>Up to 2-3 years</time_frame>
    <description>Maximum observed serum concentration (Cmax) of INBRX-105 will be determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough observed serum concentration (Ctrough) of INBRX-105</measure>
    <time_frame>Up to 2-3 years</time_frame>
    <description>Trough observed serum concentration (Cmax) of INBRX-105 will be determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Cmax (Tmax) of INBRX-105</measure>
    <time_frame>Up to 2-3 years</time_frame>
    <description>Time to Cmax (Tmax) of INBRX-105 will be determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity of INBRX-105</measure>
    <time_frame>Up to 2-3 years</time_frame>
    <description>Frequency of anti-drug antibodies (ADA) against INBRX-105 will be determined.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Anti-tumor activity of INBRX-105</measure>
    <time_frame>Up to 2-3 years</time_frame>
    <description>Tumor response will be determined by immune Response Evaluation Criteria in Solid Tumors (iRECIST).</description>
  </other_outcome>
  <number_of_arms>11</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Metastatic Solid Tumors</condition>
  <condition>Non-small Cell Lung Cancer</condition>
  <condition>Melanoma</condition>
  <condition>Head and Neck Squamous Cell Carcinoma</condition>
  <condition>Gastric Adenocarcinoma</condition>
  <condition>Renal Cell Carcinoma</condition>
  <condition>Esophageal Adenocarcinoma</condition>
  <condition>Nasopharyngeal Carcinoma</condition>
  <condition>Oropharyngeal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Single Agent Escalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>INBRX-105 will be escalated in patients with locally advanced or metastatic solid tumors.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion Cohort Non-small Cell Lung Cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be treated with single-agent INBRX-105 at either the MTD or RP2D.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion Cohort Melanoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be treated with single-agent INBRX-105 at either the MTD or RP2D.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion Cohort PD-L1 Positive Basket</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with gastric or gastro-esophageal junction adenocarcinoma, renal cell carcinoma, and urothelial (transitional) cell carcinoma will be treated with single-agent INBRX-105 at either the MTD or RP2D.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion Cohort Nasopharyngeal or Oropharyngeal Carcinoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with head and neck squamous cell carcinoma (NPC or OPC) will be treated with single-agent INBRX-105 at either the MTD or RP2D.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>INBRX-105 Escalation in Combination with Pembrolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>INBRX-105 will be escalated in combination with Pembrolizumab in pateitns with locally advanced or metastatic solid tumors.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combination Expansion Cohort Non-small Cell Lung Cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CPI relapsed/refractory patients will be treated with INBRX-105 in combination with Pembrolizumab.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combination Expansion Cohort Melanoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CPI relapsed/refractory patients will be treated with INBRX-105 in combination with Pembrolizumab.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combination Expansion Cohort Cohort PD-L1 Positive Basket</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CPI-relapsed/refractory patients with head and neck squamous cell carcinoma, gastro-esophageal junction adenocarcinoma, renal cell carcinoma, and urothelial (transitional) cell carcinoma will be treated with INBRX-105 in combination with Pembrolizumab.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combination Expansion Cohort CPI Naive Non-small Cell Lung Cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CPI naive patients (PD-L1 IHC between 1 and 49%) will be treated with INBRX-105 in combination with Pembrolizumab.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combination Expansion Cohort CPI Naive HNSCC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CPI naive patients (PD-L1 IHC &gt;50%) will be treated with INBRX-105 in combination with Pembrolizumab.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INBRX-105 - PDL1x41BB antibody</intervention_name>
    <description>The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.</description>
    <arm_group_label>Combination Expansion Cohort CPI Naive HNSCC</arm_group_label>
    <arm_group_label>Combination Expansion Cohort CPI Naive Non-small Cell Lung Cancer</arm_group_label>
    <arm_group_label>Combination Expansion Cohort Cohort PD-L1 Positive Basket</arm_group_label>
    <arm_group_label>Combination Expansion Cohort Melanoma</arm_group_label>
    <arm_group_label>Combination Expansion Cohort Non-small Cell Lung Cancer</arm_group_label>
    <arm_group_label>Expansion Cohort Melanoma</arm_group_label>
    <arm_group_label>Expansion Cohort Nasopharyngeal or Oropharyngeal Carcinoma</arm_group_label>
    <arm_group_label>Expansion Cohort Non-small Cell Lung Cancer</arm_group_label>
    <arm_group_label>Expansion Cohort PD-L1 Positive Basket</arm_group_label>
    <arm_group_label>INBRX-105 Escalation in Combination with Pembrolizumab</arm_group_label>
    <arm_group_label>Single Agent Escalation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.</description>
    <arm_group_label>Combination Expansion Cohort CPI Naive Non-small Cell Lung Cancer</arm_group_label>
    <arm_group_label>Combination Expansion Cohort Cohort PD-L1 Positive Basket</arm_group_label>
    <arm_group_label>Combination Expansion Cohort Melanoma</arm_group_label>
    <arm_group_label>Combination Expansion Cohort Non-small Cell Lung Cancer</arm_group_label>
    <arm_group_label>INBRX-105 Escalation in Combination with Pembrolizumab</arm_group_label>
    <other_name>Keytruda</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parts 1 and 3 (escalation cohorts; completed): Patients with locally advanced or&#xD;
             metastatic non-resectable solid tumors, whose disease has progressed despite standard&#xD;
             therapy and for whom no further standard therapy exists.&#xD;
&#xD;
          -  Part 2 (expansion cohorts): Patients with non-small cell lung cancer, cutaneous&#xD;
             melanoma, head and neck squamous cell carcinoma or solid tumors amenable to paired&#xD;
             biopsies, with locally advanced or metastatic, non-resectable disease, which has&#xD;
             progressed despite standard therapy or for whom no standard or clinically acceptable&#xD;
             therapy exists.&#xD;
&#xD;
          -  Part 4 relapsed or refractory to CPI cohorts: NSCLC, cutaneous melanoma, HNSCC,&#xD;
             MSI/TMB-high or MMRd solid tumors&#xD;
&#xD;
          -  Part 4 CPI naive cohorts: locally advanced or metastatic, non-resectable NSCLC or&#xD;
             HNSCC&#xD;
&#xD;
          -  Refractory or relapsed to anti-PD-1 or anti-PD-L1, and anti-CTLA4 if applicable (NOTE:&#xD;
             For all tumor types with checkpoint inhibitor approvals) with exception of the&#xD;
             treatment naive NSCLC cohort.&#xD;
&#xD;
          -  PD-L1 positivity by immunohistochemistry (IHC): Parts 1 and 3 (escalation cohorts)&#xD;
             PD-L1 positivity is not required. Parts 2 and 4 (expansion cohorts): Combined Positive&#xD;
             Score (CPS) or Tumor Proportion Score (TPS) above certain thresholds as defined per&#xD;
             protocol.&#xD;
&#xD;
          -  Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior exposure to 4-1BB agonists.&#xD;
&#xD;
          -  Receipt of any investigational product or any approved anticancer drug(s) or&#xD;
             biological product(s) within 4 weeks prior to the first dose of study drug.&#xD;
             Exceptions: Hormone replacement therapy, testosterone, or oral contraceptives. NOTE:&#xD;
             Previous exposure to anti-PD-L1 checkpoint inhibitor requires a minimum washout period&#xD;
             of 24 weeks prior to the first dose of study drug.&#xD;
&#xD;
          -  Hematologic malignancies (e.g., ALL, AML, MDS, CLL, CML, NHL, Hodgkin lymphoma and&#xD;
             multiple myeloma).&#xD;
&#xD;
          -  Prior or concurrent malignancies. Exception: Subjects with a prior or concurrent&#xD;
             malignancy whose natural history or treatment does not have the potential to interfere&#xD;
             with the safety or efficacy assessments of INBRX-105.&#xD;
&#xD;
          -  Known or active primary central nervous system (CNS) tumors, leptomeningeal disease&#xD;
             and CNS metastases. Exception: Subjects with previously treated, asymptomatic, and&#xD;
             clinically stable CNS metastases may be allowed study entry if certain criteria apply.&#xD;
&#xD;
          -  Grade ≥ 3 immune-related adverse events (irAEs) or irAE that lead to discontinuation&#xD;
             of prior immunotherapy. Some exceptions as defined per protocol apply.&#xD;
&#xD;
          -  Active autoimmune disease or documented history of autoimmune disease that required&#xD;
             systemic steroids or other immunosuppressive medications. Certain exceptions as&#xD;
             defined in protocol apply.&#xD;
&#xD;
          -  Treatment with systemic immunosuppressive medications within 4 weeks prior to the&#xD;
             first dose of study drug. Certain exceptions as defined in protocol apply.&#xD;
&#xD;
          -  History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). Exceptions&#xD;
             as defined in protocol for expansion cohorts will apply.&#xD;
&#xD;
          -  History of hepatitis or cirrhosis (e.g., non-alcohol steatohepatitis, alcohol or&#xD;
             drug-related, autoimmune, hepatitis B, or hepatitis C). Exceptions as defined in&#xD;
             protocol for expansion cohorts will apply.&#xD;
&#xD;
          -  Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or&#xD;
             pneumonitis requiring treatment with steroids or other immunosuppressive medications.&#xD;
&#xD;
          -  Clinically significant cardiac condition, including myocardial infarction,&#xD;
             uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart&#xD;
             disease &lt; 3 months; left ventricular ejection fraction (LVEF) &lt; 50%; New York Heart&#xD;
             Association (NYHA) Class III or IV congestive heart failure; or uncontrolled&#xD;
             hypertension.&#xD;
&#xD;
          -  Active, hemodynamically significant pulmonary embolism within 3 months prior to&#xD;
             enrollment on this trial.&#xD;
&#xD;
          -  Major surgery within 4 weeks prior to enrollment on this trial.&#xD;
&#xD;
          -  Anti-infectious drug treatments (i.e., antibiotics) within 4 weeks prior to the first&#xD;
             dose of study drug.&#xD;
&#xD;
          -  Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC)&#xD;
             or bone marrow (BM) transplantation.&#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>Vasily Andrianov, MD</last_name>
    <role>Study Director</role>
    <affiliation>Inhibrx, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amanda Sweeney</last_name>
    <phone>858-500-7833</phone>
    <email>clinicaltrials@inhibrx.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kevin Bayer</last_name>
    <email>clinicaltrials@inhibrx.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>HonorHealth Research Institute</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mary Tatum</last_name>
      <phone>480-323-1594</phone>
      <email>mtatum@honorhealth.com</email>
    </contact>
    <investigator>
      <last_name>Tsai Frank, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>City of Hope at Irvine Lennar</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shamili Thiagarajan</last_name>
      <email>sthiagarajan@coh.org,</email>
    </contact>
    <investigator>
      <last_name>Erminia Massarelli, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>City of Hope</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shamili Thiagarajan</last_name>
      <phone>626-218-0979</phone>
      <email>sthiagarajan@coh.org</email>
    </contact>
    <investigator>
      <last_name>Erminia Massarelli, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Valkyrie Clinical Trials</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90069</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Myo Zaw</last_name>
      <phone>310-905-6791</phone>
      <email>myo.zaw@valkyrieclinicaltrials.com</email>
    </contact>
    <investigator>
      <last_name>David Berz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Dimitrios Colevas, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Colorado Denver</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Emory University - Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Suzanne Scott</last_name>
      <phone>404-778-4083</phone>
      <email>suzanne.e.scott@emory.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Goshen Center for Cancer Care</name>
      <address>
        <city>Goshen</city>
        <state>Indiana</state>
        <zip>46526</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Chelsey Formato</last_name>
      <email>cformato@goshenhealth.com</email>
    </contact>
    <investigator>
      <last_name>Ebenezer Kio, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Norton Cancer Center</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rebecca Gash, RN</last_name>
      <phone>502-629-2500</phone>
      <phone_ext>19535</phone_ext>
      <email>rebecca.gash@nortonhealthcare.org</email>
    </contact>
    <investigator>
      <last_name>John Hamm, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrew Lorusso, MD</last_name>
      <email>ajlorusso@mgh.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Jong Chul Park, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>START Midwest</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49546</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julie Burns</last_name>
      <phone>616-954-5559</phone>
      <email>julie.burns@startmidwest.com</email>
    </contact>
    <investigator>
      <last_name>Manish Sharma, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Douglas Adkins, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nebraska Cancer Specialists - Grand Island</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ralph Hauke, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nebraska Cancer Specialists</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Josh Settlemire</last_name>
      <phone>531-329-3651</phone>
      <email>Jsettlemire@nebraskacancer.com</email>
    </contact>
    <investigator>
      <last_name>Ralph Hauke, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence Cancer Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alaina Randerson, RN</last_name>
      <phone>503-215-7192</phone>
      <email>alaina.randerson@providence.org</email>
    </contact>
    <investigator>
      <last_name>Rachel Sanborn, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Abramson Cancer Center - University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifr Louie</last_name>
      <email>jennifer.louie2@pennmedicine.upenn.edu</email>
    </contact>
    <investigator>
      <last_name>Naomi Hass, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Abramson Cancer Center at Pennsylvania Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pavit Singh</last_name>
      <email>pavit.singh@pennmedicine.upenn.edu;</email>
    </contact>
    <investigator>
      <last_name>Naomi Hass, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Jennifer Choe, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna Lui</last_name>
      <phone>713-794-1751</phone>
      <email>ALui@mdanderson.org</email>
    </contact>
    <investigator>
      <last_name>David Hong, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>New Experimental Therapeutics of San Antonio - NEXT Oncology</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>START Mountain Region</name>
      <address>
        <city>West Valley City</city>
        <state>Utah</state>
        <zip>84119</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marianne Herndon</last_name>
      <phone>801-590-8520</phone>
      <phone_ext>1515</phone_ext>
      <email>marianne.herndon@startthecure.com</email>
    </contact>
    <investigator>
      <last_name>Justin Call, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Janice Alcaide</last_name>
      <email>janice.alcaide@usoncology.com</email>
    </contact>
    <investigator>
      <last_name>Alexander Spira, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwest Medical Specialties, PLLC</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Jorge Chaves, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>August 29, 2023</last_update_submitted>
  <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Phase 2</keyword>
  <keyword>Phase 2 Clinical Trial</keyword>
  <keyword>Solid Tumors</keyword>
  <keyword>Lung Cancer</keyword>
  <keyword>Melanoma</keyword>
  <keyword>Head and Neck Cancer</keyword>
  <keyword>Stomach Cancer</keyword>
  <keyword>Gastric Cancer</keyword>
  <keyword>Kidney Cancer</keyword>
  <keyword>Renal cell carcinoma</keyword>
  <keyword>Renal Cancer</keyword>
  <keyword>Urothelial Carcinoma</keyword>
  <keyword>PDL1</keyword>
  <keyword>41BB</keyword>
  <keyword>PD-L1</keyword>
  <keyword>4-1BB</keyword>
  <keyword>Pembrolizumab</keyword>
  <keyword>Keytruda</keyword>
  <keyword>Nasopharyngeal carcinoma</keyword>
  <keyword>Oropharyngeal carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Melanoma</mesh_term>
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
    <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pembrolizumab</mesh_term>
    <mesh_term>Antibodies</mesh_term>
  </intervention_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/NCT03809624
org study id: Ph 1 Ph 2 INBRX-105
nct id: NCT03809624
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a first-in-human, open-label, nonrandomized, four-part trial to determine the safety
      profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
      of INBRX-105 and INBRX-105 in combination with Pembrolizumab. INBRX-105, a next generation
      bispecific antibody, targets the human programmed death-ligand 1 (PD-L1) receptor and the
      human 4-1BB receptor. INBRX-105 provides localized conditional T-cell co-stimulation through
      4-1BB agonism.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Frequency of adverse events of INBRX-105
time frame: Up to 2-3 years
description: Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
measure: Severity of adverse events of INBRX-105
time frame: Up to 2-3 years
description: Severity of adverse events will be assessed and assigned by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
measure: Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-105
time frame: Up to 2-3 years
description: The MTD and/or RP2D of INBRX-105 will be determined.
measure: Area under the serum concentration time curve (AUC) of INBRX-105
time frame: Up to 2-3 years
description: Area under the serum concentration time curve (AUC) of INBRX-105 will be determined.
measure: Maximum observed serum concentration (Cmax) of INBRX-105
time frame: Up to 2-3 years
description: Maximum observed serum concentration (Cmax) of INBRX-105 will be determined.
measure: Trough observed serum concentration (Ctrough) of INBRX-105
time frame: Up to 2-3 years
description: Trough observed serum concentration (Cmax) of INBRX-105 will be determined.
measure: Time to Cmax (Tmax) of INBRX-105
time frame: Up to 2-3 years
description: Time to Cmax (Tmax) of INBRX-105 will be determined.
measure: Immunogenicity of INBRX-105
time frame: Up to 2-3 years
description: Frequency of anti-drug antibodies (ADA) against INBRX-105 will be determined.
measure: Anti-tumor activity of INBRX-105
time frame: Up to 2-3 years
description: Tumor response will be determined by immune Response Evaluation Criteria in Solid Tumors (iRECIST).
arm group label: Single Agent Escalation
arm group type: Experimental
description: INBRX-105 will be escalated in patients with locally advanced or metastatic solid tumors.
arm group label: Expansion Cohort Non-small Cell Lung Cancer
arm group type: Experimental
description: Patients will be treated with single-agent INBRX-105 at either the MTD or RP2D.
arm group label: Expansion Cohort Melanoma
arm group type: Experimental
description: Patients will be treated with single-agent INBRX-105 at either the MTD or RP2D.
arm group label: Expansion Cohort PD-L1 Positive Basket
arm group type: Experimental
description: Patients with gastric or gastro-esophageal junction adenocarcinoma, renal cell carcinoma, and urothelial (transitional) cell carcinoma will be treated with single-agent INBRX-105 at either the MTD or RP2D.
arm group label: Expansion Cohort Nasopharyngeal or Oropharyngeal Carcinoma
arm group type: Experimental
description: Patients with head and neck squamous cell carcinoma (NPC or OPC) will be treated with single-agent INBRX-105 at either the MTD or RP2D.
arm group label: INBRX-105 Escalation in Combination with Pembrolizumab
arm group type: Experimental
description: INBRX-105 will be escalated in combination with Pembrolizumab in pateitns with locally advanced or metastatic solid tumors.
arm group label: Combination Expansion Cohort Non-small Cell Lung Cancer
arm group type: Experimental
description: CPI relapsed/refractory patients will be treated with INBRX-105 in combination with Pembrolizumab.
arm group label: Combination Expansion Cohort Melanoma
arm group type: Experimental
description: CPI relapsed/refractory patients will be treated with INBRX-105 in combination with Pembrolizumab.
arm group label: Combination Expansion Cohort Cohort PD-L1 Positive Basket
arm group type: Experimental
description: CPI-relapsed/refractory patients with head and neck squamous cell carcinoma, gastro-esophageal junction adenocarcinoma, renal cell carcinoma, and urothelial (transitional) cell carcinoma will be treated with INBRX-105 in combination with Pembrolizumab.
arm group label: Combination Expansion Cohort CPI Naive Non-small Cell Lung Cancer
arm group type: Experimental
description: CPI naive patients (PD-L1 IHC between 1 and 49%) will be treated with INBRX-105 in combination with Pembrolizumab.
arm group label: Combination Expansion Cohort CPI Naive HNSCC
arm group type: Experimental
description: CPI naive patients (PD-L1 IHC >50%) will be treated with INBRX-105 in combination with Pembrolizumab.
intervention type: Drug
intervention name: INBRX-105 - PDL1x41BB antibody
description: The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.
arm group label: Combination Expansion Cohort CPI Naive HNSCC
arm group label: Combination Expansion Cohort CPI Naive Non-small Cell Lung Cancer
arm group label: Combination Expansion Cohort Cohort PD-L1 Positive Basket
arm group label: Combination Expansion Cohort Melanoma
arm group label: Combination Expansion Cohort Non-small Cell Lung Cancer
arm group label: Expansion Cohort Melanoma
arm group label: Expansion Cohort Nasopharyngeal or Oropharyngeal Carcinoma
arm group label: Expansion Cohort Non-small Cell Lung Cancer
arm group label: Expansion Cohort PD-L1 Positive Basket
arm group label: INBRX-105 Escalation in Combination with Pembrolizumab
arm group label: Single Agent Escalation
intervention type: Drug
intervention name: Pembrolizumab
description: Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.
arm group label: Combination Expansion Cohort CPI Naive Non-small Cell Lung Cancer
arm group label: Combination Expansion Cohort Cohort PD-L1 Positive Basket
arm group label: Combination Expansion Cohort Melanoma
arm group label: Combination Expansion Cohort Non-small Cell Lung Cancer
arm group label: INBRX-105 Escalation in Combination with Pembrolizumab
other name: Keytruda
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vasily Andrianov, MD
role: Study Director
affiliation: Inhibrx, Inc.
last name: Amanda Sweeney
phone: 858-500-7833
email: clinicaltrials@inhibrx.com
last name: Kevin Bayer
email: clinicaltrials@inhibrx.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Melanoma
mesh term: Adenocarcinoma
mesh term: Carcinoma, Renal Cell
mesh term: Nasopharyngeal Carcinoma
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Pembrolizumab
mesh term: Antibodies
sharing ipd: No