<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/NCT04408599</url>
  </required_header>
  <id_info>
    <org_study_id>NC410-01</org_study_id>
    <nct_id>NCT04408599</nct_id>
  </id_info>
  <brief_title>A Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors</brief_title>
  <official_title>A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NextCure, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NextCure, 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 research study is studying a new drug, NC410, as a possible treatment for advanced or&#xD;
      metastatic solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Upon completion of the Phase 1 portion of the NC410 monotherapy trial, NextCure focused efforts&#xD;
    on a combination trial of NC410 in solid tumors.&#xD;
  </why_stopped>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Actual">July 7, 2023</completion_date>
  <primary_completion_date type="Actual">July 7, 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>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 treatment-emergent adverse events as assessed by CTCAE v5.0</measure>
    <time_frame>up to 14 months</time_frame>
    <description>Frequency, duration, and severity of treatment-emergent adverse events (AEs)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Define a maximum tolerated dose (MTD) or pharmacologically active dose (PAD)</measure>
    <time_frame>28 days</time_frame>
    <description>A 3 + 3 design will be utilized to determine the MTD of NC410</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate per RECIST</measure>
    <time_frame>14 months</time_frame>
    <description>Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and modified RECIST (mRECIST) v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response per RECIST</measure>
    <time_frame>14 months</time_frame>
    <description>Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and modified RECIST (mRECIST) v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate per RECIST</measure>
    <time_frame>14 months</time_frame>
    <description>Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and modified RECIST (mRECIST) v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration (Cmax) of NC410</measure>
    <time_frame>14 weeks</time_frame>
    <description>To evaluate the Maximum Plasma Concentration (Cmax) of NC410</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Advanced or Metastatic Solid Tumors</condition>
  <condition>Ovarian Cancer</condition>
  <condition>Gastric Cancer</condition>
  <condition>Colo-rectal Cancer</condition>
  <arm_group>
    <arm_group_label>NC410</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NC410 for IV infusion of various dose strengths administered in 14 day dosing cycles</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NC410</intervention_name>
    <description>NC410 is an experimental antibody drug that may make the immune response more active against cancer</description>
    <arm_group_label>NC410</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged 18 or older.&#xD;
&#xD;
          -  Willingness to provide written informed consent for the study.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.&#xD;
&#xD;
          -  Locally advanced or metastatic disease; locally advanced disease must not be amenable&#xD;
             to resection with curative intent.&#xD;
&#xD;
          -  Subjects who have disease progression after treatment with available therapies that&#xD;
             are known to confer clinical benefit, or who are intolerant to treatment, or who&#xD;
             refuse standard treatment. Note: There is no limit to the number of prior treatment&#xD;
             regimens.&#xD;
&#xD;
          -  Presence of measurable disease based on RECIST v1.1. Tumor lesions situated in a&#xD;
             previously irradiated area, or in an area subjected to other locoregional therapy, are&#xD;
             not considered measurable unless there has been demonstrated progression in the&#xD;
             lesion.&#xD;
&#xD;
          -  After dose escalation, subject must be willing to undergo pretreatment and&#xD;
             on-treatment tumor biopsies (core or excisional). Note: A baseline biopsy obtained for&#xD;
             other purposes (i.e., not an NC410-01 study procedure) before signing consent may be&#xD;
             utilized if the subject has not had any intervening systemic therapy from the time of&#xD;
             the biopsy to the start of treatment with the medical monitor's approval.&#xD;
&#xD;
          -  Female subjects of childbearing potential (defined as women who have not undergone&#xD;
             surgical sterilization with a hysterectomy and/or bilateral oophorectomy and are not&#xD;
             postmenopausal, defined as ≥ 12 months of amenorrhea) must have a negative serum&#xD;
             pregnancy test at screening. All female and male subjects of childbearing potential&#xD;
             must agree to take appropriate precautions to avoid pregnancy or fathering children&#xD;
             (with at least 99% certainty) from screening through 60 days after the last dose of&#xD;
             study drug.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to comprehend or unwilling to sign the Informed Consent Form.&#xD;
&#xD;
          -  Screening laboratory values of:&#xD;
&#xD;
               1. Absolute neutrophil count &lt; 1.5 × 10^9/L&#xD;
&#xD;
               2. Platelets &lt; 100 × 10^9/L&#xD;
&#xD;
               3. Hemoglobin &lt; 9 g/dL or &lt; 5.6 mmol/L&#xD;
&#xD;
               4. Serum creatinine &gt; 1.5 × institutional upper limit of normal (ULN)&#xD;
&#xD;
               5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 2.5 × ULN&#xD;
&#xD;
               6. Total bilirubin ≥ 1.5 × ULN unless conjugated bilirubin ≤ ULN (conjugated&#xD;
                  bilirubin only needs to be tested if total bilirubin exceeds ULN). If there is no&#xD;
                  institutional ULN, then direct bilirubin must be &lt; 40% of total bilirubin.&#xD;
&#xD;
               7. International normalized ratio (INR) or prothrombin time (PT) &gt; 1.5 × ULN&#xD;
&#xD;
               8. Activated partial thromboplastin time (aPTT) &gt; 1.5 × ULN&#xD;
&#xD;
          -  Transfusion of blood products (including platelets or red blood cells) or&#xD;
             administration of colony-stimulating factors (including granulocyte colony-stimulating&#xD;
             factor, granulocyte macrophage colony-stimulating factor, or recombinant&#xD;
             erythropoietin) within 14 days before the first administration of study drug.&#xD;
&#xD;
          -  Receipt of anticancer medications or investigational drugs within the following&#xD;
             intervals before the first administration of study drug:&#xD;
&#xD;
               1. ≤ 14 days for chemotherapy, targeted small molecule therapy, or radiation&#xD;
                  therapy. Subjects must also not require chronic use of corticosteroids and must&#xD;
                  not have had radiation pneumonitis because of a treatment. A 1-week washout is&#xD;
                  permitted for palliative radiation to non-central nervous system (CNS) disease&#xD;
                  with medical monitor approval. Note: Bisphosphonates and denosumab are permitted&#xD;
                  medications.&#xD;
&#xD;
               2. ≤ 28 days for prior immunotherapy or persistence of active cellular therapy&#xD;
                  (e.g., chimeric antigen receptor T cell therapy; other cellular therapies must be&#xD;
                  discussed with the medical monitor to determine eligibility).&#xD;
&#xD;
               3. ≤ 28 days for a prior monoclonal antibody used for anticancer therapy except for&#xD;
                  denosumab.&#xD;
&#xD;
               4. ≤ 7 days for immune-suppressive-based treatment for any reason. Note: Use of&#xD;
                  inhaled or topical steroids or corticosteroid use for radiographic procedures is&#xD;
                  permitted. Note: The use of physiologic corticosteroid replacement therapy may be&#xD;
                  approved after consultation with the medical monitor.&#xD;
&#xD;
               5. ≤ 28 days or 5 half-lives (whichever is longer) before the first dose for all&#xD;
                  other investigational study drugs or devices. For investigational agents with&#xD;
                  long half-lives (e.g., &gt; 5 days), enrollment before the fifth half-life requires&#xD;
                  medical monitor approval.&#xD;
&#xD;
          -  Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior&#xD;
             immunotherapy) and/or complications from prior surgical intervention before starting&#xD;
             therapy. Note: Subjects with stable chronic conditions (≤ Grade 2) not expected to&#xD;
             resolve (such as neuropathy and alopecia) are exceptions and may enroll. Note:&#xD;
             Subjects with a history of any grade immune-related ocular AE (e.g., episcleritis,&#xD;
             scleritis, uveitis) will be excluded.&#xD;
&#xD;
          -  Receipt of a live vaccine within 30 days of planned start of study therapy. Note:&#xD;
             Examples of live vaccines include, but are not limited to, the following: measles,&#xD;
             mumps, rubella, chicken pox/zoster, yellow fever, rabies, Bacillus Calmette-Guérin,&#xD;
             and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed&#xD;
             virus vaccines and are allowed; however, intranasal influenza vaccines (e.g.,&#xD;
             FluMist®) are live attenuated vaccines and are not allowed.&#xD;
&#xD;
          -  Active autoimmune disease that required systemic treatment in the past (i.e., with use&#xD;
             of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Subjects&#xD;
             who have not required systemic treatment in the past 2 years may be eligible with&#xD;
             approval of the medical monitor. Note: Subjects with hyper/ hypothyroidism are&#xD;
             eligible to participate. Note: Replacement and symptomatic therapies (e.g.,&#xD;
             levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal&#xD;
             or pituitary insufficiency, etc.) are not considered a form of systemic immune&#xD;
             suppressive therapy and are allowed.&#xD;
&#xD;
          -  Known active CNS metastases and/or carcinomatous meningitis. Note: Subjects with&#xD;
             previously treated brain metastases may participate provided they are stable (without&#xD;
             evidence of progression by imaging for at least 28 days before the first dose of study&#xD;
             drug and any neurologic symptoms have returned to baseline), have no evidence of new&#xD;
             or enlarging brain metastases or CNS edema, and have not required steroids for at&#xD;
             least 7 days before the first dose of study drug.&#xD;
&#xD;
          -  Known additional malignancy that is progressing or requires active treatment, or&#xD;
             history of other malignancy within 2 years of study entry apart from cured basal cell&#xD;
             or squamous cell carcinoma of the skin, superficial bladder cancer, prostate&#xD;
             intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or&#xD;
             indolent malignancy, or cancers from which the subject has been disease-free for &gt; 1&#xD;
             year, after treatment with curative intent.&#xD;
&#xD;
          -  Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.&#xD;
&#xD;
          -  History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's&#xD;
             opinion, is clinically meaningful.&#xD;
&#xD;
          -  Active infection requiring systemic therapy.&#xD;
&#xD;
          -  Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of&#xD;
             reactivation. HBV-DNA and HCV-RNA must be undetectable. Subjects cannot be positive&#xD;
             for HBV-DNA, HCV-RNA, hepatitis B surface antigen, or anti-hepatitis B core antibody.&#xD;
             Note: Subjects with no prior history of hepatitis B infection who have been vaccinated&#xD;
             against hepatitis B and who have a positive antibody against hepatitis B surface&#xD;
             antigen test as the only evidence of prior exposure may participate in the study.&#xD;
&#xD;
          -  Known history of HIV (HIV 1 or HIV 2 antibodies).&#xD;
&#xD;
          -  Known allergy or reaction to any component of study drug or formulation components.&#xD;
&#xD;
          -  Is pregnant or breastfeeding or expecting to conceive or father children within the&#xD;
             projected duration of the study, starting with the screening visit through 60 days&#xD;
             after the last 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>Han Myint, MD</last_name>
    <role>Study Director</role>
    <affiliation>NextCure, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NIH National Cancer Institute (NCI)</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Theurer Cancer Center at Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Hillman Cancer Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>August 9, 2023</last_update_submitted>
  <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Advanced Cancer</keyword>
  <keyword>Metastatic Cancer</keyword>
  <keyword>NC410</keyword>
  <keyword>Solid Tumor</keyword>
  <keyword>Immunotherapy</keyword>
  <keyword>PK</keyword>
  <keyword>Ovarian Cancer</keyword>
  <keyword>Gastric Cancer</keyword>
  <keyword>Colo-rectal Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Rectal 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/NCT04408599
org study id: NC410-01
nct id: NCT04408599
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This research study is studying a new drug, NC410, as a possible treatment for advanced or
      metastatic solid tumors.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
time frame: up to 14 months
description: Frequency, duration, and severity of treatment-emergent adverse events (AEs)
measure: Define a maximum tolerated dose (MTD) or pharmacologically active dose (PAD)
time frame: 28 days
description: A 3 + 3 design will be utilized to determine the MTD of NC410
measure: Objective Response Rate per RECIST
time frame: 14 months
description: Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and modified RECIST (mRECIST) v1.1
measure: Duration of Response per RECIST
time frame: 14 months
description: Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and modified RECIST (mRECIST) v1.1
measure: Disease Control Rate per RECIST
time frame: 14 months
description: Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and modified RECIST (mRECIST) v1.1
measure: Maximum Plasma Concentration (Cmax) of NC410
time frame: 14 weeks
description: To evaluate the Maximum Plasma Concentration (Cmax) of NC410
arm group label: NC410
arm group type: Experimental
description: NC410 for IV infusion of various dose strengths administered in 14 day dosing cycles
intervention type: Drug
intervention name: NC410
description: NC410 is an experimental antibody drug that may make the immune response more active against cancer
arm group label: NC410
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Han Myint, MD
role: Study Director
affiliation: NextCure, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Stomach Neoplasms
mesh term: Rectal Neoplasms
sharing ipd: No