<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/NCT04442126</url>
  </required_header>
  <id_info>
    <org_study_id>NB-ND021 (NM21-1480)-101</org_study_id>
    <secondary_id>2020-0355</secondary_id>
    <nct_id>NCT04442126</nct_id>
  </id_info>
  <brief_title>A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors</brief_title>
  <official_title>A Phase 1/2 Study of NM21-1480 (Anti-PDL-1/Anti-4-1BB/Anti-HSA Tri-Specific Antibody) in Adult Patients With Advanced Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Numab Therapeutics AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Numab Therapeutics AG</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a first-in-human, open-label, multi-center, Phase 1/2, dose-escalation study with&#xD;
      expansion cohorts to evaluate NM21-1480 for safety and immunogenicity, to determine the&#xD;
      maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, to explore&#xD;
      the pharmacodynamics, and to obtain preliminary evidence of the clinical activity in adult&#xD;
      patients with selected advanced solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 19, 2020</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2024</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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v5.0</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Frequency and severity of adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Tolerated Dose (MTD) of NM21-1480</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>To determine the MTD of NM21-1480</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determination of Phase 2 dose of NM21-1480</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>To determine the recommended Phase 2 dose of NM21-1480 for Part B of the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To determine the anti-tumor activity (Best Overall Response) of NM21-1480 according to RECIST 1.1</measure>
    <time_frame>Up to 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>To determine the anti-tumor activity (Overall Response Rate) of NM21-1480 according to RECIST 1.1</measure>
    <time_frame>Up to 3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of the maximum observed serum concentration determined by direct inspection of the concentration versus time data (Cmax)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the the minimum observed serum concentration determined by direct inspection of the concentration versus time data (Cmin)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the time from dosing at which Cmax is apparent determined by direct inspection of the concentration versus time data (Tmax)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the terminal phase (apparent elimination) rate constant (λz)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the elimination half-life (t½)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the area under the serum concentration-time curve extrapolated from the last quantifiable concentration to infinity (AUC[0-infinity])</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the area under serum concentration-time curve over dosing interval (AUCtau)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the clearance (CL)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the volume of distribution (Vd)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the frequency of specific anti-drug antibodies to NM21-1480</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the anti-tumor activity (Disease Control Rate) of NM21-1480 according to RECIST 1.1</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the anti-tumor activity (Duration of Response) of NM21-1480 according to RECIST 1.1</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the anti-tumor activity (Time-to-response) of NM21-1480 according to RECIST 1.1</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the anti-tumor activity (Progression-free survival) of NM21-1480 according to RECIST 1.1</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the anti-tumor activity (Overall Survival) of NM21-1480 according to RECIST 1.1</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">406</enrollment>
  <condition>Advanced Solid Tumor</condition>
  <condition>Non-small Cell Lung Cancer</condition>
  <condition>Colorectal Cancer</condition>
  <condition>Squamous Cell Carcinoma</condition>
  <condition>Ovarian Carcinoma</condition>
  <condition>Peritoneal Carcinoma</condition>
  <condition>Fallopian Tube Cancer</condition>
  <condition>Head and Neck Squamous Cell Carcinoma</condition>
  <condition>Triple Negative Breast Cancer</condition>
  <arm_group>
    <arm_group_label>NM21-1480 Treatment arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NM21-1480</intervention_name>
    <description>Trispecific anti-PD-L1/anti-4-1BB/anti-Human Serum Albumin (HSA) single-chain Fv fusion protein</description>
    <arm_group_label>NM21-1480 Treatment arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Part A&#xD;
&#xD;
          -  Patients with any previously treated solid tumor-type other than hepatocellular&#xD;
             carcinoma or intrahepatic cholangiocarcinoma that is advanced, or recurrent and&#xD;
             progressing since last anti-tumor therapy, and for which no alternative, standard&#xD;
             therapy exists.&#xD;
&#xD;
          -  Prior chemotherapy, radiation therapy or immunotherapy must have been completed at&#xD;
             least 4 weeks prior to the administration of the first dose of study drug, and patient&#xD;
             has recovered&#xD;
&#xD;
        Part B:&#xD;
&#xD;
          -  Patients with Non-small Cell Lung Cancer (NSCLC) or other protocol specified solid&#xD;
             tumors with locally advanced or metastatic, non-resectable disease, which has&#xD;
             progressed despite treatment with first-line standard of-care treatment, or first- and&#xD;
             second-line treatment, dependent on expansion cohort.&#xD;
&#xD;
          -  Prior therapy must have been completed 2-4 weeks prior to the administration of the&#xD;
             first dose of study drug as specified per protocol according to type of prior therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient previously had known immediate or delayed hypersensitivity reaction or&#xD;
             idiosyncrasy to the excipients&#xD;
&#xD;
          -  Part A: Treatment with any PD-1, or Cytotoxic T-Lymphocyte Associated Protein (CTLA)-4&#xD;
             directed antibody, or with any other immunotherapy within 4 weeks prior to initiation&#xD;
             of the study drug.&#xD;
&#xD;
          -  Part A: Use of other biological investigational drugs (drugs not marketed for any&#xD;
             indication), including use of investigational drugs targeting CD137/4-1BB within at&#xD;
             least 5 half-lives (or within 8 weeks, whatever is longer) prior to the administration&#xD;
             of the first dose of study drug.&#xD;
&#xD;
          -  Part B: As defined per protocol for each expansion cohort, has not been treated with&#xD;
             specified first/second-line standard-of-care therapies biological drugs (marketed or&#xD;
             investigational) for treatment of the current cancer, or has not adequately recovered&#xD;
             from AEs that occurred with prior therapy.&#xD;
&#xD;
          -  Patient has an active autoimmune disease or a documented history of autoimmune&#xD;
             disease.&#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_contact>
    <last_name>Peter Lichtlen, MD, PhD, BBA</last_name>
    <phone>+41-44-533-22-92</phone>
    <email>clinicaltrials@numab.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Augusta University Medical Center</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sharad Ghamande</last_name>
      <phone>706-721-2535</phone>
      <email>sghamande@augusta.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tulane University Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mark Sides</last_name>
      <phone>504-988-6121</phone>
      <email>msides@tulane.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shirish Gadgeel</last_name>
      <phone>734-647-6883</phone>
      <email>sgadgee1@hfhs.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>St. Joseph Mercy Hospital</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48197</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tareq Al Baghdadi</last_name>
      <phone>734-712-1000</phone>
      <email>tareq_albaghdadi@ihacares.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461-2374</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Balazs Halmos</last_name>
      <phone>718-405-8404</phone>
      <email>bahalmos@montefiore.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elaine Shum</last_name>
      <phone>212-731-6363</phone>
      <email>Elaine.Shum@nyulangone.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Johnson</last_name>
      <phone>215-955-8875</phone>
      <email>jennifer.m.johnson@jefferson.edu</email>
    </contact>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Jason Luke</last_name>
      <phone>412-623-4511</phone>
      <email>lukejj@upmc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina (MUSC)</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brian Orr</last_name>
      <phone>843-792-1634</phone>
      <email>orrb@musc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Cancer Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melissa L. Johnson, MD</last_name>
      <phone>615-524-4195</phone>
      <email>mjohnson@tnonc.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The University Of Texas 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>David S Hong, MD</last_name>
      <phone>713-563-7930</phone>
      <email>dshong@mdanderson.org</email>
    </contact>
  </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>Alexander Spira</last_name>
      <phone>703-280-5390</phone>
      <email>alexander.spira@usoncology.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de A Coruna</name>
      <address>
        <city>A Coruña</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joaquin Mosquera Martine</last_name>
      <phone>34981178000</phone>
      <email>joaquin.mosquera.martinez@sergas.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Elche</name>
      <address>
        <city>Elche</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Guirado Risueno</last_name>
      <phone>966616250</phone>
      <email>mguiradorisu@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Jaen</name>
      <address>
        <city>Jaén</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ana-Laura Ortega Granados</last_name>
      <phone>953220306</phone>
      <email>analauraortega@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro Integral Oncologico Clara Campal</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Jose de Miguel Luken</last_name>
      <phone>917567825</phone>
      <email>maria.demiguel@startmadrid.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinica Universidad de Navarra - Madrid</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ignacio Melero</last_name>
      <email>imelero@unav.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de la Victoria</name>
      <address>
        <city>Málaga</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laura Medina Rodriguez</last_name>
      <phone>0034 951 032 250</phone>
      <email>laura.medina@ibima.eu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Son Llatzer</name>
      <address>
        <city>Palma De Mallorca</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juan Coves Sarto</last_name>
      <email>jcoves@hsll.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinica Universidad de Navarra - Pamplona</name>
      <address>
        <city>Pamplona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ignacio Melero</last_name>
      <email>imelero@unav.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen Macarena</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Vicente Baz</last_name>
      <phone>954712941</phone>
      <email>dvicentebaz@yahoo.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politecnic La Fe</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Oscar Juan Vidal</last_name>
      <phone>961245872</phone>
      <email>juan_osc@gva.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James Chih-Hsin Yang, MD, PhD</last_name>
      <phone>02-23123456</phone>
      <phone_ext>67511</phone_ext>
      <email>chihyang@ntu.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>January 13, 2023</last_update_submitted>
  <last_update_submitted_qc>January 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Carcinoma</keyword>
  <keyword>Neoplasms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Triple Negative Breast Neoplasms</mesh_term>
    <mesh_term>Fallopian Tube Neoplasms</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
  </condition_browse>
  <!-- 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/NCT04442126
org study id: NB-ND021 (NM21-1480)-101
secondary id: 2020-0355
nct id: NCT04442126
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a first-in-human, open-label, multi-center, Phase 1/2, dose-escalation study with
      expansion cohorts to evaluate NM21-1480 for safety and immunogenicity, to determine the
      maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, to explore
      the pharmacodynamics, and to obtain preliminary evidence of the clinical activity in adult
      patients with selected advanced solid tumors.
allocation: N/A
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
time frame: Up to 3 years
description: Frequency and severity of adverse events
measure: Maximum Tolerated Dose (MTD) of NM21-1480
time frame: Up to 3 years
description: To determine the MTD of NM21-1480
measure: Determination of Phase 2 dose of NM21-1480
time frame: Up to 3 years
description: To determine the recommended Phase 2 dose of NM21-1480 for Part B of the study
measure: To determine the anti-tumor activity (Best Overall Response) of NM21-1480 according to RECIST 1.1
time frame: Up to 3 years
measure: To determine the anti-tumor activity (Overall Response Rate) of NM21-1480 according to RECIST 1.1
time frame: Up to 3 years
measure: Assessment of the maximum observed serum concentration determined by direct inspection of the concentration versus time data (Cmax)
time frame: Up to 3 years
measure: Assessment of the the minimum observed serum concentration determined by direct inspection of the concentration versus time data (Cmin)
time frame: Up to 3 years
measure: Assessment of the time from dosing at which Cmax is apparent determined by direct inspection of the concentration versus time data (Tmax)
time frame: Up to 3 years
measure: Assessment of the terminal phase (apparent elimination) rate constant (λz)
time frame: Up to 3 years
measure: Assessment of the elimination half-life (t½)
time frame: Up to 3 years
measure: Assessment of the area under the serum concentration-time curve extrapolated from the last quantifiable concentration to infinity (AUC[0-infinity])
time frame: Up to 3 years
measure: Assessment of the area under serum concentration-time curve over dosing interval (AUCtau)
time frame: Up to 3 years
measure: Assessment of the clearance (CL)
time frame: Up to 3 years
measure: Assessment of the volume of distribution (Vd)
time frame: Up to 3 years
measure: Assessment of the frequency of specific anti-drug antibodies to NM21-1480
time frame: Up to 3 years
measure: To determine the anti-tumor activity (Disease Control Rate) of NM21-1480 according to RECIST 1.1
time frame: Up to 3 years
measure: To determine the anti-tumor activity (Duration of Response) of NM21-1480 according to RECIST 1.1
time frame: Up to 3 years
measure: To determine the anti-tumor activity (Time-to-response) of NM21-1480 according to RECIST 1.1
time frame: Up to 3 years
measure: To determine the anti-tumor activity (Progression-free survival) of NM21-1480 according to RECIST 1.1
time frame: Up to 3 years
measure: To determine the anti-tumor activity (Overall Survival) of NM21-1480 according to RECIST 1.1
time frame: Up to 3 years
arm group label: NM21-1480 Treatment arm
arm group type: Experimental
intervention type: Biological
intervention name: NM21-1480
description: Trispecific anti-PD-L1/anti-4-1BB/anti-Human Serum Albumin (HSA) single-chain Fv fusion protein
arm group label: NM21-1480 Treatment arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Lichtlen, MD, PhD, BBA
phone: +41-44-533-22-92
email: clinicaltrials@numab.com
facility: 
status: Recruiting
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contact: 
country: Spain
country: Taiwan
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Triple Negative Breast Neoplasms
mesh term: Fallopian Tube Neoplasms
mesh term: Squamous Cell Carcinoma of Head and Neck