<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/NCT04474470</url>
  </required_header>
  <id_info>
    <org_study_id>TYR-219-01</org_study_id>
    <nct_id>NCT04474470</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer</brief_title>
  <official_title>A Phase 1/2 Study With Open-Label, Dose Escalation Phase Followed by Single-Arm Expansion at the Maximum Tolerated Dose to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of NT219 Injection Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TyrNovo Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Purple Biotech Ltd.</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 phase 1/2, multi-center study with an open-label, dose escalation phase followed by&#xD;
      a single-arm expansion phase to assess the safety, tolerability, pharmacokinetics,&#xD;
      pharmacodynamics, and efficacy of NT219 alone and in combination with ERBITUX® (cetuximab) in&#xD;
      adults with recurrent and/or metastatic solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 3, 2020</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">June 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>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>Part 1: Incidence of treatment emergent adverse events</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Incidence of treatment emergent adverse events with single agent NT219</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Incidence of treatment emergent adverse events</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Incidence of treatment emergent adverse events with NT219 administered in combination with ERBITUX®</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 3: Objective Response Rate</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Objective Response Rate when phase 2 dose of NT219 is used in combination with ERBITUX® in adults with recurrent and/or metastatic SCCHN</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration curve [AUC]</measure>
    <time_frame>Up to 45 days after first study drug administration</time_frame>
    <description>Area under the plasma concentration curve [AUC] of NT219</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration [Cmax]</measure>
    <time_frame>Up to 45 days after first study drug administration</time_frame>
    <description>Maximum plasma concentration [Cmax] of NT219</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution at stead-state [Vss]</measure>
    <time_frame>Up to 45 days after first study drug administration</time_frame>
    <description>Volume of distribution at stead-state [Vss] of NT219</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma half-life [t1/2]</measure>
    <time_frame>Up to 45 days after first study drug administration</time_frame>
    <description>Plasma half-life [t1/2] of NT219</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma clearance [Cl]</measure>
    <time_frame>Up to 45 days after first study drug administration</time_frame>
    <description>Plasma clearance [Cl] of NT219</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate when NT219 is used as monotherapy</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response when NT219 is used as monotherapy</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Response when NT219 is used as monotherapy</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate when NT219 is used as monotherapy</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival when NT219 is used as monotherapy</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Progression when NT219 is used as monotherapy</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival when NT219 is used as monotherapy</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate when NT219 is used in combination with ERBITUX®</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response when NT219 is used in combination with ERBITUX®</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Response when NT219 is used in combination with ERBITUX®</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate when NT219 is used in combination with ERBITUX®</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival when NT219 is used in combination with ERBITUX®</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Progression when NT219 is used in combination with ERBITUX®</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival when NT219 is used in combination with ERBITUX®</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Solid Tumor, Adult</condition>
  <condition>Squamous Cell Carcinoma of Head and Neck</condition>
  <condition>Colorectal Adenocarcinoma</condition>
  <condition>Metastatic Solid Tumor</condition>
  <condition>Recurrent Solid Tumor</condition>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Dose escalation of NT219 as a single agent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose escalation of NT219 in combination with ERBITUX®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion cohort of NT219 in combination with ERBITUX®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NT219</intervention_name>
    <description>Dose escalation of NT219 as a single agent in adult subjects with recurrent and/or metastatic solid tumors</description>
    <arm_group_label>Dose escalation of NT219 as a single agent</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NT219 and ERBITUX® - Dose Escalation</intervention_name>
    <description>Dose escalation of NT219 in combination with standard dose ERBITUX® in adult subjects with recurrent and/or metastatic squamous cell carcinoma of the head and neck and colorectal adenocarcinoma</description>
    <arm_group_label>Dose escalation of NT219 in combination with ERBITUX®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NT219 and ERBITUX® - Expansion</intervention_name>
    <description>Expansion cohort of NT219 at its RP2D in combination with standard dose ERBITUX® in adult patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck</description>
    <arm_group_label>Expansion cohort of NT219 in combination with ERBITUX®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject with previously treated advanced solid tumors (Portion 1) or recurrent and/or&#xD;
             metastatic squamous cell carcinoma of the head and neck (Portion 2 and 3) or&#xD;
             colorectal adenocarcinoma, stage III/IV that must have failed or not be a candidate&#xD;
             for available standard of care therapies with documented progression/intolerance&#xD;
             following the most recent prior regimen;&#xD;
&#xD;
          2. Must have at least 1 measurable lesion per RECIST1.1 with progressing or new lesions&#xD;
             since last antitumor therapy;&#xD;
&#xD;
          3. ECOG performance status score of 0 or 1 at screening and baseline&#xD;
&#xD;
          4. Adequate safety lab results:&#xD;
&#xD;
               1. Albumin ≥3 g/dL;&#xD;
&#xD;
               2. Bilirubin ≤1.5 times the upper limit of normal (ULN) or &lt;3 times the ULN in the&#xD;
                  case of Gilbert Syndrome;&#xD;
&#xD;
               3. Aspartate aminotransaminase (AST), alanine aminotransaminase (ALT), and alkaline&#xD;
                  phosphatase &lt;3 times the ULN;&#xD;
&#xD;
               4. Creatinine clearance &gt;60 mL/minute based on the Cockcroft-Gault equation&#xD;
                  [creatinine clearance in mL/min = (140 - age in years) x body weight (kg)/72 x&#xD;
                  serum creatinine (mg/dL); multiplied by 0.85 for women];&#xD;
&#xD;
               5. White blood cell (WBC) count ≥2000/uL; hemoglobin ≥9 g/dL;&#xD;
&#xD;
          5. Stable brain metastases&#xD;
&#xD;
          6. Subjects must have a &quot;wash out&quot; period of at least 4 weeks prior to first study drug&#xD;
             administration from all previous chemotherapy and experimental agents except for&#xD;
             anti-CTLA4, anti-PD-L1, anti-PD-1 antibodies and IL-2 which must have a &quot;wash out&quot;&#xD;
             period of at least 6 weeks prior to first study drug administration, and all adverse&#xD;
             events (AEs) have either returned to baseline or stabilized at Grade 1 or less.&#xD;
&#xD;
          7. WCBP must have a negative serum pregnancy test at Screening and a negative urine&#xD;
             pregnancy test, WCBP must agree to abstain from sex or use an adequate method of&#xD;
             contraception, males must abstain from sex with WCBP or use an adequate method of&#xD;
             contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any invasive cancer (other than non-melanoma skin cancer) different from the current&#xD;
             disease within 3 years of Screening;&#xD;
&#xD;
          2. Known hypersensitivity to epidermal growth factor receptor (EGFR), Janus kinase (JAK),&#xD;
             or signal transducer and activator of transcription (STAT) antagonists/inhibitors, or&#xD;
             inactive ingredients of NT219.&#xD;
&#xD;
          3. Radiation or major surgery within 4 weeks prior to the first dose of NT219;&#xD;
&#xD;
          4. Treatment with another investigational therapy within 30 days or 5 halflives of the&#xD;
             drug prior to Screening, whichever is longer&#xD;
&#xD;
          5. Active, untreated central nervous system (CNS) metastases;&#xD;
&#xD;
          6. Severely immunocompromised as defined by white blood cell (WBC) count &lt;2000/mm3 and or&#xD;
             CD4+ lymphocyte count ≤200/mm3;&#xD;
&#xD;
          7. Major surgery within 4 weeks of study administration;&#xD;
&#xD;
          8. Any condition which, in the opinion of the PI, places the subject at unacceptable risk&#xD;
             if he/she were to participate in the study;&#xD;
&#xD;
          9. History of weight loss &gt;10% over the 2 months prior to Screening;&#xD;
&#xD;
         10. Clinically relevant serious co-morbid medical conditions, including:&#xD;
&#xD;
               -  Active infection; history of active or latent tuberculosis infection&#xD;
&#xD;
               -  Cardiovascular (e.g., History of long QT syndrome, NYHA) Class III or IV cardiac&#xD;
                  disease)&#xD;
&#xD;
               -  Pulmonary (e.g., GOLD score ≥3, chronic obstructive, chronic restrictive&#xD;
                  pulmonary disease)&#xD;
&#xD;
               -  Active CNS disease including carcinomatous meningitis;&#xD;
&#xD;
               -  Psychiatric illness/social situation that would limit compliance with study&#xD;
                  requirements;&#xD;
&#xD;
               -  Prior organ allograft;&#xD;
&#xD;
               -  Subjects with active, known or suspected autoimmune disease&#xD;
&#xD;
               -  History of active or latent tuberculosis infection&#xD;
&#xD;
               -  Uncontrolled infection HIV, HBV or HCV&#xD;
&#xD;
         11. Pregnant or lactating women;&#xD;
&#xD;
         12. Use of known UGT inhibitors within 14 days prior to first 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>Michael Schickler, PhD</last_name>
    <role>Study Director</role>
    <affiliation>TyrNovo Ltd.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael Schickler, PhD</last_name>
    <phone>+972 3 933 3121</phone>
    <email>trials@purple-biotech.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yifat Zaik, MSc</last_name>
    <phone>+972 54 5216 996</phone>
    <email>trials@purple-biotech.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>California Cancer Associates for Research and Excellence</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christina Spencer</last_name>
      <phone>760-452-3909</phone>
      <email>CSpencer@ccare.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Angeles Clinic and Research Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>UCSD Moores Cancer Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nidhi Patel</last_name>
      <phone>858-822-1962</phone>
      <email>nidpatel@health.ucsd.edu</email>
    </contact>
    <contact_backup>
      <last_name>Jona Plevin</last_name>
      <phone>+1-858-246-3253</phone>
      <email>jplevin@health.ucsd.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>MedStar Georgetown University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Montcalm</last_name>
      <phone>202-687-8974</phone>
      <email>jem257@georgetown.edu</email>
    </contact>
    <contact_backup>
      <last_name>Christina Benedict</last_name>
      <phone>+1-202-687-9861</phone>
      <email>cnb54@georgetown.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>The University of Chicago and Biological Sciences</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeffery Chin</last_name>
      <phone>773-834-5004</phone>
      <email>jchin18@medicine.bsd.uchicago.edu</email>
    </contact>
    <contact_backup>
      <last_name>Varsha Yarra</last_name>
      <phone>+1-773-702-7166</phone>
      <email>vyarra@bsd.uchicago.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Morgan Smith</last_name>
      <phone>504-703-7216</phone>
      <email>morgan.smith@ochsner.org</email>
    </contact>
    <contact_backup>
      <last_name>Amanda Woolery</last_name>
      <phone>+1-504-842-0275</phone>
      <email>Amanda.woolery@ochsner.org</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Stephenson Cancer Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73117</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christina Caldwell</last_name>
      <phone>405-271-8001</phone>
      <phone_ext>48171</phone_ext>
      <email>christina-caldwelL@ouhsc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hadassah University Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nechana Busheri</last_name>
      <phone>+972-54-5250296</phone>
      <email>nechamas@hadassah.org.il</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petah tikva</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chen Meir</last_name>
      <phone>+972-50-7189660</phone>
      <email>chenme3@clalit.org.il</email>
    </contact>
    <contact_backup>
      <last_name>Liad Carmel</last_name>
      <phone>+972-54-4594048</phone>
      <email>liadca@clalit.org.il</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aleksandra Kunin</last_name>
      <phone>+972-54-8066902</phone>
      <email>aleksandraku@tlvmc.gov.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NT219</keyword>
  <keyword>ERBITUX</keyword>
  <keyword>Cetuximab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Head and Neck Neoplasms</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>Cetuximab</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/NCT04474470
org study id: TYR-219-01
nct id: NCT04474470
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a phase 1/2, multi-center study with an open-label, dose escalation phase followed by
      a single-arm expansion phase to assess the safety, tolerability, pharmacokinetics,
      pharmacodynamics, and efficacy of NT219 alone and in combination with ERBITUX® (cetuximab) in
      adults with recurrent and/or metastatic solid tumors.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Part 1: Incidence of treatment emergent adverse events
time frame: Up to 24 months
description: Incidence of treatment emergent adverse events with single agent NT219
measure: Part 2: Incidence of treatment emergent adverse events
time frame: Up to 24 months
description: Incidence of treatment emergent adverse events with NT219 administered in combination with ERBITUX®
measure: Part 3: Objective Response Rate
time frame: Up to 24 months
description: Objective Response Rate when phase 2 dose of NT219 is used in combination with ERBITUX® in adults with recurrent and/or metastatic SCCHN
measure: Area under the plasma concentration curve [AUC]
time frame: Up to 45 days after first study drug administration
description: Area under the plasma concentration curve [AUC] of NT219
measure: Maximum plasma concentration [Cmax]
time frame: Up to 45 days after first study drug administration
description: Maximum plasma concentration [Cmax] of NT219
measure: Volume of distribution at stead-state [Vss]
time frame: Up to 45 days after first study drug administration
description: Volume of distribution at stead-state [Vss] of NT219
measure: Plasma half-life [t1/2]
time frame: Up to 45 days after first study drug administration
description: Plasma half-life [t1/2] of NT219
measure: Plasma clearance [Cl]
time frame: Up to 45 days after first study drug administration
description: Plasma clearance [Cl] of NT219
measure: Objective Response Rate when NT219 is used as monotherapy
time frame: Up to 24 months
measure: Duration of Response when NT219 is used as monotherapy
time frame: Up to 24 months
measure: Time to Response when NT219 is used as monotherapy
time frame: Up to 24 months
measure: Disease Control Rate when NT219 is used as monotherapy
time frame: Up to 24 months
measure: Progression Free Survival when NT219 is used as monotherapy
time frame: Up to 24 months
measure: Time to Progression when NT219 is used as monotherapy
time frame: Up to 24 months
measure: Overall Survival when NT219 is used as monotherapy
time frame: Up to 24 months
measure: Objective Response Rate when NT219 is used in combination with ERBITUX®
time frame: Up to 24 months
measure: Duration of Response when NT219 is used in combination with ERBITUX®
time frame: Up to 24 months
measure: Time to Response when NT219 is used in combination with ERBITUX®
time frame: Up to 24 months
measure: Disease Control Rate when NT219 is used in combination with ERBITUX®
time frame: Up to 24 months
measure: Progression Free Survival when NT219 is used in combination with ERBITUX®
time frame: Up to 24 months
measure: Time to Progression when NT219 is used in combination with ERBITUX®
time frame: Up to 24 months
measure: Overall Survival when NT219 is used in combination with ERBITUX®
time frame: Up to 24 months
arm group label: Dose escalation of NT219 as a single agent
arm group type: Experimental
arm group label: Dose escalation of NT219 in combination with ERBITUX®
arm group type: Experimental
arm group label: Expansion cohort of NT219 in combination with ERBITUX®
arm group type: Experimental
intervention type: Drug
intervention name: NT219
description: Dose escalation of NT219 as a single agent in adult subjects with recurrent and/or metastatic solid tumors
arm group label: Dose escalation of NT219 as a single agent
intervention type: Drug
intervention name: NT219 and ERBITUX® - Dose Escalation
description: Dose escalation of NT219 in combination with standard dose ERBITUX® in adult subjects with recurrent and/or metastatic squamous cell carcinoma of the head and neck and colorectal adenocarcinoma
arm group label: Dose escalation of NT219 in combination with ERBITUX®
intervention type: Drug
intervention name: NT219 and ERBITUX® - Expansion
description: Expansion cohort of NT219 at its RP2D in combination with standard dose ERBITUX® in adult patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck
arm group label: Expansion cohort of NT219 in combination with ERBITUX®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Schickler, PhD
role: Study Director
affiliation: TyrNovo Ltd.
last name: Michael Schickler, PhD
phone: +972 3 933 3121
email: trials@purple-biotech.com
last name: Yifat Zaik, MSc
phone: +972 54 5216 996
email: trials@purple-biotech.com
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
country: Israel
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Head and Neck Neoplasms
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Cetuximab
sharing ipd: No