<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/NCT04452214</url>
  </required_header>
  <id_info>
    <org_study_id>CAN04CLIN002</org_study_id>
    <nct_id>NCT04452214</nct_id>
  </id_info>
  <brief_title>A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors</brief_title>
  <official_title>An Open-label, Safety and Tolerability Phase 1b Trial of CAN04, a Fully Humanized Anti-IL1RAP Monoclonal Antibody, and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cantargia AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cantargia AB</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 study will consider the safety and effectiveness of a study drug, CAN04, in combination&#xD;
      with pembrolizumab, in the treatment of incurable or metastatic non-small-cell lung cancer&#xD;
      (NSCLC), head and neck squamous cell carcinoma, urothelial cancer, or malignant melanoma. The&#xD;
      study aims to establish a recommended dose of CAN04 in combination with the standard dose of&#xD;
      pembrolizumab (Part 1), and in combination with pembrolizumab standard dose, and Standard of&#xD;
      Care carboplatin and pemetrexed (Part 2 - subjects with stage IV, non-squamous metastatic&#xD;
      NSCLC). CAN04, pembrolizumab. carboplatin and pemetrexed will be administered intravenously.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 24, 2020</start_date>
  <completion_date type="Actual">June 28, 2023</completion_date>
  <primary_completion_date type="Actual">June 28, 2023</primary_completion_date>
  <phase>Phase 1</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>Frequency of TEAEs (treatment-emergent adverse events) (Part 1)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of TEAEs (treatment-emergent adverse events) (Part 2)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with DLTs (dose-limiting toxicities) (Part 1)</measure>
    <time_frame>Up to day 28</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with DLTs (dose-limiting toxicities) (Part 2)</measure>
    <time_frame>Up to day 28</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with grade ≥3 TEAEs (Part 1)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with grade ≥3 TEAEs (Part 2)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of subjects with grade ≥3 TEAEs (Part 1)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of subjects with grade ≥3 TEAEs (Part 2)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with 1 or more SAEs (serious adverse events) (Part 1)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with 1 or more SAEs (serious adverse events) (Part 2)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of subjects with 1 or more SAEs (Part 1)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of subjects with 1 or more SAEs (Part 2)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with 1 or more TEAEs leading to dose modifications (Part 1)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with 1 or more TEAEs leading to dose modifications (Part 2)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 1)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 2)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of subjects with 1 or more TEAEs leading to dose modifications (Part 1)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of subjects with 1 or more TEAEs leading to dose modifications (Part 2)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 1)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 2)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum concentrations of CAN04 and pembrolizumab (Part 1)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum concentrations of CAN04 and pembrolizumab (Part 2)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antidrug antibodies (ADAs) against CAN04</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum IL-6 (interleukin-6) concentration (Part 1)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum IL-6 (interleukin-6) concentration (Part 2)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum CRP (C-reactive protein) concentration (Part 1)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum CRP (C-reactive protein) concentration (Part 2)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR) (Part 1)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
    <description>Proportion of subjects with partial response (PR) or complete response (CR) to study treatment as defined by iRECIST (immune-related response evaluation criteria in solid tumors) and measured by radiological assessment (CT/MRI scan)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR) (Part 2)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
    <description>Proportion of subjects with partial response (PR) or complete response (CR) to study treatment as defined by iRECIST (immune-related response evaluation criteria in solid tumors) and measured by radiological assessment (CT/MRI scan)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (Part 1)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (Part 2)</measure>
    <time_frame>From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (Part 1)</measure>
    <time_frame>Up to 36 months after 1st dose of last subject (or death)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (Part 2)</measure>
    <time_frame>Up to 36 months after 1st dose of last subject (or death)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Carcinoma, Non-Small-Cell Lung</condition>
  <condition>Urothelial Carcinoma</condition>
  <condition>Malignant Melanoma</condition>
  <condition>Head and Neck Squamous Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>CAN04 and pembrolizumab (Part 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive weekly doses of CAN04 in combination with pembrolizumab given as standard regimen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive doses of CAN04 on Days 1 and 8 (Cycles 1 thru 4), and on Day 1 (Cycle 5 onwards) in combination with pembrolizumab given as standard regimen and carboplatin and pemetrexed standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CAN04</intervention_name>
    <description>Administered intravenously</description>
    <arm_group_label>CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2)</arm_group_label>
    <arm_group_label>CAN04 and pembrolizumab (Part 1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Administered intravenously</description>
    <arm_group_label>CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2)</arm_group_label>
    <arm_group_label>CAN04 and pembrolizumab (Part 1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Administered intravenously</description>
    <arm_group_label>CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemetrexed</intervention_name>
    <description>Administered intravenously</description>
    <arm_group_label>CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (Part 1):&#xD;
&#xD;
          -  Subjects with metastatic or locally advanced, incurable non-small-cell lung cancer&#xD;
             (NSCLC [adenocarcinoma, adenosquamous, or squamous]), head and neck squamous cell&#xD;
             carcinoma (HNSCC), urothelial cancer, or malignant melanoma who have exhausted or&#xD;
             declined available standard therapy.&#xD;
&#xD;
          -  Subjects progressing on previous treatment with a checkpoint inhibitor targeting&#xD;
             thePD-1/PD-L1 pathway, alone or in combination with chemotherapy after previously&#xD;
             having achieved stable disease or better and stayed on such therapy for ≥12 weeks.&#xD;
&#xD;
          -  Primary or metastatic lesion suitable for biopsy and willingness to undergo repeat&#xD;
             biopsies as appropriate.&#xD;
&#xD;
          -  Willing and able to provide intravenous access for the administration of the study&#xD;
             drug and for blood sampling/testing.&#xD;
&#xD;
        Inclusion Criteria (Part 2):&#xD;
&#xD;
          -  Subjects with histologically confirmed non-squamous metastatic (stage IV) NSCLC,&#xD;
             without option for locoregional treatment with curative intent.&#xD;
&#xD;
          -  Subjects who have not received prior systemic anti-cancer therapy for the locally&#xD;
             advanced or metastatic NSCLC. Subjects who received adjuvant or neoadjuvant therapy&#xD;
             are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months&#xD;
             prior to the development of metastatic disease.&#xD;
&#xD;
          -  Ability to safety undergo pre-treatment (if no archival biopsy is available) and&#xD;
             on-treatment tumor biopsies.&#xD;
&#xD;
          -  Subject consents to retrieval of archival tumor tissue for screening in case no fresh&#xD;
             biopsy is performed during screening.&#xD;
&#xD;
          -  Willing and able to provide intravenous access for the administration of the study&#xD;
             drug and for blood sampling/testing.&#xD;
&#xD;
        Exclusion Criteria (Parts 1 and 2):&#xD;
&#xD;
          -  Subjects with NSCLC tumors with genetic alteration or mutation, for which FDA-approved&#xD;
             targeted therapy is available.&#xD;
&#xD;
          -  Treatment with systemic anticancer treatments, investigational products, or major&#xD;
             surgery within 4 weeks before first dose of study drug or 5 half-lives, whichever is&#xD;
             shorter. Subjects should have recovered from previous treatment toxicity (except hair&#xD;
             loss and peripheral neuropathy).&#xD;
&#xD;
          -  History of uncontrolled brain metastasis.&#xD;
&#xD;
          -  Subject has received extended field radiotherapy ≤4 weeks before the start of&#xD;
             treatment (≤2 weeks for limited field radiation to alleviate symptoms), and who has&#xD;
             not recovered from related side effects of such therapy (except for hair loss).&#xD;
&#xD;
          -  Subjects who have previously experienced an immune-related adverse event (irAE) to&#xD;
             pembrolizumab, for which permanent discontinuation is required. Subjects without a&#xD;
             formal contraindication due to previous irAE are not eligible if the AE has not&#xD;
             resolved or requires steroids (&gt;10 mg prednisone-equivalent per day) for ongoing&#xD;
             management.&#xD;
&#xD;
          -  Subjects with active severe infection requiring oral antibiotics.&#xD;
&#xD;
          -  Clinical evidence of an active second invasive malignancy with the exception of stable&#xD;
             prostate cancer on watchful waiting.&#xD;
&#xD;
          -  Uncontrolled or significant cardiovascular disease.&#xD;
&#xD;
          -  History of autoimmune disease requiring systemic immunosuppressive therapy (daily&#xD;
             prednisone equivalent doses &gt;10 mg/day).&#xD;
&#xD;
          -  HIV patients can be enrolled if the infection is adequately controlled.&#xD;
&#xD;
          -  Known bleeding disorder or coagulopathy. Subjects on stable anticoagulant therapy are&#xD;
             allowed.&#xD;
&#xD;
          -  Known or suspected allergy to study treatment or related products.&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding, or trying to become pregnant.&#xD;
&#xD;
          -  Patients with chronic viral hepatitis.&#xD;
&#xD;
        Exclusion criteria (Part 2):&#xD;
&#xD;
          -  Previous therapy with immunotherapy (anti-PD-1, anti-PD-L1, and anti-PD-L2,&#xD;
             anti-CTLA-4, or other approved or investigational checkpoint-inhibitors).&#xD;
&#xD;
          -  Subject is unable or unwilling to take folic acid or vitamin B12 supplementation.&#xD;
&#xD;
          -  Subject is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs&#xD;
             (NSAIDS), other than an aspirin dose ≤ 1.3 g per day, for a 5-day period (8-day period&#xD;
             for long-acting agents, such as piroxicam).&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria may apply.&#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>Ignacio Garcia-Ribas, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Cantargia AB</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Cancer Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists &amp; Research Institute</name>
      <address>
        <city>Lake Mary</city>
        <state>Florida</state>
        <zip>32746</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of The University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104-5127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <link>
    <url>http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts</url>
    <description>FDA Recalls, Market Withdrawals, and Safety Alerts</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>July 13, 2023</last_update_submitted>
  <last_update_submitted_qc>July 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NSCLC</keyword>
  <keyword>Adenocarcinoma of lung</keyword>
  <keyword>Lung cancer</keyword>
  <keyword>Squamous cell lung cancer</keyword>
  <keyword>Malignant melanoma</keyword>
  <keyword>Urothelial cancer</keyword>
  <keyword>Non-small-cell lung cancer</keyword>
  <keyword>Non small cell lung cancer</keyword>
  <keyword>Non-small-cell lung carcinoma</keyword>
  <keyword>Non small cell lung carcinoma</keyword>
  <keyword>HNSCC</keyword>
  <keyword>Head and neck squamous cell 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>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Pembrolizumab</mesh_term>
    <mesh_term>Pemetrexed</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/NCT04452214
org study id: CAN04CLIN002
nct id: NCT04452214
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study will consider the safety and effectiveness of a study drug, CAN04, in combination
      with pembrolizumab, in the treatment of incurable or metastatic non-small-cell lung cancer
      (NSCLC), head and neck squamous cell carcinoma, urothelial cancer, or malignant melanoma. The
      study aims to establish a recommended dose of CAN04 in combination with the standard dose of
      pembrolizumab (Part 1), and in combination with pembrolizumab standard dose, and Standard of
      Care carboplatin and pemetrexed (Part 2 - subjects with stage IV, non-squamous metastatic
      NSCLC). CAN04, pembrolizumab. carboplatin and pemetrexed will be administered intravenously.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Frequency of TEAEs (treatment-emergent adverse events) (Part 1)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Frequency of TEAEs (treatment-emergent adverse events) (Part 2)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Number of participants with DLTs (dose-limiting toxicities) (Part 1)
time frame: Up to day 28
measure: Number of participants with DLTs (dose-limiting toxicities) (Part 2)
time frame: Up to day 28
measure: Number of subjects with grade ≥3 TEAEs (Part 1)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Number of subjects with grade ≥3 TEAEs (Part 2)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Percentage of subjects with grade ≥3 TEAEs (Part 1)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Percentage of subjects with grade ≥3 TEAEs (Part 2)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Number of subjects with 1 or more SAEs (serious adverse events) (Part 1)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Number of subjects with 1 or more SAEs (serious adverse events) (Part 2)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Percentage of subjects with 1 or more SAEs (Part 1)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Percentage of subjects with 1 or more SAEs (Part 2)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Number of subjects with 1 or more TEAEs leading to dose modifications (Part 1)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Number of subjects with 1 or more TEAEs leading to dose modifications (Part 2)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Number of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 1)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Number of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 2)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Percentage of subjects with 1 or more TEAEs leading to dose modifications (Part 1)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Percentage of subjects with 1 or more TEAEs leading to dose modifications (Part 2)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 1)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 2)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Serum concentrations of CAN04 and pembrolizumab (Part 1)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Serum concentrations of CAN04 and pembrolizumab (Part 2)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Antidrug antibodies (ADAs) against CAN04
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Change in serum IL-6 (interleukin-6) concentration (Part 1)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Change in serum IL-6 (interleukin-6) concentration (Part 2)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Change in serum CRP (C-reactive protein) concentration (Part 1)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Change in serum CRP (C-reactive protein) concentration (Part 2)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Overall response rate (ORR) (Part 1)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
description: Proportion of subjects with partial response (PR) or complete response (CR) to study treatment as defined by iRECIST (immune-related response evaluation criteria in solid tumors) and measured by radiological assessment (CT/MRI scan)
measure: Overall response rate (ORR) (Part 2)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
description: Proportion of subjects with partial response (PR) or complete response (CR) to study treatment as defined by iRECIST (immune-related response evaluation criteria in solid tumors) and measured by radiological assessment (CT/MRI scan)
measure: Progression free survival (Part 1)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Progression free survival (Part 2)
time frame: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
measure: Overall survival (Part 1)
time frame: Up to 36 months after 1st dose of last subject (or death)
measure: Overall survival (Part 2)
time frame: Up to 36 months after 1st dose of last subject (or death)
arm group label: CAN04 and pembrolizumab (Part 1)
arm group type: Experimental
description: Subjects will receive weekly doses of CAN04 in combination with pembrolizumab given as standard regimen
arm group label: CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2)
arm group type: Experimental
description: Subjects will receive doses of CAN04 on Days 1 and 8 (Cycles 1 thru 4), and on Day 1 (Cycle 5 onwards) in combination with pembrolizumab given as standard regimen and carboplatin and pemetrexed standard of care
intervention type: Drug
intervention name: CAN04
description: Administered intravenously
arm group label: CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2)
arm group label: CAN04 and pembrolizumab (Part 1)
intervention type: Drug
intervention name: Pembrolizumab
description: Administered intravenously
arm group label: CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2)
arm group label: CAN04 and pembrolizumab (Part 1)
intervention type: Drug
intervention name: Carboplatin
description: Administered intravenously
arm group label: CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2)
intervention type: Drug
intervention name: Pemetrexed
description: Administered intravenously
arm group label: CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ignacio Garcia-Ribas, MD, PhD
role: Study Director
affiliation: Cantargia AB
facility: 
facility: 
facility: 
country: United States
url: http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
url: http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
description: FDA Recalls, Market Withdrawals, and Safety Alerts
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Melanoma
mesh term: Carcinoma, Squamous Cell
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Carboplatin
mesh term: Pembrolizumab
mesh term: Pemetrexed
sharing ipd: No