<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/NCT03782467</url>
  </required_header>
  <id_info>
    <org_study_id>A-18-1015-C-01</org_study_id>
    <nct_id>NCT03782467</nct_id>
  </id_info>
  <brief_title>Phase 1 Study in Patients With Advanced and/or Refractory Solid Malignancies to Evaluate the Safety of ATOR-1015</brief_title>
  <official_title>A First-in-human, Multicenter, Open-label, Phase 1 Study in Patients With Advanced and/or Refractory Solid Malignancies to Evaluate the Safety of Intravenously Administered ATOR-1015</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alligator Bioscience AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alligator Bioscience AB</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to investigate the safety and tolerability of ATOR-1015 when&#xD;
      administered as repeated intravenous infusions to patients with advanced and/or refractory&#xD;
      solid malignancies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Actual">March 3, 2021</completion_date>
  <primary_completion_date type="Actual">March 3, 2021</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>Safety and tolerability: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0</measure>
    <time_frame>From start of study until 28 days after last dose</time_frame>
    <description>Number of participants with treatment-related AEs assessed by CTCAE v5.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and tolerability: Vital signs</measure>
    <time_frame>From start of study until end of study (28-56 days after last dose)</time_frame>
    <description>Vital signs include blood pressure, pulse rate, oxygen saturation and body temperature. Clinically significant abnormal findings will be reported as AEs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and tolerability: Physical examination</measure>
    <time_frame>From start of study until end of study (28-56 days after last dose)</time_frame>
    <description>Physical examination will as a minimum include examination of mouth, throat, lymph nodes, respiratory, cardiovascular system, abdomen, extremities, neurological system and skin. Clinically significant abnormal findings will be reported as AEs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and tolerability: 12-lead electrocardiogram (ECG)</measure>
    <time_frame>From start of study until end of study (28-56 days after last dose)</time_frame>
    <description>Clinically significant abnormal ECG findings will be reported as AEs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and tolerability: Clinical laboratory tests</measure>
    <time_frame>From start of study until end of study (28-56 days after last dose)</time_frame>
    <description>Clinical laboratory tests include clinical chemistry, hematology, coagulation, hormones and urinalysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Maximum observed serum concentration of ATOR-1015 (Cmax)</measure>
    <time_frame>From start of study until end of study (28-56 days after last dose)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Time to Cmax</measure>
    <time_frame>From start of study until end of study (28-56 days after last dose)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Area under the ATOR-1015 serum concentration-time curve (AUC)</measure>
    <time_frame>From start of study until end of study (28-56 days after last dose)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity: Anti-drug antibody (ADA) titer in serum</measure>
    <time_frame>From start of study until end of study (28-56 days after last dose)</time_frame>
    <description>Levels of antibodies to ATOR-1015 will be evaluated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical efficacy: Anti-tumor activity assessed by response evaluation criteria in solid tumors for immune-based therapeutics (iRECIST)</measure>
    <time_frame>From start of study until end of study (28-56 days after last dose)</time_frame>
    <description>Computed tomography (CT) scans of tumors will be evaluated according to iRECIST</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Solid Tumor</condition>
  <condition>Neoplasms</condition>
  <arm_group>
    <arm_group_label>ATOR-1015</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ATOR-1015 administered by intravenous infusions every 2 weeks until confirmed progressive disease, unacceptable toxicity or withdrawal of consent.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ATOR-1015</intervention_name>
    <description>Bispecific human monoclonal antibody targeting cytotoxic T-lymphocyte associated protein 4 (CTLA-4) and OX40 (also known as CD134)</description>
    <arm_group_label>ATOR-1015</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Major Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of advanced and/or refractory solid malignancy&#xD;
&#xD;
          -  Eastern Cooperation Oncology Group (ECOG) performance status of 0 or 1&#xD;
&#xD;
          -  Life expectancy of at least 3 months&#xD;
&#xD;
        Major Exclusion Criteria:&#xD;
&#xD;
          -  Organ transplant recipient&#xD;
&#xD;
          -  Active autoimmune disorder&#xD;
&#xD;
          -  Other malignancy&#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>Malin Carlsson, MD</last_name>
    <role>Study Director</role>
    <affiliation>Alligator Bioscience AB</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeffrey Yachnin, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centrum för Kliniska Cancerstudier (CKC), Karolinska Universitetssjukhuset</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Phase 1 Unit, Department of Oncology, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>DK-2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Cancer Research, Department of Oncology, Herlev Hospital</name>
      <address>
        <city>Herlev</city>
        <zip>DK-2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kliniska Prövningsenheten, Kliniska Studier Sverige - Forum Söder, Skånes Universitetssjukhus</name>
      <address>
        <city>Lund</city>
        <zip>SE-221 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum för Kliniska Cancerstudier (CKC), Fas 1-enheten, Karolinska Universitetssjukhuset</name>
      <address>
        <city>Solna</city>
        <zip>SE-171 64</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onkologavdelningen, Akademiska Sjukhuset</name>
      <address>
        <city>Uppsala</city>
        <zip>SE-751 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Sweden</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>August 16, 2022</last_update_submitted>
  <last_update_submitted_qc>August 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</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/NCT03782467
org study id: A-18-1015-C-01
nct id: NCT03782467
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to investigate the safety and tolerability of ATOR-1015 when
      administered as repeated intravenous infusions to patients with advanced and/or refractory
      solid malignancies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and tolerability: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
time frame: From start of study until 28 days after last dose
description: Number of participants with treatment-related AEs assessed by CTCAE v5.0
measure: Safety and tolerability: Vital signs
time frame: From start of study until end of study (28-56 days after last dose)
description: Vital signs include blood pressure, pulse rate, oxygen saturation and body temperature. Clinically significant abnormal findings will be reported as AEs.
measure: Safety and tolerability: Physical examination
time frame: From start of study until end of study (28-56 days after last dose)
description: Physical examination will as a minimum include examination of mouth, throat, lymph nodes, respiratory, cardiovascular system, abdomen, extremities, neurological system and skin. Clinically significant abnormal findings will be reported as AEs.
measure: Safety and tolerability: 12-lead electrocardiogram (ECG)
time frame: From start of study until end of study (28-56 days after last dose)
description: Clinically significant abnormal ECG findings will be reported as AEs.
measure: Safety and tolerability: Clinical laboratory tests
time frame: From start of study until end of study (28-56 days after last dose)
description: Clinical laboratory tests include clinical chemistry, hematology, coagulation, hormones and urinalysis.
measure: Pharmacokinetics: Maximum observed serum concentration of ATOR-1015 (Cmax)
time frame: From start of study until end of study (28-56 days after last dose)
measure: Pharmacokinetics: Time to Cmax
time frame: From start of study until end of study (28-56 days after last dose)
measure: Pharmacokinetics: Area under the ATOR-1015 serum concentration-time curve (AUC)
time frame: From start of study until end of study (28-56 days after last dose)
measure: Immunogenicity: Anti-drug antibody (ADA) titer in serum
time frame: From start of study until end of study (28-56 days after last dose)
description: Levels of antibodies to ATOR-1015 will be evaluated
measure: Clinical efficacy: Anti-tumor activity assessed by response evaluation criteria in solid tumors for immune-based therapeutics (iRECIST)
time frame: From start of study until end of study (28-56 days after last dose)
description: Computed tomography (CT) scans of tumors will be evaluated according to iRECIST
arm group label: ATOR-1015
arm group type: Experimental
description: ATOR-1015 administered by intravenous infusions every 2 weeks until confirmed progressive disease, unacceptable toxicity or withdrawal of consent.
intervention type: Biological
intervention name: ATOR-1015
description: Bispecific human monoclonal antibody targeting cytotoxic T-lymphocyte associated protein 4 (CTLA-4) and OX40 (also known as CD134)
arm group label: ATOR-1015
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Malin Carlsson, MD
role: Study Director
affiliation: Alligator Bioscience AB
last name: Jeffrey Yachnin, Dr
role: Principal Investigator
affiliation: Centrum för Kliniska Cancerstudier (CKC), Karolinska Universitetssjukhuset
facility: 
facility: 
facility: 
facility: 
facility: 
country: Denmark
country: Sweden
responsible party type: Sponsor
mesh term: Neoplasms