<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/NCT04440735</url>
  </required_header>
  <id_info>
    <org_study_id>DSP107_001</org_study_id>
    <nct_id>NCT04440735</nct_id>
  </id_info>
  <brief_title>A Study of DSP107 Alone and in Combination With Atezolizumab for Patients With Advanced Solid Tumors</brief_title>
  <official_title>A First-in-Human, Two-Part, Open-Label, Phase I/II Study of DSP107 in Subjects With Advanced Solid Tumors Including a Dose-escalation Safety Study (Part 1) and Preliminary Efficacy Assessment of DSP107 as Monotherapy and in Combination With Atezolizumab (Part 2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kahr Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kahr Medical</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Part 1: A first-in-human, open-label, Phase I dose escalation study of DSP107 monotherapy and&#xD;
      combination therapy with atezolizumab in patients with advanced solid tumors.&#xD;
&#xD;
      Part 2: Preliminary efficacy assessment of DSP107 in combination with atezolizumab in second&#xD;
      or third line treatment of non small cell lung cancer. Preliminary efficacy assessment of&#xD;
      DSP107 as a single agent or in combination with atezolizumab in third line treatment of&#xD;
      colorectal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be the first time that DSP107 is administered to human subjects. The aim of&#xD;
      the study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and&#xD;
      preliminary efficacy of DSP107 monotherapy and combination therapy in a two-part design.&#xD;
&#xD;
      Part 1 will involve DSP107 monotherapy dose escalation in subjects with advanced solid tumors&#xD;
      that are not amenable to surgical resection or other approved therapeutic options that have&#xD;
      demonstrated clinical benefit. Additional dose finding cohorts will be enrolled to establish&#xD;
      a safe dose of DSP107 when given in combination with atezolizumab.&#xD;
&#xD;
      Part 2 will comprise two expansion cohorts:&#xD;
&#xD;
      A) Expansion cohort A consisting of one treatment arm in which subjects will be treated with&#xD;
      DSP107 in combination with atezolizumab. This expansion cohort will enroll subjects with non&#xD;
      small cell lung cancer who have progressed following no more than 2 lines of prior systemic&#xD;
      treatment including treatment with PD-1 or PD-L1 targeting agents.&#xD;
&#xD;
      B) Expansion cohort B consisting of two treatment arms in which subjects will be treated&#xD;
      either with DSP107 monotherapy or DSP107 in combination with atezolizumab. This expansion&#xD;
      cohort will enroll subjects with colorectal cancer who have progressed following two previous&#xD;
      lines of therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 7, 2020</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">September 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>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Part 1 will involve sequential enrollment of patient cohorts to investigate the safety of up to 7 potential dose levels. Dose escalation will commence with up to 3 single subject cohorts before moving to a 3 + 3 dose escalation scheme to determine the maximum tolerated dose and/or recommended phase II dose.&#xD;
Up to 3 additional dose finding cohorts will be enrolled in parallel to the monotherapy dose escalation to establish a safe dose of DSP107 when given in combination with atezolizumab. These dose-finding combination arms will start at least one dose level below a DSP107 monotherapy dose that has already been deemed safe.&#xD;
Part 2 will comprise 2 expansion cohorts:&#xD;
Expansion cohort A will involve enrollment of patients in a single arm receiving DSP107 in combination with atezolizumab.&#xD;
Expansion cohort B will involve enrollment of patients randomized to receive either DSP107 monotherapy or DSP107 in combination with atezolizumab.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events (AEs)</measure>
    <time_frame>Duration of the study, estimated to be 9 months</time_frame>
    <description>An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose Limiting Toxicities (DLT)</measure>
    <time_frame>At the end of Treatment Cycle 1 (each cycle is 21 days)</time_frame>
    <description>A DLT is defined as a clinically significant AE of laboratory abnormality that is related to DSP107 or the combination of DSP107 and atezolizumab, but is unrelated to disease progression, intercurrent illness or concomitant medications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DSP107 Serum Concentration</measure>
    <time_frame>At the end of Treatment Cycle 8 (each cycle is 21 days)</time_frame>
    <description>Serum samples will be collected to determine circulating levels and PK profile of DSP107</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DSP107 Effect on Phenotypic and Activation Profiles of Peripheral Blood Mononuclear Cells</measure>
    <time_frame>At the end of Treatment Cycle 8 (each cycle is 21 days)</time_frame>
    <description>Blood samples will be collected and examined by flow cytometry to determine the effect of DSP107 on different T-cells, B-cells, NK cells and monocytes, and their expression of activation markers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DSP107 and atezolizumab anti-drug antibody (ADA) formation</measure>
    <time_frame>Duration of the study, estimated to be 9 months</time_frame>
    <description>Serum samples will be collected throughout the study for assessment of ADA formation using validated assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preliminary Efficacy (Part 2 only)</measure>
    <time_frame>Duration of the study, estimated to be 12 months</time_frame>
    <description>Patients will undergo computed tomography (CT) scans to allow assessment of tumor response according to RECIST criteria</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">125</enrollment>
  <condition>Advanced Solid Tumor</condition>
  <condition>Non Small Cell Lung Cancer</condition>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>DSP107 monotherapy in advanced solid tumors</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DSP107 will be administered by intravenous infusion over 1 hour on Days 1, 8 and 15 of each 21-day cycle for up to 12 treatment cycles. Starting dose will be 0.01 mg/kg and maximum dose will not exceed 10 mg/kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DSP107 in combination with atezolizumab in advanced solid tumors</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DSP107 will be administered by IV infusion over 1 hour on Days 1, 8 and 15 of each 21-day cycle. Subjects will receive atezolizumab 1200 mg by intravenous infusion over 30 mins (first infusion over 1 hour) on Day 1 of every treatment cycle. DSP107 infusion will commence 1 hour following completion of atezolizumab infusion. The study will include up to 12 treatment cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DSP107 in combination with atezolizumab in non-small cell lung cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DSP107 10mg/kg will be administered by IV infusion over 1 hour on Days 1, 8 and 15 of each 21-day cycle. Subjects will receive atezolizumab 1200 mg by intravenous infusion over 30 mins (first infusion over 1 hour) on Day 1 of every treatment cycle. DSP107 infusion will commence 1 hour following completion of atezolizumab infusion. The study will include up to 12 treatment cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DSP107 monotherapy in colorectal cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DSP107 10mg/kg will be administered by intravenous infusion over 1 hour on Days 1, 8 and 15 of each 21-day cycle for up to 12 treatment cycles..</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DSP107 in combination with atezolizumab in colorectal cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DSP107 10mg/kg will be administered by IV infusion over 1 hour on Days 1, 8 and 15 of each 21-day cycle. Subjects will receive atezolizumab 1200 mg by intravenous infusion over 30 mins (first infusion over 1 hour) on Day 1 of every treatment cycle. DSP107 infusion will commence 1 hour following completion of atezolizumab infusion. The study will include up to 12 treatment cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>DSP107</intervention_name>
    <description>DSP107 (SIRPα - 4-1BBL) is a bi-functional, trimeric, fusion protein.</description>
    <arm_group_label>DSP107 in combination with atezolizumab in advanced solid tumors</arm_group_label>
    <arm_group_label>DSP107 in combination with atezolizumab in colorectal cancer</arm_group_label>
    <arm_group_label>DSP107 in combination with atezolizumab in non-small cell lung cancer</arm_group_label>
    <arm_group_label>DSP107 monotherapy in advanced solid tumors</arm_group_label>
    <arm_group_label>DSP107 monotherapy in colorectal cancer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <description>Atezolizumab is a humanized IgG1 monoclonal antibody that targets PD-L1</description>
    <arm_group_label>DSP107 in combination with atezolizumab in advanced solid tumors</arm_group_label>
    <arm_group_label>DSP107 in combination with atezolizumab in colorectal cancer</arm_group_label>
    <arm_group_label>DSP107 in combination with atezolizumab in non-small cell lung cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1&#xD;
&#xD;
          -  Subject must have measurable disease per RECIST version 1.1&#xD;
&#xD;
          -  Part 1:&#xD;
&#xD;
             o Histologically confirmed advanced solid tumor that is not amenable to surgical&#xD;
             resection or other approved therapeutic options that have demonstrated clinical&#xD;
             benefit or subject is intolerant or has refused available therapies&#xD;
&#xD;
          -  Part 2, Expansion Cohort A:&#xD;
&#xD;
               -  Histologically confirmed, inoperable non-small cell lung cancer (Stage 3b or&#xD;
                  Stage 4). Squamous and non-squamous histologies are both acceptable&#xD;
&#xD;
               -  Wildtype for actionable oncogenic driver mutations (e.g., ALK, EGFR, ROS1, RET,&#xD;
                  NTRK). Driver mutations for KRAS, BRAF and c-METex14skip will be allowed.&#xD;
&#xD;
               -  Received no more than 2 lines of prior systemic treatment, including anti PD-1 or&#xD;
                  anti PD-L1 therapeutic agent ± chemotherapy. Targeted therapies for KRAS, BRAF&#xD;
                  and c-METex14skip will not be counted towards the previous lines of therapy.&#xD;
&#xD;
          -  Part 2, Expansion Cohort B:&#xD;
&#xD;
               -  Histologically confirmed, inoperable microsatellite stable colorectal carcinoma&#xD;
                  (Stage 3b or Stage 4)&#xD;
&#xD;
               -  Received two previous lines of therapy including standard chemotherapy and/or&#xD;
                  targeted antibodies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life expectancy of ≤ 3 months&#xD;
&#xD;
          -  Central nervous system (CNS) metastases&#xD;
&#xD;
          -  Life-threatening (grade 4) immune-mediated adverse event related to prior&#xD;
             immunotherapy&#xD;
&#xD;
          -  Immune-mediated adverse reaction that required discontinuation of prior immunotherapy&#xD;
&#xD;
          -  Past or current history of autoimmune disease or immune deficiency&#xD;
&#xD;
          -  History of autoimmune hemolytic anemia or autoimmune thrombocytopenia&#xD;
&#xD;
          -  History of hematological malignancy&#xD;
&#xD;
          -  History of organ or stem cell transplantation&#xD;
&#xD;
          -  Clinically significant liver disease, including alcoholic hepatitis, cirrhosis, fatty&#xD;
             liver disease and inherited liver disease&#xD;
&#xD;
          -  Previously treatment with CAR-T cells&#xD;
&#xD;
          -  Treatment with systemic immunosuppressive medication within 2 weeks prior to first&#xD;
             dose of study treatment&#xD;
&#xD;
          -  Received live, attenuated vaccine within 4 weeks prior to first dose of study&#xD;
             treatment&#xD;
&#xD;
          -  Treatment with systemic immunostimulatory agents within 4 weeks prior to first dose of&#xD;
             study treatment&#xD;
&#xD;
          -  Treatment with atezolizumab, any CD47/SIRPα targeting agent or immune agonists (e.g.,&#xD;
             anti-CD137, anti-CD40, anti-OX40)&#xD;
&#xD;
          -  Known allergy or hypersensitivity to any of the test compounds, materials or&#xD;
             contraindication to test product&#xD;
&#xD;
          -  Clinically significant abnormal laboratory safety tests&#xD;
&#xD;
          -  Detection of anti DSP107 antibodies at screening&#xD;
&#xD;
          -  History of HIV infection or active Hepatitis B or C infection&#xD;
&#xD;
          -  Pregnant or breast feeding or planning to become pregnant while enrolled in the study&#xD;
&#xD;
          -  History or evidence of any other clinically unstable/uncontrolled disorder, condition,&#xD;
             or 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_official>
    <last_name>Jason Luke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anwaar Saeed, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jun Zhang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>KUMC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yaffa Shwartz</last_name>
    <phone>+972506396356</phone>
    <email>yaffa@kahr-medical.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Adam Foley-Comer, MD</last_name>
    <phone>+972547491753</phone>
    <email>adam@kahr-medical.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Moores Cancer Center, UCSD</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ashley Weaver</last_name>
      <phone>858-822-1962</phone>
      <email>aweaver@health.ucsd.edu</email>
    </contact>
    <investigator>
      <last_name>Sandip Patel, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital, Anschutz Cancer Pavilion (ACP)</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haley Stewart, BS, MS</last_name>
      <phone>720-848-0052</phone>
      <email>haley.stewart@cuanschutz.edu</email>
    </contact>
    <investigator>
      <last_name>Antonio Jimeno, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists</name>
      <address>
        <city>Lake Mary</city>
        <state>Florida</state>
        <zip>32746</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jessica Keville</last_name>
      <phone>407-804-6133</phone>
      <email>Jessica.Keville@flcancer.com</email>
    </contact>
    <investigator>
      <last_name>Alexander Philipovskiy, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Indiana University Simon Cancer Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jasmine Tracy</last_name>
      <phone>317-278-2528</phone>
      <email>jastracy@iu.edu</email>
    </contact>
    <investigator>
      <last_name>Rohan Maniar, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>KUCC / KUMCRI University of Kansas Cancer Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ankita Tiwari</last_name>
      <phone>913-588-2545</phone>
      <email>atiwari@kumc.edu</email>
    </contact>
    <investigator>
      <last_name>Jun Zhang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>SKCC-Sidney Kimmel Cancer Center 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>Tina M Savio</last_name>
      <phone>215-955-6407</phone>
      <email>Tina.Savio@jefferson.edu</email>
    </contact>
    <investigator>
      <last_name>Babar Bashir, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC Hillman Cancer Center University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Byers</last_name>
      <phone>412-623-8361</phone>
      <email>byersr@upmc.edu</email>
    </contact>
    <investigator>
      <last_name>Anwaar Saeed, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</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>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atezolizumab</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/NCT04440735
org study id: DSP107_001
nct id: NCT04440735
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
Part 1: A first-in-human, open-label, Phase I dose escalation study of DSP107 monotherapy and
      combination therapy with atezolizumab in patients with advanced solid tumors.

      Part 2: Preliminary efficacy assessment of DSP107 in combination with atezolizumab in second
      or third line treatment of non small cell lung cancer. Preliminary efficacy assessment of
      DSP107 as a single agent or in combination with atezolizumab in third line treatment of
      colorectal cancer.
This study will be the first time that DSP107 is administered to human subjects. The aim of
      the study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and
      preliminary efficacy of DSP107 monotherapy and combination therapy in a two-part design.

      Part 1 will involve DSP107 monotherapy dose escalation in subjects with advanced solid tumors
      that are not amenable to surgical resection or other approved therapeutic options that have
      demonstrated clinical benefit. Additional dose finding cohorts will be enrolled to establish
      a safe dose of DSP107 when given in combination with atezolizumab.

      Part 2 will comprise two expansion cohorts:

      A) Expansion cohort A consisting of one treatment arm in which subjects will be treated with
      DSP107 in combination with atezolizumab. This expansion cohort will enroll subjects with non
      small cell lung cancer who have progressed following no more than 2 lines of prior systemic
      treatment including treatment with PD-1 or PD-L1 targeting agents.

      B) Expansion cohort B consisting of two treatment arms in which subjects will be treated
      either with DSP107 monotherapy or DSP107 in combination with atezolizumab. This expansion
      cohort will enroll subjects with colorectal cancer who have progressed following two previous
      lines of therapy.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Part 1 will involve sequential enrollment of patient cohorts to investigate the safety of up to 7 potential dose levels. Dose escalation will commence with up to 3 single subject cohorts before moving to a 3 + 3 dose escalation scheme to determine the maximum tolerated dose and/or recommended phase II dose.
Up to 3 additional dose finding cohorts will be enrolled in parallel to the monotherapy dose escalation to establish a safe dose of DSP107 when given in combination with atezolizumab. These dose-finding combination arms will start at least one dose level below a DSP107 monotherapy dose that has already been deemed safe.
Part 2 will comprise 2 expansion cohorts:
Expansion cohort A will involve enrollment of patients in a single arm receiving DSP107 in combination with atezolizumab.
Expansion cohort B will involve enrollment of patients randomized to receive either DSP107 monotherapy or DSP107 in combination with atezolizumab.
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse Events (AEs)
time frame: Duration of the study, estimated to be 9 months
description: An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
measure: Dose Limiting Toxicities (DLT)
time frame: At the end of Treatment Cycle 1 (each cycle is 21 days)
description: A DLT is defined as a clinically significant AE of laboratory abnormality that is related to DSP107 or the combination of DSP107 and atezolizumab, but is unrelated to disease progression, intercurrent illness or concomitant medications
measure: DSP107 Serum Concentration
time frame: At the end of Treatment Cycle 8 (each cycle is 21 days)
description: Serum samples will be collected to determine circulating levels and PK profile of DSP107
measure: DSP107 Effect on Phenotypic and Activation Profiles of Peripheral Blood Mononuclear Cells
time frame: At the end of Treatment Cycle 8 (each cycle is 21 days)
description: Blood samples will be collected and examined by flow cytometry to determine the effect of DSP107 on different T-cells, B-cells, NK cells and monocytes, and their expression of activation markers.
measure: DSP107 and atezolizumab anti-drug antibody (ADA) formation
time frame: Duration of the study, estimated to be 9 months
description: Serum samples will be collected throughout the study for assessment of ADA formation using validated assay.
measure: Preliminary Efficacy (Part 2 only)
time frame: Duration of the study, estimated to be 12 months
description: Patients will undergo computed tomography (CT) scans to allow assessment of tumor response according to RECIST criteria
arm group label: DSP107 monotherapy in advanced solid tumors
arm group type: Experimental
description: DSP107 will be administered by intravenous infusion over 1 hour on Days 1, 8 and 15 of each 21-day cycle for up to 12 treatment cycles. Starting dose will be 0.01 mg/kg and maximum dose will not exceed 10 mg/kg.
arm group label: DSP107 in combination with atezolizumab in advanced solid tumors
arm group type: Experimental
description: DSP107 will be administered by IV infusion over 1 hour on Days 1, 8 and 15 of each 21-day cycle. Subjects will receive atezolizumab 1200 mg by intravenous infusion over 30 mins (first infusion over 1 hour) on Day 1 of every treatment cycle. DSP107 infusion will commence 1 hour following completion of atezolizumab infusion. The study will include up to 12 treatment cycles.
arm group label: DSP107 in combination with atezolizumab in non-small cell lung cancer
arm group type: Experimental
description: DSP107 10mg/kg will be administered by IV infusion over 1 hour on Days 1, 8 and 15 of each 21-day cycle. Subjects will receive atezolizumab 1200 mg by intravenous infusion over 30 mins (first infusion over 1 hour) on Day 1 of every treatment cycle. DSP107 infusion will commence 1 hour following completion of atezolizumab infusion. The study will include up to 12 treatment cycles.
arm group label: DSP107 monotherapy in colorectal cancer
arm group type: Experimental
description: DSP107 10mg/kg will be administered by intravenous infusion over 1 hour on Days 1, 8 and 15 of each 21-day cycle for up to 12 treatment cycles..
arm group label: DSP107 in combination with atezolizumab in colorectal cancer
arm group type: Experimental
description: DSP107 10mg/kg will be administered by IV infusion over 1 hour on Days 1, 8 and 15 of each 21-day cycle. Subjects will receive atezolizumab 1200 mg by intravenous infusion over 30 mins (first infusion over 1 hour) on Day 1 of every treatment cycle. DSP107 infusion will commence 1 hour following completion of atezolizumab infusion. The study will include up to 12 treatment cycles.
intervention type: Biological
intervention name: DSP107
description: DSP107 (SIRPα - 4-1BBL) is a bi-functional, trimeric, fusion protein.
arm group label: DSP107 in combination with atezolizumab in advanced solid tumors
arm group label: DSP107 in combination with atezolizumab in colorectal cancer
arm group label: DSP107 in combination with atezolizumab in non-small cell lung cancer
arm group label: DSP107 monotherapy in advanced solid tumors
arm group label: DSP107 monotherapy in colorectal cancer
intervention type: Biological
intervention name: Atezolizumab
description: Atezolizumab is a humanized IgG1 monoclonal antibody that targets PD-L1
arm group label: DSP107 in combination with atezolizumab in advanced solid tumors
arm group label: DSP107 in combination with atezolizumab in colorectal cancer
arm group label: DSP107 in combination with atezolizumab in non-small cell lung cancer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jason Luke, MD
role: Principal Investigator
affiliation: University of Pittsburgh
last name: Anwaar Saeed, MD
role: Principal Investigator
affiliation: University of Pittsburgh
last name: Jun Zhang, MD
role: Principal Investigator
affiliation: KUMC
last name: Yaffa Shwartz
phone: +972506396356
email: yaffa@kahr-medical.com
last name: Adam Foley-Comer, MD
phone: +972547491753
email: adam@kahr-medical.com
facility: 
status: Recruiting
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country: United States
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Colorectal Neoplasms
mesh term: Atezolizumab
sharing ipd: No