<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/NCT04471727</url>
  </required_header>
  <id_info>
    <org_study_id>HPN328-4001</org_study_id>
    <nct_id>NCT04471727</nct_id>
  </id_info>
  <brief_title>Study in Patients With Advanced Cancers Associated With Expression of DLL3</brief_title>
  <official_title>A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN328 Monotherapy and HPN328 With Atezolizumab in Patients With Advanced Cancers Associated With Expression of Delta-like Canonical Notch Ligand 3 (DLL3)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harpoon Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Harpoon Therapeutics</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>
      A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety,&#xD;
      Tolerability, and Pharmacokinetics of HPN328 Monotherapy and HPN328 With Atezolizumab in&#xD;
      Patients With Advanced Cancers Associated With Expression of Delta-like Canonical Notch&#xD;
      Ligand 3 (DLL3)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 29, 2020</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency and severity of treatment-emergent AEs (TEAEs) graded according to NCI CTACAE version 5.0 (ASTCT grading criteria for CRS and ICANS).</measure>
    <time_frame>Up to 4 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number and severity of DLTs following treatment with HPN328 as monotherapy or in combination with atezolizumab.</measure>
    <time_frame>Up to 4 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK parameters of HPN328 as monotherapy or in combination with atezolizumab.</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Single dose - maximum concentration, time to maximum concentration, area under the single dose concentration-time curve over the dosing interval, area under the concentration-time curve extrapolated to infinity, terminal elimination half-life, and clearance as data permit&#xD;
Multiple dose (assuming stead state is achieved) - maximum concentration at steady state, time to maximum concentration, area under the steady state concentration-time curve over dosing interval, terminal elimination half-life, minimum concentration, clearance, volume of distribution, and accumulation ratio as data permit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in selected clinical laboratory parameters, vital signs, and ECGs.</measure>
    <time_frame>Up to 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (ORR) based on RECIST v1.1 (PCWG3 for patients with NEPC)</measure>
    <time_frame>Up to 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extra-cranial objective response rate (EC-ORR) based on modified RECIST v1.1</measure>
    <time_frame>Up to 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Overall Response (BOR)</measure>
    <time_frame>Up to 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>Up to 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extra-cranial progression free survival (EC-PFS)</measure>
    <time_frame>Up to 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Up to 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR)</measure>
    <time_frame>Up to 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of extra-cranial response (EC-DOR)</measure>
    <time_frame>Up to 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and titers of ADAs against HPN328 and atezolizumab (for combination-treatment patients)</measure>
    <time_frame>Up to 4 years</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">162</enrollment>
  <condition>Small-cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>HPN328 monotherapy dose escalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HPN328 will be administered as a single agent once weekly via IV infusion during each 21 day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HPN328 monotherapy dose escalation with extended dosing intervals</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HPN328 will be administered as a single agent, via IV infusion either once every 2 weeks (28-day cycle), or once every 3 weeks (21-day cycle).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HPN328 dose escalation in combination with atezolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SCLC patients will be treated with a combination regimen of HPN328 and atezolizumab. HPN328 will be administered once every 2 weeks via IV infusion during each 28-day cycle. Atezolizumab will be administered once every 4 weeks via IV infusion on Day 1 of each 28-day cycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HPN328</intervention_name>
    <description>HPN328 is a tri-specific recombinant protein construct (Tri-specific T Cell Activating Construct [TriTAC®]) containing 3 humanized antibody derived binding domains</description>
    <arm_group_label>HPN328 dose escalation in combination with atezolizumab</arm_group_label>
    <arm_group_label>HPN328 monotherapy dose escalation</arm_group_label>
    <arm_group_label>HPN328 monotherapy dose escalation with extended dosing intervals</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <description>Atezolizumab is a humanized immunoglobulin (Ig) G1 monoclonal antibody which potently and selectively inhibits binding of programmed death receptor 1 ligand (PD-L1) on tumor cells and tumor infiltrating immune cells in the tumor microenvironment</description>
    <arm_group_label>HPN328 dose escalation in combination with atezolizumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Major Inclusion Criteria:&#xD;
&#xD;
          1. Histologically or cytologically confirmed malignancy associated with expression of&#xD;
             DLL3:&#xD;
&#xD;
               -  SCLC which is relapsed/refractory following at least 1 prior line of systemic&#xD;
                  therapy that included platinum-based chemotherapy&#xD;
&#xD;
               -  Neuroendocrine Prostate Cancer (NEPC; de novo or treatment-emergent) which is&#xD;
                  relapsed/refractory to standard systemic therapy&#xD;
&#xD;
               -  High-grade neuroendocrine tumor types other than SCLC and NEPC has at least of&#xD;
                  the following:&#xD;
&#xD;
               -  Disease that is relapsed/refractory to standard systemic therapy,&#xD;
&#xD;
               -  Disease for which standard therapy does not exist, or&#xD;
&#xD;
               -  Disease for which standard therapy is not considered appropriate by the&#xD;
                  Investigator&#xD;
&#xD;
          2. Available archival tissue sample or fresh biopsy tissue sample&#xD;
&#xD;
               1. For SCLC and NEPC: must be available for shipment prior to enrollment but&#xD;
                  confirmation of DLL3 expression is not required prior to enrollment.&#xD;
&#xD;
               2. For high-grade neuroendocrine tumor types other than SCLC and NEPC: demonstration&#xD;
                  of DLL3 expression in a tumor sample is required and must be confirmed prior to&#xD;
                  screening.&#xD;
&#xD;
          3. Adequate hematologic status, including:&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) ≥1500 cells/μL&#xD;
&#xD;
               -  Platelet count ≥100,000/μL&#xD;
&#xD;
               -  Hemoglobin ≥9 g/dL (no transfusions allowed within 2 weeks prior to screening)&#xD;
&#xD;
          4. Adequate renal function, including:&#xD;
&#xD;
             • Calculated creatinine clearance ≥50 mL/min using the formula of Cockcroft and Gault&#xD;
&#xD;
          5. Adequate liver function, including&#xD;
&#xD;
               -  Total bilirubin ≤1.5 x upper limit of normal (ULN), regardless of direct&#xD;
                  bilirubin, unless the patient has documented Gilbert syndrome in which case the&#xD;
                  maximum total serum bilirubin should be 5 mg/dL&#xD;
&#xD;
               -  Aspartate and alanine transaminase (AST and ALT) ≤3 x ULN&#xD;
&#xD;
        Major Exclusion Criteria:&#xD;
&#xD;
          1. Untreated central nervous system (CNS) metastases. Patients with history of CNS&#xD;
             metastases can participate provided they are pretreated and radiologically stable&#xD;
             (i.e., without evidence of progression) for at least 2 weeks by repeated imaging&#xD;
             (note: repeated imaging should be performed during study screening), asymptomatic, and&#xD;
             without requirement of steroid treatment for at least 7 days before the first dose of&#xD;
             study treatment.&#xD;
&#xD;
          2. Patients with glioma or other primary CNS malignancy.&#xD;
&#xD;
          3. Patients with spinal cord compression or symptomatic/uncontrolled epidural disease.&#xD;
             Patients with previously treated spinal cord compression or epidural disease may be&#xD;
             eligible if stable for at least 1 week prior to first dose of study drug.&#xD;
&#xD;
          4. History of intracranial hemorrhage or spinal cord hemorrhage.&#xD;
&#xD;
          5. Active neurologic paraneoplastic syndrome.&#xD;
&#xD;
          6. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent&#xD;
             drainage procedures (e.g., biweekly or more frequently).&#xD;
&#xD;
          7. Active or history of autoimmune disease or immune deficiency, including, but not&#xD;
             limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus&#xD;
             erythematosus, rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease,&#xD;
             antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome,&#xD;
             Guillain-Barré syndrome, or multiple sclerosis. Exceptions apply.&#xD;
&#xD;
          8. Ongoing treatment with immunosuppressive medications (including, but not limited to,&#xD;
             systemic corticosteroids [prednisone dose &gt;10mg per day or equivalent],&#xD;
             cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis&#xD;
             factor [TNF] alpha agents) within 2 weeks prior to initiation of treatment, or&#xD;
             anticipation of need for systemic immunosuppressive medication during study treatment&#xD;
             (except protocol-required pre-medications). Exceptions apply.&#xD;
&#xD;
          9. History of allogeneic stem cell transplant or solid-organ transplant.&#xD;
&#xD;
         10. For patients enrolled in the HPN328/Atezolizumab combination cohorts:&#xD;
&#xD;
               -  Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary&#xD;
                  cells or any component of the atezolizumab formulation, or other anti-PD-(L)1&#xD;
                  agents.&#xD;
&#xD;
               -  Treatment with systemic immunostimulatory agents (including, but not limited to,&#xD;
                  interferon and IL-2) within 4 weeks or 5 drug-elimination half-lives (whichever&#xD;
                  is longer) prior to initiation of study treatment.&#xD;
&#xD;
               -  History of severe anaphylactic reactions to chimeric or humanized antibodies or&#xD;
                  fusion proteins.&#xD;
&#xD;
               -  History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g.,&#xD;
                  bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis,&#xD;
                  or evidence of active pneumonitis on screening chest computed tomography (CT).&#xD;
                  History of radiation pneumonitis in the radiation field is permitted.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Harpoon ClinicalTrials.gov Contact</last_name>
    <phone>(650) 452-7280</phone>
    <email>hpn328_4001ctgov@harpoontx.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christopher De Leon</last_name>
      <phone>415-307-9861</phone>
      <email>chris.deleon@ucsf.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emma Filar</last_name>
      <phone>702-848-9206</phone>
      <email>EMMA.FILAR@CUANSCHUTZ.EDU</email>
    </contact>
    <investigator>
      <last_name>Erin Schenk, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Himisha Beltran, MD</last_name>
      <phone>617-632-2429</phone>
      <email>Himisha_Beltran@DFCI.HARVARD.EDU</email>
    </contact>
    <investigator>
      <last_name>Himisha Beltran, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Center</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aaron Le</last_name>
      <phone>313-576-8912</phone>
      <email>lea@karmanos.org</email>
    </contact>
    <investigator>
      <last_name>Hirva Mamdani, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Roswell Park Comprehensive Cancer Center</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Janine Miller</last_name>
      <phone>716-845-2809</phone>
      <email>janine.miller@RoswellPark.org</email>
    </contact>
    <investigator>
      <last_name>Prantesh Jain, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Noura Choudury, MD</last_name>
      <email>choudhn2@mskcc.org</email>
    </contact>
    <investigator>
      <last_name>Noura Choudury, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cancer Information Services</last_name>
      <phone>800-641-2422</phone>
      <email>Kyle.Logue@uhhospitals.org</email>
    </contact>
    <investigator>
      <last_name>Afshin Dowlati, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>CanRsrchStudies@providence.org</email>
    </contact>
    <investigator>
      <last_name>Rachel Sanborn, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tennessee Oncology Sarah Cannon Research Institute</last_name>
      <phone>615-329-7478</phone>
      <email>cann.researchreferrals@scresearch.net</email>
    </contact>
    <investigator>
      <last_name>Melissa L. Johnson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jonathan Thompson, MD</last_name>
      <email>jrthomps@mcw.edu</email>
    </contact>
    <investigator>
      <last_name>Jonathan Thompson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 21, 2023</last_update_submitted>
  <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lung Cancer</keyword>
  <keyword>Small-Cell Lung Cancer</keyword>
  <keyword>DLL3</keyword>
  <keyword>Harpoon</keyword>
  <keyword>TriTAC</keyword>
  <keyword>Prostate Cancer</keyword>
  <keyword>Neuroendocrine Tumors</keyword>
  <keyword>High Grade Neuroendrocrine Features</keyword>
  <keyword>Delta Like Canonical Notch Ligand 3</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atezolizumab</mesh_term>
  </intervention_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/NCT04471727
org study id: HPN328-4001
nct id: NCT04471727
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety,
      Tolerability, and Pharmacokinetics of HPN328 Monotherapy and HPN328 With Atezolizumab in
      Patients With Advanced Cancers Associated With Expression of Delta-like Canonical Notch
      Ligand 3 (DLL3)
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Frequency and severity of treatment-emergent AEs (TEAEs) graded according to NCI CTACAE version 5.0 (ASTCT grading criteria for CRS and ICANS).
time frame: Up to 4 years
measure: Number and severity of DLTs following treatment with HPN328 as monotherapy or in combination with atezolizumab.
time frame: Up to 4 years
measure: PK parameters of HPN328 as monotherapy or in combination with atezolizumab.
time frame: Up to 4 years
description: Single dose - maximum concentration, time to maximum concentration, area under the single dose concentration-time curve over the dosing interval, area under the concentration-time curve extrapolated to infinity, terminal elimination half-life, and clearance as data permit
Multiple dose (assuming stead state is achieved) - maximum concentration at steady state, time to maximum concentration, area under the steady state concentration-time curve over dosing interval, terminal elimination half-life, minimum concentration, clearance, volume of distribution, and accumulation ratio as data permit.
measure: Change from baseline in selected clinical laboratory parameters, vital signs, and ECGs.
time frame: Up to 4 years
measure: Objective response rate (ORR) based on RECIST v1.1 (PCWG3 for patients with NEPC)
time frame: Up to 4 years
measure: Extra-cranial objective response rate (EC-ORR) based on modified RECIST v1.1
time frame: Up to 4 years
measure: Best Overall Response (BOR)
time frame: Up to 4 years
measure: Progression-free survival (PFS)
time frame: Up to 4 years
measure: Extra-cranial progression free survival (EC-PFS)
time frame: Up to 4 years
measure: Overall survival (OS)
time frame: Up to 4 years
measure: Duration of response (DOR)
time frame: Up to 4 years
measure: Duration of extra-cranial response (EC-DOR)
time frame: Up to 4 years
measure: Incidence and titers of ADAs against HPN328 and atezolizumab (for combination-treatment patients)
time frame: Up to 4 years
arm group label: HPN328 monotherapy dose escalation
arm group type: Experimental
description: HPN328 will be administered as a single agent once weekly via IV infusion during each 21 day cycle.
arm group label: HPN328 monotherapy dose escalation with extended dosing intervals
arm group type: Experimental
description: HPN328 will be administered as a single agent, via IV infusion either once every 2 weeks (28-day cycle), or once every 3 weeks (21-day cycle).
arm group label: HPN328 dose escalation in combination with atezolizumab
arm group type: Experimental
description: SCLC patients will be treated with a combination regimen of HPN328 and atezolizumab. HPN328 will be administered once every 2 weeks via IV infusion during each 28-day cycle. Atezolizumab will be administered once every 4 weeks via IV infusion on Day 1 of each 28-day cycle.
intervention type: Drug
intervention name: HPN328
description: HPN328 is a tri-specific recombinant protein construct (Tri-specific T Cell Activating Construct [TriTAC®]) containing 3 humanized antibody derived binding domains
arm group label: HPN328 dose escalation in combination with atezolizumab
arm group label: HPN328 monotherapy dose escalation
arm group label: HPN328 monotherapy dose escalation with extended dosing intervals
intervention type: Drug
intervention name: Atezolizumab
description: Atezolizumab is a humanized immunoglobulin (Ig) G1 monoclonal antibody which potently and selectively inhibits binding of programmed death receptor 1 ligand (PD-L1) on tumor cells and tumor infiltrating immune cells in the tumor microenvironment
arm group label: HPN328 dose escalation in combination with atezolizumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Harpoon ClinicalTrials.gov Contact
phone: (650) 452-7280
email: hpn328_4001ctgov@harpoontx.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma
mesh term: Atezolizumab