<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/NCT03296696</url>
  </required_header>
  <id_info>
    <org_study_id>20160132</org_study_id>
    <secondary_id>2017-001658-32</secondary_id>
    <nct_id>NCT03296696</nct_id>
  </id_info>
  <brief_title>Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma</brief_title>
  <official_title>Phase 1/1b Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 596 as Monotherapy and in Combination With AMG 404 in Subjects With Glioblastoma or Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1/1b Study to Evaluate Safety, Tolerability, Pharmacokinetics and&#xD;
      Pharmacodynamics of AMG 596 monotherapy or in combination with AMG 404 in Subjects with&#xD;
      Glioblastoma or Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant&#xD;
      III (EGFRvIII).&#xD;
&#xD;
      This is a first in human (FIH), open-label, sequential-dose-escalation study in subjects with&#xD;
      EGFRvIII-positive glioblastoma or malignant glioma. This study will enroll 2 groups of&#xD;
      subjects according to disease stage, recurrent disease (Group 1) and maintenance treatment&#xD;
      after SoC in newly diagnosed disease (Group 2).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 18, 2018</start_date>
  <completion_date type="Actual">August 28, 2021</completion_date>
  <primary_completion_date type="Actual">July 1, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Bayesian logistic regression model</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subject grade of dose limiting toxicities (DTLs)</measure>
    <time_frame>12 months</time_frame>
    <description>Subject grade of dose limiting toxicities is the occurrence of any of the toxicities during the DLT evaluation period if judged by the investigator to be related to the administration of AMG 596 and AMG 404</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subject with treatment-emergent adverse events</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with treatment-related adverse events</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant changes in vital signs</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant changes in physical examinations</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinically significant changes in clinical laboratory tests</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average steady-state concentration (Css) for serum AMG 596</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve (AUC) for serum AMG 596</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance for serum AMG 596</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution for serum AMG 596</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half-life (t1/2) for serum AMG 596</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum abserved serum concentration (Cmax) for AMG 404</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to achieve Cmax (tmax) for AMG 404</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve (AUC) for AMG 404</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average steady-state concentration (Css) for serum AMG 596 in combination with AMG 404</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve (AUC) for serum AMG 596 in combination with AMG 404</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance for serum AMG 596 in combination with AMG 404</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half-life (t1/2) for serum AMG 596 in combination with AMG 404</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response (OR) as per modified RANO for AMG 596</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Objective response (OR) as per modified RANO (Response Assessment in Neuro-Oncology Criteria).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to response for serum AMG 596 in combination with AMG 404</measure>
    <time_frame>6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response duration for serum AMG 596 in combination with AMG 404</measure>
    <time_frame>6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to progression (TTP) for serum AMG 596 in combination with AMG 404</measure>
    <time_frame>6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS) at 6 and 12 months after treatment initiation with AMG 596 monotherapy</measure>
    <time_frame>6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS) at 6 and 12 months after treatment initiation with AMG 596 in combination with AMG 404</measure>
    <time_frame>6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response (OR) as per modified RANO with AMG 596 monotherapy</measure>
    <time_frame>6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to response with AMG 596 monotherapy</measure>
    <time_frame>6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response duration with AMG 596 monotherapy</measure>
    <time_frame>6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to progression (TTP) with AMG 596 monotherapy</measure>
    <time_frame>6 and 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Glioblastoma or Malignant Glioma</condition>
  <arm_group>
    <arm_group_label>Dose exploration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose exploration of the intervention, AMG 596 alone or in combination with AMG 404</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose expansion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose expansion of the intervention, AMG 596 alone or in combination with AMG 404</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AMG 596</intervention_name>
    <description>Drug</description>
    <arm_group_label>Dose expansion</arm_group_label>
    <arm_group_label>Dose exploration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AMG 404</intervention_name>
    <description>Drug</description>
    <arm_group_label>Dose expansion</arm_group_label>
    <arm_group_label>Dose exploration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG, Appendix G) Performance Status of less than&#xD;
             or equal to 1&#xD;
&#xD;
          -  Life expectancy of at least 3 months, in the opinion of the investigator.&#xD;
&#xD;
          -  Must have pathologically documented, and definitively diagnosed World Health&#xD;
             Organization (WHO) grade 4, glioblastoma or lower grade malignant gliomas with&#xD;
             EGFRvIII positive tumor&#xD;
&#xD;
          -  Must have recurrent disease confirmed by MRI (Group 1) or completed SoC therapy such&#xD;
             as surgery with adjuvant radiochemotherapy with or without maintenance temozolomide&#xD;
             according to local standards for newly diagnosed disease (Group 2)&#xD;
&#xD;
          -  Hematological function as follows:&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) greater than 1500/mm3 (1.5 × 10 9/L)&#xD;
&#xD;
               -  Platelet count greater than 100,000 mm3 (100 × 10 9/L)&#xD;
&#xD;
               -  White blood cell (WBC) count greater than 3 × 10 9/L&#xD;
&#xD;
               -  Hemoglobin greater than 9.0 g/dL&#xD;
&#xD;
          -  Renal function as follows: serum creatinine less than 2.0 mg/dL and estimated&#xD;
             glomerular filtration rate greater than or equal to 60 mL/min/1.73 m2 by MDRD and&#xD;
             urine protein quantitative value of less than 30 mg/dL in urinalysis or less than or&#xD;
             equal to 1+ on dipstick&#xD;
&#xD;
          -  Hepatic function as follows:&#xD;
&#xD;
               -  Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) less than or&#xD;
                  equal to 3.0 x upper limit of normal (ULN)&#xD;
&#xD;
               -  Bilirubin less than or equal to 1.5 x ULN (unless considered due to Gilbert's&#xD;
                  syndrome or hemolysis)&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  History or evidence of central nervous system bleeding as defined by stroke or&#xD;
             intraocular bleed (including embolic stroke) not associated with any antitumor surgery&#xD;
             within 6 months before enrolment&#xD;
&#xD;
          -  Known hypersensitivity to immunoglobulins or to any other component of the IP&#xD;
             formulation&#xD;
&#xD;
          -  Active infection requiring intravenous antibiotics that was completed less than 1 week&#xD;
             of study enrolment (day 1) with the exemption of prophylactic antibiotics for long&#xD;
             line insertion or biopsy&#xD;
&#xD;
          -  Known positive test for human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Active hepatitis B and C based on the following results:&#xD;
&#xD;
               -  Positive for hepatitis B surface antigen (HepBsAg) (indicative of chronic&#xD;
                  hepatitis B or recent acute hepatitis B)&#xD;
&#xD;
               -  Negative HepBsAg and positive for hepatitis B core antibody: hepatitis B virus&#xD;
                  DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus&#xD;
                  DNA suggests occult hepatitis B&#xD;
&#xD;
               -  Positive hepatitis C virus antibody (HepCAb): hepatitis C virus RNA by PCR is&#xD;
                  necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C&#xD;
&#xD;
          -  Unresolved toxicities from prior antitumor therapy, defined as not having resolved to&#xD;
             CTCAE, version 4.0 grade 1 (with the exception of myelosuppression, eg, neutropenia,&#xD;
             anemia, thrombocytopenia), or to levels dictated in the eligibility criteria with the&#xD;
             exception of alopecia or toxicities from prior antitumor therapy that are considered&#xD;
             irreversible (defined as having been present and stable for greater than 2 months)&#xD;
             which may be allowed if they are not otherwise described in the exclusion criteria AND&#xD;
             there is agreement to allow by both the investigator and sponsor&#xD;
&#xD;
          -  Antitumor therapy (chemotherapy, antibody therapy, molecular-targeted therapy, or&#xD;
             investigational agent) within 14 days (Group 2 subjects) or 5 half-lives (whichever is&#xD;
             longer: for Group 1 subjects) of day 1. Avastin, Pembrolizumab must be stopped 14 days&#xD;
             prior to day 1&#xD;
&#xD;
          -  Female with a positive pregnancy test.&#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_official>
    <last_name>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal North SHore Hospital</name>
      <address>
        <city>St Leonards</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peter MacCallum Cancer Centre</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <zip>94800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UniversitÃ¤tsklinikum Carl Gustav Carus der Technischen UniversitÃ¤t Dresden</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Wuerzburg</name>
      <address>
        <city>WÃ¼rzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vrije Universiteit Medisch Centrum</name>
      <address>
        <city>Amsterdam</city>
        <zip>1081 HV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <state>CataluÃ±a</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <reference>
    <citation>Sternjak A, Lee F, Thomas O, Balazs M, Wahl J, Lorenczewski G, Ullrich I, Muenz M, Rattel B, Bailis JM, Friedrich M. Preclinical Assessment of AMG 596, a Bispecific T-cell Engager (BiTE) Immunotherapy Targeting the Tumor-specific Antigen EGFRvIII. Mol Cancer Ther. 2021 May;20(5):925-933. doi: 10.1158/1535-7163.MCT-20-0508. Epub 2021 Feb 25.</citation>
    <PMID>33632870</PMID>
  </reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>December 21, 2021</last_update_submitted>
  <last_update_submitted_qc>December 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Phase 1/1b</keyword>
  <keyword>EGFRvIII-positive glioblastoma or malignant glioma</keyword>
  <keyword>safety and tolerability</keyword>
  <keyword>AMG 596</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</mesh_term>
    <mesh_term>Glioma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.</ipd_access_criteria>
    <ipd_url>https://www.amgen.com/datasharing</ipd_url>
  </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/NCT03296696
org study id: 20160132
secondary id: 2017-001658-32
nct id: NCT03296696
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 1/1b Study to Evaluate Safety, Tolerability, Pharmacokinetics and
      Pharmacodynamics of AMG 596 monotherapy or in combination with AMG 404 in Subjects with
      Glioblastoma or Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant
      III (EGFRvIII).

      This is a first in human (FIH), open-label, sequential-dose-escalation study in subjects with
      EGFRvIII-positive glioblastoma or malignant glioma. This study will enroll 2 groups of
      subjects according to disease stage, recurrent disease (Group 1) and maintenance treatment
      after SoC in newly diagnosed disease (Group 2).
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Bayesian logistic regression model
primary purpose: Treatment
masking: None (Open Label)
measure: Subject grade of dose limiting toxicities (DTLs)
time frame: 12 months
description: Subject grade of dose limiting toxicities is the occurrence of any of the toxicities during the DLT evaluation period if judged by the investigator to be related to the administration of AMG 596 and AMG 404
measure: Number of subject with treatment-emergent adverse events
time frame: 12 months
measure: Number of subjects with treatment-related adverse events
time frame: 12 months
measure: Number of subjects with clinically significant changes in vital signs
time frame: 12 months
measure: Number of subjects with clinically significant changes in physical examinations
time frame: 12 months
measure: Number of subjects with clinically significant changes in clinical laboratory tests
time frame: 12 months
measure: Average steady-state concentration (Css) for serum AMG 596
time frame: 12 months
measure: Area under the concentration-time curve (AUC) for serum AMG 596
time frame: 12 months
measure: Clearance for serum AMG 596
time frame: 12 months
measure: Volume of distribution for serum AMG 596
time frame: 12 months
measure: Half-life (t1/2) for serum AMG 596
time frame: 12 months
measure: Maximum abserved serum concentration (Cmax) for AMG 404
time frame: 12 months
measure: Time to achieve Cmax (tmax) for AMG 404
time frame: 12 months
measure: Area under the concentration-time curve (AUC) for AMG 404
time frame: 12 months
measure: Average steady-state concentration (Css) for serum AMG 596 in combination with AMG 404
time frame: 12 months
measure: Area under the concentration-time curve (AUC) for serum AMG 596 in combination with AMG 404
time frame: 12 months
measure: Clearance for serum AMG 596 in combination with AMG 404
time frame: 12 months
measure: Half-life (t1/2) for serum AMG 596 in combination with AMG 404
time frame: 12 months
measure: Objective response (OR) as per modified RANO for AMG 596
time frame: 6 and 12 months
description: Objective response (OR) as per modified RANO (Response Assessment in Neuro-Oncology Criteria).
measure: Time to response for serum AMG 596 in combination with AMG 404
time frame: 6 and 12 months
measure: Response duration for serum AMG 596 in combination with AMG 404
time frame: 6 and 12 months
measure: Time to progression (TTP) for serum AMG 596 in combination with AMG 404
time frame: 6 and 12 months
measure: Progression free survival (PFS) at 6 and 12 months after treatment initiation with AMG 596 monotherapy
time frame: 6 and 12 months
measure: Progression free survival (PFS) at 6 and 12 months after treatment initiation with AMG 596 in combination with AMG 404
time frame: 6 and 12 months
measure: Objective response (OR) as per modified RANO with AMG 596 monotherapy
time frame: 6 and 12 months
measure: Time to response with AMG 596 monotherapy
time frame: 6 and 12 months
measure: Response duration with AMG 596 monotherapy
time frame: 6 and 12 months
measure: Time to progression (TTP) with AMG 596 monotherapy
time frame: 6 and 12 months
arm group label: Dose exploration
arm group type: Experimental
description: Dose exploration of the intervention, AMG 596 alone or in combination with AMG 404
arm group label: Dose expansion
arm group type: Experimental
description: Dose expansion of the intervention, AMG 596 alone or in combination with AMG 404
intervention type: Drug
intervention name: AMG 596
description: Drug
arm group label: Dose expansion
arm group label: Dose exploration
intervention type: Drug
intervention name: AMG 404
description: Drug
arm group label: Dose expansion
arm group label: Dose exploration
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: France
country: Germany
country: Netherlands
country: Spain
country: United States
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
citation: Sternjak A, Lee F, Thomas O, Balazs M, Wahl J, Lorenczewski G, Ullrich I, Muenz M, Rattel B, Bailis JM, Friedrich M. Preclinical Assessment of AMG 596, a Bispecific T-cell Engager (BiTE) Immunotherapy Targeting the Tumor-specific Antigen EGFRvIII. Mol Cancer Ther. 2021 May;20(5):925-933. doi: 10.1158/1535-7163.MCT-20-0508. Epub 2021 Feb 25.
PMID: 33632870
responsible party type: Sponsor
mesh term: Glioblastoma
mesh term: Glioma
sharing ipd: Yes
ipd description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
ipd access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
ipd url: https://www.amgen.com/datasharing