xml: <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/NCT06031441</url>
    </required_header>
    <id_info>
      <org_study_id>GO44431</org_study_id>
      <nct_id>NCT06031441</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors</brief_title>
    <official_title>A Phase I, Open-Label, Multicenter, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Genentech, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Genentech, Inc.</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 first-in-human Phase I, open-label, dose-escalation and expansion study designed to&#xD;
        evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and&#xD;
        preliminary anti-tumor activity of RO7566802 as a single agent and in combination with&#xD;
        atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid&#xD;
        tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants with DLTs</measure>
      <time_frame>Cycle 1 Day 1 through 21 days after Cycle 2 Day 1 (Cycle length=21 days) (up to approximately 42 days)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of Participants with Adverse Events (AEs) Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)</measure>
      <time_frame>Up to approximately 39 months</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Area Under the Serum Concentration Time Curve (AUC) of RO7566802</measure>
      <time_frame>Up to approximately 39 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum Serum Concentration (Cmax) of RO7566802</measure>
      <time_frame>Up to approximately 39 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Minimum Serum Concentration (Cmin) of RO7566802</measure>
      <time_frame>Up to approximately 39 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total Clearance (CL) of RO7566802</measure>
      <time_frame>Up to approximately 39 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Volume of Distribution at Steady State (Vss) of RO7566802</measure>
      <time_frame>Up to approximately 39 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum Concentration of Atezolizumab</measure>
      <time_frame>Up to approximately 39 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective Response Rate as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)</measure>
      <time_frame>Up to approximately 39 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7566802</measure>
      <time_frame>From Baseline up to approximately 39 months</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Locally Advanced Solid Tumors</condition>
    <condition>Recurrent Solid Tumors</condition>
    <condition>Metastatic Solid Tumors</condition>
    <arm_group>
      <arm_group_label>Dose Escalation Cohort</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in successive cohorts will receive escalating doses of RO7566802, as an intravenous (IV) infusion on Day 1 of each 21-day cycle followed by RO7566802 in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dose Expansion Cohort</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with select solid tumors will receive a recommended dose of RO7566802, determined in Dose Escalation phase, as an IV infusion in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>RO7566802</intervention_name>
      <description>RO7566802 solution for infusion will be administered as specified in each treatment arm.</description>
      <arm_group_label>Dose Escalation Cohort</arm_group_label>
      <arm_group_label>Dose Expansion Cohort</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Atezolizumab</intervention_name>
      <description>Atezolizumab solution for infusion will be administered as specified in each treatment arm.</description>
      <arm_group_label>Dose Escalation Cohort</arm_group_label>
      <arm_group_label>Dose Expansion Cohort</arm_group_label>
      <other_name>Tecentriq®</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1&#xD;
  &#xD;
            -  Life expectancy &gt;=3 months, in the investigator's judgment&#xD;
  &#xD;
            -  Adequate hematologic and end-organ function&#xD;
  &#xD;
            -  Histologically confirmed locally advanced, recurrent, or metastatic incurable solid&#xD;
               tumor malignancy&#xD;
  &#xD;
            -  Measurable disease per RECIST v1.1&#xD;
  &#xD;
            -  Disease that has progressed after at least one available standard therapy, and for&#xD;
               which standard therapy has proven to be ineffective or intolerable or is considered&#xD;
               inappropriate, or for which a clinical trial of an investigational agent is a&#xD;
               recognized standard of care&#xD;
  &#xD;
            -  Tumor specimen availability, for certain cohorts&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any anti-cancer therapy, whether investigational or approved, including chemotherapy,&#xD;
               hormonal therapy, or radiotherapy, within 3 weeks prior to C1D1, with certain&#xD;
               exceptions&#xD;
  &#xD;
            -  Active hepatitis B or C&#xD;
  &#xD;
            -  Active tuberculosis&#xD;
  &#xD;
            -  Positive test for HIV infection&#xD;
  &#xD;
            -  Administration of a live, attenuated vaccine (e.g., Flumist) within 4 weeks prior to&#xD;
               RO7566802 infusion&#xD;
  &#xD;
            -  Symptomatic, untreated, or actively progressing central nervous system (CNS)&#xD;
               metastases&#xD;
  &#xD;
            -  Active or history of autoimmune disease&#xD;
  &#xD;
            -  Prior allogeneic stem cell or organ transplantation&#xD;
  &#xD;
            -  Uncontrolled tumor-related pain&#xD;
  &#xD;
            -  Significant cardiovascular disease&#xD;
  &#xD;
          Other protocol-defined inclusion/exclusion criteria may apply.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Clinical Trials</last_name>
      <role>Study Director</role>
      <affiliation>Hoffmann-La Roche</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Reference Study ID Number: GO44431 https://forpatients.roche.com/</last_name>
      <phone>888-662-6728 (U.S. Only)</phone>
      <email>global-roche-genentech-trials@gene.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 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>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>Yes</sharing_ipd>
      <ipd_description>Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06031441
  org study id: GO44431
  nct id: NCT06031441
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a first-in-human Phase I, open-label, dose-escalation and expansion study designed to
        evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and
        preliminary anti-tumor activity of RO7566802 as a single agent and in combination with
        atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid
        tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of Participants with DLTs
  time frame: Cycle 1 Day 1 through 21 days after Cycle 2 Day 1 (Cycle length=21 days) (up to approximately 42 days)
  measure: Percentage of Participants with Adverse Events (AEs) Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
  time frame: Up to approximately 39 months
  measure: Area Under the Serum Concentration Time Curve (AUC) of RO7566802
  time frame: Up to approximately 39 months
  measure: Maximum Serum Concentration (Cmax) of RO7566802
  time frame: Up to approximately 39 months
  measure: Minimum Serum Concentration (Cmin) of RO7566802
  time frame: Up to approximately 39 months
  measure: Total Clearance (CL) of RO7566802
  time frame: Up to approximately 39 months
  measure: Volume of Distribution at Steady State (Vss) of RO7566802
  time frame: Up to approximately 39 months
  measure: Serum Concentration of Atezolizumab
  time frame: Up to approximately 39 months
  measure: Objective Response Rate as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
  time frame: Up to approximately 39 months
  measure: Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7566802
  time frame: From Baseline up to approximately 39 months
  arm group label: Dose Escalation Cohort
  arm group type: Experimental
  description: Participants in successive cohorts will receive escalating doses of RO7566802, as an intravenous (IV) infusion on Day 1 of each 21-day cycle followed by RO7566802 in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
  arm group label: Dose Expansion Cohort
  arm group type: Experimental
  description: Participants with select solid tumors will receive a recommended dose of RO7566802, determined in Dose Escalation phase, as an IV infusion in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
  intervention type: Drug
  intervention name: RO7566802
  description: RO7566802 solution for infusion will be administered as specified in each treatment arm.
  arm group label: Dose Escalation Cohort
  arm group label: Dose Expansion Cohort
  intervention type: Drug
  intervention name: Atezolizumab
  description: Atezolizumab solution for infusion will be administered as specified in each treatment arm.
  arm group label: Dose Escalation Cohort
  arm group label: Dose Expansion Cohort
  other name: Tecentriq®
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Clinical Trials
  role: Study Director
  affiliation: Hoffmann-La Roche
  last name: Reference Study ID Number: GO44431 https://forpatients.roche.com/
  phone: 888-662-6728 (U.S. Only)
  email: global-roche-genentech-trials@gene.com
  responsible party type: Sponsor
  mesh term: Neoplasms
  mesh term: Atezolizumab
  sharing ipd: Yes
  ipd description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).