<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/NCT04449874</url>
  </required_header>
  <id_info>
    <org_study_id>GO42144</org_study_id>
    <secondary_id>2020-000084-22</secondary_id>
    <secondary_id>2023-506311-18-00</secondary_id>
    <nct_id>NCT04449874</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation</brief_title>
  <official_title>A Phase Ia/Ib Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-6036 as a Single Agent and in Combination With Other Anti-cancer Therapies in Patients With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation</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 Phase I dose-escalation and dose-expansion study that will evaluate the safety,&#xD;
      pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or&#xD;
      metastatic solid tumors with a KRAS G12C mutation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 29, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2024</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>Percentage of Participants With Adverse Events (AEs)</measure>
    <time_frame>From Cycle 1 Day 1 until 28 days after the final dose (or as specified in the protocol). A cycle is 21 days.</time_frame>
    <description>Severity is determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Dose-Limiting Toxicities (DLTs)</measure>
    <time_frame>From Cycle 1 Day 1 through Day 21. A cycle is 21 days.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentrations of GDC-6036</measure>
    <time_frame>Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentrations of Erlotinib</measure>
    <time_frame>Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentrations of GDC-1971</measure>
    <time_frame>Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentrations of Inavolisib</measure>
    <time_frame>Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)</measure>
    <time_frame>Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1</measure>
    <time_frame>Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS) as determined by the investigator according to RECIST v1.1</measure>
    <time_frame>Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship Between GDC-6036 Exposure (Maximum Plasma Concentration Observed [Cmax])</measure>
    <time_frame>Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship Between GDC-6036 Exposure (Time to Maximum Plasma Concentration [Tmax])</measure>
    <time_frame>Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship Between GDC-6036 Exposure (Half-life [t1/2])</measure>
    <time_frame>Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship Between GDC-6036 Exposure (Area Under the Curve [AUC])</measure>
    <time_frame>Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship Between Tumor Pharmacodynamic Effects of GDC-6036</measure>
    <time_frame>Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.</time_frame>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Anticipated">498</enrollment>
  <condition>Non-Small Cell Lung Cancer</condition>
  <condition>Colorectal Cancer</condition>
  <condition>Advanced Solid Tumors</condition>
  <arm_group>
    <arm_group_label>Arm A: Dose-escalation (Stage I), Dose Expansion (Stage II)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in Stage I will receive GDC-6036 administered orally once daily (PO QD). The dose will be increased in successive cohorts until a study-specific threshold is reached.&#xD;
Participants with select solid tumors will be treated with GDC-6036 PO QD in Stage II.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with non-small cell lung cancer will receive GDC-6036 in combination with atezolizumab.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C: GDC-6036 + Cetuximab (Stage I and Stage II)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with colorectal cancer will receive GDC-6036 in combination with cetuximab.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with solid tumors will receive GDC-6036 in combination with bevacizumab.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm E: GDC-6036 + Erlotinib (Stage I and Stage II)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with non-small cell lung cancer will receive GDC-6036 in combination with erlotinib.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with solid tumors will receive GDC-6036 in combination with GDC-1971 PO in Stage I.&#xD;
Participants with select solid tumors will be treated with GDC-6036 in combination with GDC-1971 PO in Stage II.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm G: GDC-6036 + Inavolisib (Stage I and Stage II)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with solid tumors will receive GDC-6036 in combination with inavolisib PO in Stage I.&#xD;
Participants with select solid tumors will be treated with GDC-6036 in combination with inavolisib PO in Stage II.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GDC-6036</intervention_name>
    <description>The starting dose of GDC-6036 in the combination Arms B, C, D, E, F and G will be determined from Stage I Arm A (single-agent dose escalation).</description>
    <arm_group_label>Arm A: Dose-escalation (Stage I), Dose Expansion (Stage II)</arm_group_label>
    <arm_group_label>Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II)</arm_group_label>
    <arm_group_label>Arm C: GDC-6036 + Cetuximab (Stage I and Stage II)</arm_group_label>
    <arm_group_label>Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II)</arm_group_label>
    <arm_group_label>Arm E: GDC-6036 + Erlotinib (Stage I and Stage II)</arm_group_label>
    <arm_group_label>Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II)</arm_group_label>
    <arm_group_label>Arm G: GDC-6036 + Inavolisib (Stage I and Stage II)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <description>A 1200 milligram (mg) intravenous (IV) infusion of atezolizumab will be administered on Day 1 of 21 day cycles.</description>
    <arm_group_label>Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cetuximab</intervention_name>
    <description>Cetuximab will be administered at an initial dose of 400 milligram per square meter (mg/m^2) IV infusion followed by 250 mg/m^2 IV infusion weekly in 21 day cycles.</description>
    <arm_group_label>Arm C: GDC-6036 + Cetuximab (Stage I and Stage II)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevacizumab</intervention_name>
    <description>A 15 milligram per kilogram (mg/kg) IV infusion of bevacizumab will be administered on Day 1 of 21 day cycles.</description>
    <arm_group_label>Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erlotinib</intervention_name>
    <description>150 mg of erlotinib will be administered PO QD in 21 day cycles.</description>
    <arm_group_label>Arm E: GDC-6036 + Erlotinib (Stage I and Stage II)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GDC-1971</intervention_name>
    <description>The starting dose of GDC-1971 will be determined from its single-agent dose escalation.</description>
    <arm_group_label>Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Inavolisib</intervention_name>
    <description>The starting dose of inavolisib will be determined from its single-agent dose escalation.</description>
    <arm_group_label>Arm G: GDC-6036 + Inavolisib (Stage I and Stage II)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation.&#xD;
&#xD;
          -  Women of childbearing potential must agree to remain abstinent or use contraception,&#xD;
             and agree to refrain from donating eggs during the treatment period and after the&#xD;
             final dose of study treatment as specified in the protocol.&#xD;
&#xD;
          -  Men who are not surgically sterile must agree to remain abstinent or use a condom, and&#xD;
             agreement to refrain from donating sperm during the treatment period and after the&#xD;
             final dose of study treatment as specified in the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active brain metastases.&#xD;
&#xD;
          -  Malabsorption or other condition that interferes with enteral absorption.&#xD;
&#xD;
          -  Clinically significant cardiovascular dysfunction or liver 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>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Genentech, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Reference Study ID Number: GO42144 whttps://forpatients.roche.com/</last_name>
    <phone>888-662-6728 (U.S. and Canada)</phone>
    <email>global-roche-genentech-trials@gene.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>City of Hope Comprehensive Cancer Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UCSD Moores Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chao Family Comprehensive Cancer Center UCI</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Univ of Calif, San Francisco; Breast Cancer Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Yale Cancer Center</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists - Sarasota</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>11101</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma; Stephenson Oklahoma Canc Ctr</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Abramson Cancer Center; Univ of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UPMC - Hillman Cancer Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital Sydney</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Slade Health Inward goods</name>
      <address>
        <city>Mount Kuring-gai</city>
        <state>New South Wales</state>
        <zip>2080</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Alfred Health</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Peter MacCallum Cancer Center</name>
      <address>
        <city>North Melbourne</city>
        <state>Victoria</state>
        <zip>3051</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Linear Clinical Research Limited</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UZ Antwerpen</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU de Liège</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AZ St Maarten Campus Leopoldstr</name>
      <address>
        <city>Mechelen</city>
        <zip>2800</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Santa Casa de Misericórdia de Belo Horizonte - PPDS</name>
      <address>
        <city>Belo Horizonte</city>
        <state>MG</state>
        <zip>30150-221</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital de Clinicas de Porto Alegre (HCPA) - PPDS</name>
      <address>
        <city>Porto Alegre</city>
        <state>PA</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Erasto Gaertner</name>
      <address>
        <city>Curitiba</city>
        <state>PR</state>
        <zip>81520-060</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Câncer</name>
      <address>
        <city>Rio de Janeiro</city>
        <state>RJ</state>
        <zip>20230-130</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universidade de Caxias do Sul</name>
      <address>
        <city>Caxias Do Sul</city>
        <state>RS</state>
        <zip>95070-561</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90610-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital de Cancer de Barretos</name>
      <address>
        <city>Barretos</city>
        <state>SP</state>
        <zip>14784-400</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS</name>
      <address>
        <city>Sao Jose Do Rio Preto</city>
        <state>SP</state>
        <zip>15090-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital; Sir Mortimer B. Davis</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2W 1S6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Semmelweis Egyetem</name>
      <address>
        <city>Budapest</city>
        <zip>1088</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinexpert Kft. - Gyongyos</name>
      <address>
        <city>Gyongyos</city>
        <zip>3200</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rambam Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center - PPDS</name>
      <address>
        <city>Ramat-Gan</city>
        <zip>5262000</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tel-Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS</name>
      <address>
        <city>Meldola</city>
        <state>Emilia-Romagna</state>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Irccs Ospedale San Raffaele;Oncologia Medica</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Asst Grande Ospedale Metropolitano Niguarda</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas</name>
      <address>
        <city>Rozzano (MI)</city>
        <state>Lombardia</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Pisana</name>
      <address>
        <city>Pisa</city>
        <state>Toscana</state>
        <zip>56126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Aga Khan University Hospital</name>
      <address>
        <city>Nairobi</city>
        <zip>00100</zip>
        <country>Kenya</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center - PPDS</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center - PPDS</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis</name>
      <address>
        <city>Amsterdam</city>
        <zip>1066 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Leids Universitair Medisch Centrum</name>
      <address>
        <city>Leiden</city>
        <zip>2333 ZA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitair Medisch Centrum Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital, Cancer and Blood Research</name>
      <address>
        <city>Auckland</city>
        <zip>1023</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Auckland</city>
        <zip>1023</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>New Zealand Clinical Research - Christchurch</name>
      <address>
        <city>Christchurch</city>
        <zip>8011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Haukeland University Hospital; Hospital Pharmacy</name>
      <address>
        <city>Bergen</city>
        <zip>5053</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Oslo university hospital Radiumhospitalet</name>
      <address>
        <city>Oslo</city>
        <zip>0424</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Medical University of Gdansk</name>
      <address>
        <city>Gdansk</city>
        <zip>80-952</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Biokinetica, Przychodnia Jozefow</name>
      <address>
        <city>Jozefow</city>
        <zip>05-410</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny w Poznaniu</name>
      <address>
        <city>Pozna?</city>
        <zip>60-780</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic</name>
      <address>
        <city>Kazan</city>
        <state>Tatarstan</state>
        <zip>420029</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>START Madrid-FJD, Hospital Fundacion Jimenez Diaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario HM Sanchinarro-CIOCC</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Virgen de la Victoria</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocío</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsspital Basel; Onkologie</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Inselspital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Genève</name>
      <address>
        <city>Genève</city>
        <zip>1211</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Unversitätsspital Zürich</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Velindre Cancer Centre</name>
      <address>
        <city>Cardiff</city>
        <zip>CF14 2TL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility</name>
      <address>
        <city>London</city>
        <zip>W1T 7HA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Christie NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Kenya</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>France</country>
    <country>Germany</country>
  </removed_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>KRAS G12C</keyword>
  <keyword>Non-Small Cell Lung Cancer</keyword>
  <keyword>Colorectal Cancer</keyword>
  <keyword>GDC-6036</keyword>
  <keyword>Metastatic Solid Tumor</keyword>
  <keyword>Atezolizumab</keyword>
  <keyword>Bevacizumab</keyword>
  <keyword>Cetuximab</keyword>
  <keyword>Erlotinib</keyword>
  <keyword>Inavolisib</keyword>
  <keyword>GDC-1971</keyword>
  <keyword>SHP2</keyword>
  <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>Bevacizumab</mesh_term>
    <mesh_term>Cetuximab</mesh_term>
    <mesh_term>Atezolizumab</mesh_term>
    <mesh_term>Erlotinib Hydrochloride</mesh_term>
    <mesh_term>Inavolisib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/members/ourmembers/). 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>


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/NCT04449874
org study id: GO42144
secondary id: 2020-000084-22
secondary id: 2023-506311-18-00
nct id: NCT04449874
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety,
      pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or
      metastatic solid tumors with a KRAS G12C mutation.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Adverse Events (AEs)
time frame: From Cycle 1 Day 1 until 28 days after the final dose (or as specified in the protocol). A cycle is 21 days.
description: Severity is determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
measure: Percentage of Participants With Dose-Limiting Toxicities (DLTs)
time frame: From Cycle 1 Day 1 through Day 21. A cycle is 21 days.
measure: Plasma Concentrations of GDC-6036
time frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
measure: Plasma Concentrations of Erlotinib
time frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
measure: Plasma Concentrations of GDC-1971
time frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
measure: Plasma Concentrations of Inavolisib
time frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
measure: Objective Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
time frame: Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
measure: Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1
time frame: Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
measure: Progression-free survival (PFS) as determined by the investigator according to RECIST v1.1
time frame: Every 6 weeks from Cycle 1 Day 1 until study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
measure: Relationship Between GDC-6036 Exposure (Maximum Plasma Concentration Observed [Cmax])
time frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
measure: Relationship Between GDC-6036 Exposure (Time to Maximum Plasma Concentration [Tmax])
time frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
measure: Relationship Between GDC-6036 Exposure (Half-life [t1/2])
time frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
measure: Relationship Between GDC-6036 Exposure (Area Under the Curve [AUC])
time frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
measure: Relationship Between Tumor Pharmacodynamic Effects of GDC-6036
time frame: Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (within 28 days after the final dose of study drug). A cycle is 21 days.
arm group label: Arm A: Dose-escalation (Stage I), Dose Expansion (Stage II)
arm group type: Experimental
description: Participants in Stage I will receive GDC-6036 administered orally once daily (PO QD). The dose will be increased in successive cohorts until a study-specific threshold is reached.
Participants with select solid tumors will be treated with GDC-6036 PO QD in Stage II.
arm group label: Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II)
arm group type: Experimental
description: Participants with non-small cell lung cancer will receive GDC-6036 in combination with atezolizumab.
arm group label: Arm C: GDC-6036 + Cetuximab (Stage I and Stage II)
arm group type: Experimental
description: Participants with colorectal cancer will receive GDC-6036 in combination with cetuximab.
arm group label: Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II)
arm group type: Experimental
description: Participants with solid tumors will receive GDC-6036 in combination with bevacizumab.
arm group label: Arm E: GDC-6036 + Erlotinib (Stage I and Stage II)
arm group type: Experimental
description: Participants with non-small cell lung cancer will receive GDC-6036 in combination with erlotinib.
arm group label: Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II)
arm group type: Experimental
description: Participants with solid tumors will receive GDC-6036 in combination with GDC-1971 PO in Stage I.
Participants with select solid tumors will be treated with GDC-6036 in combination with GDC-1971 PO in Stage II.
arm group label: Arm G: GDC-6036 + Inavolisib (Stage I and Stage II)
arm group type: Experimental
description: Participants with solid tumors will receive GDC-6036 in combination with inavolisib PO in Stage I.
Participants with select solid tumors will be treated with GDC-6036 in combination with inavolisib PO in Stage II.
intervention type: Drug
intervention name: GDC-6036
description: The starting dose of GDC-6036 in the combination Arms B, C, D, E, F and G will be determined from Stage I Arm A (single-agent dose escalation).
arm group label: Arm A: Dose-escalation (Stage I), Dose Expansion (Stage II)
arm group label: Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II)
arm group label: Arm C: GDC-6036 + Cetuximab (Stage I and Stage II)
arm group label: Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II)
arm group label: Arm E: GDC-6036 + Erlotinib (Stage I and Stage II)
arm group label: Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II)
arm group label: Arm G: GDC-6036 + Inavolisib (Stage I and Stage II)
intervention type: Drug
intervention name: Atezolizumab
description: A 1200 milligram (mg) intravenous (IV) infusion of atezolizumab will be administered on Day 1 of 21 day cycles.
arm group label: Arm B: GDC-6036 + Atezolizumab (Stage I and Stage II)
intervention type: Drug
intervention name: Cetuximab
description: Cetuximab will be administered at an initial dose of 400 milligram per square meter (mg/m^2) IV infusion followed by 250 mg/m^2 IV infusion weekly in 21 day cycles.
arm group label: Arm C: GDC-6036 + Cetuximab (Stage I and Stage II)
intervention type: Drug
intervention name: Bevacizumab
description: A 15 milligram per kilogram (mg/kg) IV infusion of bevacizumab will be administered on Day 1 of 21 day cycles.
arm group label: Arm D: GDC-6036 + Bevacizumab (Stage I and Stage II)
intervention type: Drug
intervention name: Erlotinib
description: 150 mg of erlotinib will be administered PO QD in 21 day cycles.
arm group label: Arm E: GDC-6036 + Erlotinib (Stage I and Stage II)
intervention type: Drug
intervention name: GDC-1971
description: The starting dose of GDC-1971 will be determined from its single-agent dose escalation.
arm group label: Arm F: GDC-6036 + GDC-1971 (Stage I and Stage II)
intervention type: Drug
intervention name: Inavolisib
description: The starting dose of inavolisib will be determined from its single-agent dose escalation.
arm group label: Arm G: GDC-6036 + Inavolisib (Stage I and Stage II)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Genentech, Inc.
last name: Reference Study ID Number: GO42144 whttps://forpatients.roche.com/
phone: 888-662-6728 (U.S. and Canada)
email: global-roche-genentech-trials@gene.com
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Australia
country: Belgium
country: Brazil
country: Canada
country: Hungary
country: Israel
country: Italy
country: Kenya
country: Korea, Republic of
country: Netherlands
country: New Zealand
country: Norway
country: Poland
country: Russian Federation
country: Spain
country: Switzerland
country: United Kingdom
country: United States
country: France
country: Germany
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Colorectal Neoplasms
mesh term: Bevacizumab
mesh term: Cetuximab
mesh term: Atezolizumab
mesh term: Erlotinib Hydrochloride
mesh term: Inavolisib
sharing ipd: No
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/members/ourmembers/). 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).