<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/NCT02219724</url>
  </required_header>
  <id_info>
    <org_study_id>GO29313</org_study_id>
    <secondary_id>2014-001474-34</secondary_id>
    <nct_id>NCT02219724</nct_id>
  </id_info>
  <brief_title>A Study to Assess Safety and Pharmacokinetics of MOXR0916 in Participants With Locally Advanced or Metastatic Solid Tumors</brief_title>
  <official_title>A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MOXR0916 Administered Intravenously as a Single Agent to 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>
  <brief_summary>
    <textblock>
      This is a first-in-human, Phase 1, open-label, multicenter, dose-escalation study designed to&#xD;
      evaluate the safety, tolerability, and pharmacokinetics of MOXR0916 administered&#xD;
      intravenously in participants with locally advanced or metastatic solid tumors that have&#xD;
      progressed after all available standard therapy or for which standard therapy has proven to&#xD;
      be ineffective or intolerable, or is considered inappropriate. This study will consist of a&#xD;
      screening period, an initial treatment period, a re-treatment period (for participants who&#xD;
      discontinue MOXR0916 after demonstration of prolonged clinical benefit), and a post-treatment&#xD;
      follow-up period. Participants will be enrolled in two stages: a dose-escalation stage and an&#xD;
      expansion stage. The planned duration of the study is approximately 3 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 12, 2014</start_date>
  <completion_date type="Actual">August 18, 2019</completion_date>
  <primary_completion_date type="Actual">July 14, 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Dose Limiting Toxicities (DLTs)</measure>
    <time_frame>Day 1 Up to Day 21 or 42</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Adverse Events (AEs) by Severity as Graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0)</measure>
    <time_frame>Baseline up to 90 days after the last dose of study treatment, or until the initiation of another systemic anti-cancer therapy, whichever occurs first (approximately up to 3 years)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Tolerated Dose (MTD) of MOXR0916</measure>
    <time_frame>Baseline up to 21 to 42 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recommended Phase II Dose of MOXR0916</measure>
    <time_frame>Baseline up to 21 to 42 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Anti-MOXR0916 Antibodies</measure>
    <time_frame>Pre-dose (Hour [Hr] 0) on Day (D) 1 of Cycles (Cy) 1,2,3,4,8,12,16, &amp; then every 8 Cy up to treatment discontinuation visit (TDV) (up to approximately 3 years) (1 Cy=21 days), thereafter every 30 days for up to 120 days after treatment discontinuation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Cycles of MOXR0916 Treatment Received</measure>
    <time_frame>Baseline up to approximately 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean MOXR0916 Dose Administered During Study</measure>
    <time_frame>Baseline up to approximately 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Serum Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of MOXR0916</measure>
    <time_frame>Cy1 (1Cy=21 days): Predose (Hr0), 0.5,24,72 hrs postinfusion (infusion duration=1.5 hrs) on D1; on D8, 15; Cy2-7: Hr0, 0.5 hrs postinfusion on D1; Cy8,12,16, then every 8 Cy up to TDV (approx. 3 years): Hr0 on D1; every 30 days after TDV up to 120 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Serum Concentration (Cmax) of MOXR0916</measure>
    <time_frame>Cy1 (1Cy=21 days): Predose (Hr0), 0.5,24,72 hrs postinfusion (infusion duration=1.5 hrs) on D1; on D8, 15; Cy2-7: Hr0, 0.5 hrs postinfusion on D1; Cy8,12,16, then every 8 Cy up to TDV (approx. 3 years): Hr0 on D1; every 30 days after TDV up to 120 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Observed Serum Concentration (Cmin) of MOXR0916</measure>
    <time_frame>Cy1 (1Cy=21 days): Predose (Hr0), 0.5,24,72 hrs postinfusion (infusion duration=1.5 hrs) on D1; on D8, 15; Cy2-7: Hr0, 0.5 hrs postinfusion on D1; Cy8,12,16, then every 8 Cy up to TDV (approx. 3 years): Hr0 on D1; every 30 days after TDV up to 120 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Clearance (CL/F) of MOXR0916</measure>
    <time_frame>Cy1 (1Cy=21 days): Predose (Hr0), 0.5,24,72 hrs postinfusion (infusion duration=1.5 hrs) on D1; on D8, 15; Cy2-7: Hr0, 0.5 hrs postinfusion on D1; Cy8,12,16, then every 8 Cy up to TDV (approx. 3 years): Hr0 on D1; every 30 days after TDV up to 120 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Volume of Distribution at Steady State (Vss) of MOXR0916</measure>
    <time_frame>Cy1 (1Cy=21 days): Predose (Hr0), 0.5,24,72 hrs postinfusion (infusion duration=1.5 hrs) on D1; on D8, 15; Cy2-7: Hr0, 0.5 hrs postinfusion on D1; Cy8,12,16, then every 8 Cy up to TDV (approx. 3 years): Hr0 on D1; every 30 days after TDV up to 120 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Objective Response as Determined Using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)</measure>
    <time_frame>Baseline, end of Cycles 2, 4, 6, 8, and every 4 cycles thereafter (cycle length=21 days) until disease progression, death, another anti-cancer therapy initiation, loss to follow-up, consent withdrawal, or study termination (approximately up to 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Objective Response (DOR) as Determined Using RECIST v1.1</measure>
    <time_frame>Baseline, end of Cycles 2, 4, 6, 8, and every 4 cycles thereafter (cycle length=21 days) until disease progression, death, another anti-cancer therapy initiation, loss to follow-up, consent withdrawal, or study termination (approximately up to 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS) as Determined Using RECIST v1.1</measure>
    <time_frame>Baseline, end of Cycles 2, 4, 6, 8, and every 4 cycles thereafter (cycle length=21 days) until disease progression, death, another anti-cancer therapy initiation, loss to follow-up, consent withdrawal, or study termination (approximately up to 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Objective Response as Determined Using Modified RECIST</measure>
    <time_frame>Baseline, end of Cycles 2, 4, 6, 8, and every 4 cycles thereafter (cycle length=21 days) until disease progression, death, another anti-cancer therapy initiation, loss to follow-up, consent withdrawal, or study termination (approximately up to 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DOR as Determined Using Modified RECIST</measure>
    <time_frame>Baseline, end of Cycles 2, 4, 6, 8, and every 4 cycles thereafter (cycle length=21 days) until disease progression, death, another anti-cancer therapy initiation, loss to follow-up, consent withdrawal, or study termination (approximately up to 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS as Determined Using Modified RECIST</measure>
    <time_frame>Baseline, end of Cycles 2, 4, 6, 8, and every 4 cycles thereafter (cycle length=21 days) until disease progression, death, another anti-cancer therapy initiation, loss to follow-up, consent withdrawal, or study termination (approximately up to 3 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Baseline until death, loss to follow-up, withdrawal of consent, or study termination by the Sponsor (approximately up to 3 years)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">174</enrollment>
  <condition>Neoplasms</condition>
  <arm_group>
    <arm_group_label>MOXR0916: Dose Escalation Stage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in different cohorts (according to MOXR0916 dose received) will receive escalating doses of MOXR0916 to determine the MTD or maximum administered dose (MAD) for 21 to 42 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MOXR0916: Expansion Stage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in different cohorts (according to different cancer types, prior therapy and mandatory procedures on study) will receive MOXR0916 at the highest dose level that has already been deemed to be tolerable in the dose escalation stage until disease progression, loss of clinical benefit or unacceptable toxicity, whichever occurred first (approximately up to 3 years).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MOXR0916</intervention_name>
    <description>MOXR0916 will be administered as intravenous infusion on Day 1 of each 21-day cycle.</description>
    <arm_group_label>MOXR0916: Dose Escalation Stage</arm_group_label>
    <arm_group_label>MOXR0916: Expansion Stage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologic documentation of locally advanced, recurrent or metastatic incurable solid&#xD;
             malignancy that has progressed after all available standard therapy or for which&#xD;
             standard therapy has proven to be ineffective or intolerable, or is considered&#xD;
             inappropriate&#xD;
&#xD;
          -  Confirmed availability of representative tumor specimens in paraffin blocks/unstained&#xD;
             slides&#xD;
&#xD;
          -  Measurable disease per RECIST v1.1&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
&#xD;
          -  Adequate hematologic and end organ function&#xD;
&#xD;
          -  For female participants of childbearing potential, agreement to use highly effective&#xD;
             form(s) of contraception and to continue its use for 6 months after the last dose of&#xD;
             MOXR0916&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any anti-cancer therapy, including chemotherapy, hormonal therapy, or radiotherapy,&#xD;
             within 3 weeks prior to initiation of study treatment (hormonal therapy with&#xD;
             gonadotropin-releasing hormone agonists or antagonists for prostate cancer and&#xD;
             palliative radiotherapy greater than (&gt;) 2 weeks prior to Cycle 1, Day 1 are allowed)&#xD;
&#xD;
          -  Eligibility based on prior treatment with immunomodulatory agents depends on the&#xD;
             mechanistic class of the drug and the cohort for which the participant is being&#xD;
             considered&#xD;
&#xD;
          -  Adverse events from prior anti-cancer therapy that have not resolved to Grade less&#xD;
             than or equal to (&lt;/=) 1 except for alopecia or endocrinopathy managed with&#xD;
             replacement therapy&#xD;
&#xD;
          -  Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases&#xD;
&#xD;
          -  Leptomeningeal disease&#xD;
&#xD;
          -  Malignancies other than disease under study within 5 years&#xD;
&#xD;
          -  History of autoimmune disease&#xD;
&#xD;
          -  History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced),&#xD;
             organizing pneumonia, or evidence of active pneumonitis on screening chest computed&#xD;
             tomography (CT) scan; history of radiation pneumonitis in the radiation field&#xD;
             (fibrosis) is permitted&#xD;
&#xD;
          -  Positive test for human immunodeficiency virus infection&#xD;
&#xD;
          -  Active hepatitis B or active hepatitis C&#xD;
&#xD;
          -  Severe infections within 4 weeks or signs or symptoms of infection within 2 weeks&#xD;
             prior to Cycle 1&#xD;
&#xD;
          -  Prior allogeneic bone marrow transplantation or prior solid organ transplantation&#xD;
&#xD;
          -  Significant cardiovascular disease&#xD;
&#xD;
          -  Known clinically significant 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>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HonorHealth Research Institute - Bisgrove</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045-2517</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgetown University Medical Center Lombardi Cancer Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of Chicago Medical Center; Section Of Hematology/Oncology</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Can Ins</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</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>Sarah Cannon Research Institute</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chris O'Brien Lifehouse</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Hospital</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</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>Sir Charles Gairdner Hospital</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jules Bordet</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sint Augustinus Wilrijk</name>
      <address>
        <city>Wilrijk</city>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Health Sciences - Juravinski Cancer Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital Cancer Centre; Oncology</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network; Princess Margaret Hospital; Medical Oncology Dept</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center - Oncology</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yonsei University Health System/Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universitaria de Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp de Madrid Norte Sanchinarro; Centro Integral; Onco Clara Campal</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Korea, Republic of</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>February 3, 2020</last_update_submitted>
  <last_update_submitted_qc>February 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02219724
org study id: GO29313
secondary id: 2014-001474-34
nct id: NCT02219724
lead sponsor: 
This is a first-in-human, Phase 1, open-label, multicenter, dose-escalation study designed to
      evaluate the safety, tolerability, and pharmacokinetics of MOXR0916 administered
      intravenously in participants with locally advanced or metastatic solid tumors that have
      progressed after all available standard therapy or for which standard therapy has proven to
      be ineffective or intolerable, or is considered inappropriate. This study will consist of a
      screening period, an initial treatment period, a re-treatment period (for participants who
      discontinue MOXR0916 after demonstration of prolonged clinical benefit), and a post-treatment
      follow-up period. Participants will be enrolled in two stages: a dose-escalation stage and an
      expansion stage. The planned duration of the study is approximately 3 years.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Dose Limiting Toxicities (DLTs)
time frame: Day 1 Up to Day 21 or 42
measure: Percentage of Participants With Adverse Events (AEs) by Severity as Graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0)
time frame: Baseline up to 90 days after the last dose of study treatment, or until the initiation of another systemic anti-cancer therapy, whichever occurs first (approximately up to 3 years)
measure: Maximum Tolerated Dose (MTD) of MOXR0916
time frame: Baseline up to 21 to 42 days
measure: Recommended Phase II Dose of MOXR0916
time frame: Baseline up to 21 to 42 days
measure: Percentage of Participants With Anti-MOXR0916 Antibodies
time frame: Pre-dose (Hour [Hr] 0) on Day (D) 1 of Cycles (Cy) 1,2,3,4,8,12,16, & then every 8 Cy up to treatment discontinuation visit (TDV) (up to approximately 3 years) (1 Cy=21 days), thereafter every 30 days for up to 120 days after treatment discontinuation
measure: Number of Cycles of MOXR0916 Treatment Received
time frame: Baseline up to approximately 3 years
measure: Mean MOXR0916 Dose Administered During Study
time frame: Baseline up to approximately 3 years
measure: Area Under the Serum Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of MOXR0916
time frame: Cy1 (1Cy=21 days): Predose (Hr0), 0.5,24,72 hrs postinfusion (infusion duration=1.5 hrs) on D1; on D8, 15; Cy2-7: Hr0, 0.5 hrs postinfusion on D1; Cy8,12,16, then every 8 Cy up to TDV (approx. 3 years): Hr0 on D1; every 30 days after TDV up to 120 days
measure: Maximum Observed Serum Concentration (Cmax) of MOXR0916
time frame: Cy1 (1Cy=21 days): Predose (Hr0), 0.5,24,72 hrs postinfusion (infusion duration=1.5 hrs) on D1; on D8, 15; Cy2-7: Hr0, 0.5 hrs postinfusion on D1; Cy8,12,16, then every 8 Cy up to TDV (approx. 3 years): Hr0 on D1; every 30 days after TDV up to 120 days
measure: Minimum Observed Serum Concentration (Cmin) of MOXR0916
time frame: Cy1 (1Cy=21 days): Predose (Hr0), 0.5,24,72 hrs postinfusion (infusion duration=1.5 hrs) on D1; on D8, 15; Cy2-7: Hr0, 0.5 hrs postinfusion on D1; Cy8,12,16, then every 8 Cy up to TDV (approx. 3 years): Hr0 on D1; every 30 days after TDV up to 120 days
measure: Serum Clearance (CL/F) of MOXR0916
time frame: Cy1 (1Cy=21 days): Predose (Hr0), 0.5,24,72 hrs postinfusion (infusion duration=1.5 hrs) on D1; on D8, 15; Cy2-7: Hr0, 0.5 hrs postinfusion on D1; Cy8,12,16, then every 8 Cy up to TDV (approx. 3 years): Hr0 on D1; every 30 days after TDV up to 120 days
measure: Apparent Volume of Distribution at Steady State (Vss) of MOXR0916
time frame: Cy1 (1Cy=21 days): Predose (Hr0), 0.5,24,72 hrs postinfusion (infusion duration=1.5 hrs) on D1; on D8, 15; Cy2-7: Hr0, 0.5 hrs postinfusion on D1; Cy8,12,16, then every 8 Cy up to TDV (approx. 3 years): Hr0 on D1; every 30 days after TDV up to 120 days
measure: Percentage of Participants With Objective Response as Determined Using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
time frame: Baseline, end of Cycles 2, 4, 6, 8, and every 4 cycles thereafter (cycle length=21 days) until disease progression, death, another anti-cancer therapy initiation, loss to follow-up, consent withdrawal, or study termination (approximately up to 3 years)
measure: Duration of Objective Response (DOR) as Determined Using RECIST v1.1
time frame: Baseline, end of Cycles 2, 4, 6, 8, and every 4 cycles thereafter (cycle length=21 days) until disease progression, death, another anti-cancer therapy initiation, loss to follow-up, consent withdrawal, or study termination (approximately up to 3 years)
measure: Progression-free Survival (PFS) as Determined Using RECIST v1.1
time frame: Baseline, end of Cycles 2, 4, 6, 8, and every 4 cycles thereafter (cycle length=21 days) until disease progression, death, another anti-cancer therapy initiation, loss to follow-up, consent withdrawal, or study termination (approximately up to 3 years)
measure: Percentage of Participants With Objective Response as Determined Using Modified RECIST
time frame: Baseline, end of Cycles 2, 4, 6, 8, and every 4 cycles thereafter (cycle length=21 days) until disease progression, death, another anti-cancer therapy initiation, loss to follow-up, consent withdrawal, or study termination (approximately up to 3 years)
measure: DOR as Determined Using Modified RECIST
time frame: Baseline, end of Cycles 2, 4, 6, 8, and every 4 cycles thereafter (cycle length=21 days) until disease progression, death, another anti-cancer therapy initiation, loss to follow-up, consent withdrawal, or study termination (approximately up to 3 years)
measure: PFS as Determined Using Modified RECIST
time frame: Baseline, end of Cycles 2, 4, 6, 8, and every 4 cycles thereafter (cycle length=21 days) until disease progression, death, another anti-cancer therapy initiation, loss to follow-up, consent withdrawal, or study termination (approximately up to 3 years)
measure: Overall Survival (OS)
time frame: Baseline until death, loss to follow-up, withdrawal of consent, or study termination by the Sponsor (approximately up to 3 years)
arm group label: MOXR0916: Dose Escalation Stage
arm group type: Experimental
description: Participants in different cohorts (according to MOXR0916 dose received) will receive escalating doses of MOXR0916 to determine the MTD or maximum administered dose (MAD) for 21 to 42 days.
arm group label: MOXR0916: Expansion Stage
arm group type: Experimental
description: Participants in different cohorts (according to different cancer types, prior therapy and mandatory procedures on study) will receive MOXR0916 at the highest dose level that has already been deemed to be tolerable in the dose escalation stage until disease progression, loss of clinical benefit or unacceptable toxicity, whichever occurred first (approximately up to 3 years).
intervention type: Drug
intervention name: MOXR0916
description: MOXR0916 will be administered as intravenous infusion on Day 1 of each 21-day cycle.
arm group label: MOXR0916: Dose Escalation Stage
arm group label: MOXR0916: Expansion Stage
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
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country: Australia
country: Belgium
country: Canada
country: Korea, Republic of
country: Spain
country: United States
responsible party type: Sponsor