<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/NCT04423029</url>
  </required_header>
  <id_info>
    <org_study_id>CA101-001</org_study_id>
    <secondary_id>2021-000038-33</secondary_id>
    <nct_id>NCT04423029</nct_id>
  </id_info>
  <brief_title>A Study of DF6002 Alone and in Combination With Nivolumab</brief_title>
  <official_title>A Phase 1/2, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dragonfly Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dragonfly Therapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety, tolerability, drug-levels, drug-effects&#xD;
      and preliminary anti-tumor activity of DF6002 alone and in combination with Nivolumab in&#xD;
      participants with advanced solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 13, 2020</start_date>
  <completion_date type="Anticipated">December 16, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 19, 2024</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Number of participants with dose-limiting toxicities (DLTs)</measure>
    <time_frame>During the first 3 weeks of treatment</time_frame>
    <description>Phase 1/1b only</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per an Independent Endpoint Review Committee (IERC)</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Phase 2 only</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment emergent adverse events (TEAEs)</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of TEAEs</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of TEAEs</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with changes from baseline in clinical laboratory parameters</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with changes from baseline in electrocardiogram (ECG) parameters</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with changes from baseline in vital sign parameters</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with changes from baseline in Eastern Cooperative Oncology Group (ECOG) performance status</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) according to RECIST 1.1 per Investigator assessment</measure>
    <time_frame>Up to month 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from the time of dosing to the time of the last observation (AUC 0-T)</measure>
    <time_frame>Up to day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from the time of dosing extrapolated to infinity (AUC 0-INF)</measure>
    <time_frame>Up to day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum serum concentration observed post-dose (Cmax)</measure>
    <time_frame>Up to day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best overall response (BOR) according to RECIST 1.1 per Investigator assessment</measure>
    <time_frame>Approximately one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical benefit rate (CBR) according to RECIST 1.1 per Investigator assessment</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Confirmed ORR per RECIST 1.1 per Investigator assessment</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Phase 1/1b only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS) according to RECIST 1.1 per Investigator assessment</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Phase 2 only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CBR according to RECIST 1.1 per IERC</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Phase 2 only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS according to RECIST 1.1 per IERC</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Phase 2 only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DOR according to RECIST 1.1 per IERC</measure>
    <time_frame>Up to month 24</time_frame>
    <description>Phase 2 only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unconfirmed response after 4 cycles according to RECIST 1.1</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Phase 2 only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Phase 2 only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum titers of anti-DF6002 antibodies</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Phase 2 only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum titers of anti-nivolumab antibodies</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Phase 2 only</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">473</enrollment>
  <condition>Solid Tumors</condition>
  <arm_group>
    <arm_group_label>Monotherapy Dose Escalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Monotherapy Dose Expansion (Melanoma)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Monotherapy Dose Expansion (NSCLC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Combination Dose Escalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Combination Dose Expansion (Melanoma)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Combination Dose Expansion (NSCLC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DF6002</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Combination Dose Escalation</arm_group_label>
    <arm_group_label>Combination Dose Expansion (Melanoma)</arm_group_label>
    <arm_group_label>Combination Dose Expansion (NSCLC)</arm_group_label>
    <arm_group_label>Monotherapy Dose Escalation</arm_group_label>
    <arm_group_label>Monotherapy Dose Expansion (Melanoma)</arm_group_label>
    <arm_group_label>Monotherapy Dose Expansion (NSCLC)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Combination Dose Escalation</arm_group_label>
    <arm_group_label>Combination Dose Expansion (Melanoma)</arm_group_label>
    <arm_group_label>Combination Dose Expansion (NSCLC)</arm_group_label>
    <other_name>Opdivo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Advanced/metastatic solid tumors, for which no standard therapy exists or standard&#xD;
             therapy has failed among the following tumor types: melanoma, non-small cell lung&#xD;
             cancer, small cell lung cancer, head and neck squamous cell, urothelial, gastric,&#xD;
             esophageal, cervical, hepatocellular, merkel cell, cutaneous squamous cell carcinoma,&#xD;
             renal cell, endometrial, triple-negative breast, ovarian, and prostate&#xD;
&#xD;
          -  ECOG performance status of 0 or 1&#xD;
&#xD;
          -  Clinical or radiological evidence of disease&#xD;
&#xD;
          -  Adequate hematological, hepatic and renal function&#xD;
&#xD;
          -  Anticoagulants are required for the following: Khorana Risk Score ≥ 2 or as assessed&#xD;
             by Investigator as being at high risk for venous thromboembolism (VTE) or history of&#xD;
             VTE ≥ 6 months from enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent anticancer treatment (with the exception of palliative bone directed&#xD;
             radiotherapy), immune therapy, or cytokine therapy (except for erythropoietin), major&#xD;
             surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids&#xD;
             or other immunosuppressive agents, or use of any investigational drug within 28 days&#xD;
             before the start of study treatment&#xD;
&#xD;
          -  Previous malignant disease other than the current target malignancy within the last 3&#xD;
             years, with the exception of basal or squamous cell carcinoma of the skin, localized&#xD;
             prostate cancer or cervical carcinoma in situ&#xD;
&#xD;
          -  Rapidly progressive disease&#xD;
&#xD;
          -  Serious cardiac illness or medical conditions&#xD;
&#xD;
          -  Known diagnosis of antiphospholipid syndrome or clinically significant hereditary&#xD;
             thrombophilia&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria 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>Jean-Marie Cuillerot, MD</last_name>
    <role>Study Director</role>
    <affiliation>Chief Medical Officer</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sean Rossi</last_name>
    <phone>617-588-0086</phone>
    <email>sean.rossi@dragonflytx.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of California Irvine</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Valerin, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>SCRI - HealthOne Denver</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Local Institution</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>Yale School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mario Sznol, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jose Lutzky, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Augusta University Georgia Cancer Center</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912-0003</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sharad Ghamande, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohammed Milhem, MD</last_name>
    </contact>
  </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>
    <contact>
      <last_name>Elizabeth Buchbinder, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Barbara Ann Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dipesh Uprety, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raghad Abdul-Karim, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>HealthPartners Cancer Center at Regions Hospital</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55101</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arkadiusz Dudek, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55101</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Atlantic Health System</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric Whitman, Site 0004</last_name>
      <phone>973-971-7111</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jinyu Lu, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Roswell Park Comprehensive Cancer Center</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christos Fountzilas, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jorge Garcia, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution</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>Stephenson Cancer Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raid Aljumaily, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benedito Carneiro, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>SCRI - Tennessee Oncology - Saint Thomas West Clinic</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Meredith McKean, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hussein Tawbi, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sangeeta Goswami, Site 0009</last_name>
      <phone>832-292-4157</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute and Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Siwen Hu-Lieskovan, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>USOR - Virginia Cancer Specialists - Fairfax Office</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexander Spira, Site 0015</last_name>
      <phone>703-280-5390</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Froedtert Hospital</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ariel Nelson, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0023</name>
      <address>
        <city>Box Hill</city>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0022</name>
      <address>
        <city>Heidelberg</city>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Pierre-Bénite</city>
        <state>Rhone</state>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0026</name>
      <address>
        <city>Bordeaux Cedex</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site 0026</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0002</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site 0002</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0027</name>
      <address>
        <city>Pierre-Benite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site 0027</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0001</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site 0001</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Pamplona</city>
        <state>Navarre</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0029</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site 0029</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Madrid</city>
        <zip>08040</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0031</name>
      <address>
        <city>Madrid</city>
        <zip>28027</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site 0031</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0030</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site 0030</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0028</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site 0028</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0025</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site 0025</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>France</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>April 19, 2023</last_update_submitted>
  <last_update_submitted_qc>April 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Advanced or Metastatic Solid Tumors</keyword>
  <keyword>Melanoma</keyword>
  <keyword>Non-small Cell Lung Cancer</keyword>
  <keyword>Nivolumab</keyword>
  <keyword>DF6002 (BMS-986415)</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nivolumab</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04423029
org study id: CA101-001
secondary id: 2021-000038-33
nct id: NCT04423029
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the safety, tolerability, drug-levels, drug-effects
      and preliminary anti-tumor activity of DF6002 alone and in combination with Nivolumab in
      participants with advanced solid tumors.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with dose-limiting toxicities (DLTs)
time frame: During the first 3 weeks of treatment
description: Phase 1/1b only
measure: Overall Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per an Independent Endpoint Review Committee (IERC)
time frame: Up to 2 years
description: Phase 2 only
measure: Number of participants with treatment emergent adverse events (TEAEs)
time frame: Up to 2 years
measure: Severity of TEAEs
time frame: Up to 2 years
measure: Duration of TEAEs
time frame: Up to 2 years
measure: Number of participants with changes from baseline in clinical laboratory parameters
time frame: Up to 2 years
measure: Number of participants with changes from baseline in electrocardiogram (ECG) parameters
time frame: Up to 2 years
measure: Number of participants with changes from baseline in vital sign parameters
time frame: Up to 2 years
measure: Number of participants with changes from baseline in Eastern Cooperative Oncology Group (ECOG) performance status
time frame: Up to 2 years
measure: Duration of Response (DOR) according to RECIST 1.1 per Investigator assessment
time frame: Up to month 24
measure: Area under the plasma concentration-time curve from the time of dosing to the time of the last observation (AUC 0-T)
time frame: Up to day 28
measure: Area under the plasma concentration-time curve from the time of dosing extrapolated to infinity (AUC 0-INF)
time frame: Up to day 28
measure: Maximum serum concentration observed post-dose (Cmax)
time frame: Up to day 28
measure: Best overall response (BOR) according to RECIST 1.1 per Investigator assessment
time frame: Approximately one year
measure: Clinical benefit rate (CBR) according to RECIST 1.1 per Investigator assessment
time frame: Up to 2 years
measure: Confirmed ORR per RECIST 1.1 per Investigator assessment
time frame: Up to 2 years
description: Phase 1/1b only
measure: Progression-free survival (PFS) according to RECIST 1.1 per Investigator assessment
time frame: Up to 2 years
description: Phase 2 only
measure: CBR according to RECIST 1.1 per IERC
time frame: Up to 2 years
description: Phase 2 only
measure: PFS according to RECIST 1.1 per IERC
time frame: Up to 2 years
description: Phase 2 only
measure: DOR according to RECIST 1.1 per IERC
time frame: Up to month 24
description: Phase 2 only
measure: Unconfirmed response after 4 cycles according to RECIST 1.1
time frame: Up to 2 years
description: Phase 2 only
measure: Overall Survival (OS)
time frame: Up to 5 years
description: Phase 2 only
measure: Serum titers of anti-DF6002 antibodies
time frame: Up to 2 years
description: Phase 2 only
measure: Serum titers of anti-nivolumab antibodies
time frame: Up to 2 years
description: Phase 2 only
arm group label: Monotherapy Dose Escalation
arm group type: Experimental
arm group label: Monotherapy Dose Expansion (Melanoma)
arm group type: Experimental
arm group label: Monotherapy Dose Expansion (NSCLC)
arm group type: Experimental
arm group label: Combination Dose Escalation
arm group type: Experimental
arm group label: Combination Dose Expansion (Melanoma)
arm group type: Experimental
arm group label: Combination Dose Expansion (NSCLC)
arm group type: Experimental
intervention type: Drug
intervention name: DF6002
description: Specified dose on specified days
arm group label: Combination Dose Escalation
arm group label: Combination Dose Expansion (Melanoma)
arm group label: Combination Dose Expansion (NSCLC)
arm group label: Monotherapy Dose Escalation
arm group label: Monotherapy Dose Expansion (Melanoma)
arm group label: Monotherapy Dose Expansion (NSCLC)
intervention type: Drug
intervention name: Nivolumab
description: Specified dose on specified days
arm group label: Combination Dose Escalation
arm group label: Combination Dose Expansion (Melanoma)
arm group label: Combination Dose Expansion (NSCLC)
other name: Opdivo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Marie Cuillerot, MD
role: Study Director
affiliation: Chief Medical Officer
last name: Sean Rossi
phone: 617-588-0086
email: sean.rossi@dragonflytx.com
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Australia
country: France
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Nivolumab