<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/NCT03829501</url>
  </required_header>
  <id_info>
    <org_study_id>KY1044-CT01</org_study_id>
    <secondary_id>Sanofi Study ID</secondary_id>
    <nct_id>NCT03829501</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of KY1044 and Atezolizumab in Advanced Cancer</brief_title>
  <official_title>A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of KY1044 as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kymab Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Kymab Limited</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A Phase 1/2, open label, multi-center study to evaluate the safety, efficacy and tolerability&#xD;
      of KY1044 as single agent and in combination with anti-PD-L1 (atezolizumab) in adult patients&#xD;
      with selected advanced malignancies, who are ineligible for or there are no available&#xD;
      therapies known to confer a clinical benefit for their disease, or they have exhausted all&#xD;
      such available options in each indication and therefore will be patients for whom a clinical&#xD;
      trial is appropriate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 28, 2019</start_date>
  <completion_date type="Anticipated">November 2024</completion_date>
  <primary_completion_date type="Anticipated">November 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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1)</measure>
    <time_frame>Up to 48 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Tolerability: Number of dose interruptions, reductions and dose intensity (Phase 1)</measure>
    <time_frame>Up to 48 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Phase 2)</measure>
    <time_frame>Up to 48 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Dose Limiting Toxicities (DLTs) with KY1044 as single agent (Phase 1)</measure>
    <time_frame>Within first 21 days of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of DLTs with KY1044 in combination with atezolizumab (Phase 1)</measure>
    <time_frame>Within first 21 days of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best overall response (BOR) per RECIST 1.1</measure>
    <time_frame>Up to 48 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS) per RECIST 1.1</measure>
    <time_frame>Up to a PFS event, approximately every 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) per RECIST 1.1</measure>
    <time_frame>Up to a PFS event, approximately every 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR per Immune-Related Response Evaluation Criteria in Solid Tumors (iRECIST) (Phase 1 and Phase 2)</measure>
    <time_frame>Up to 48 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS per iRECIST (Phase 1 and Phase 2)</measure>
    <time_frame>Up to 48 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR per RECIST 1.1 (Phase 1)</measure>
    <time_frame>Up to 48 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival rate</measure>
    <time_frame>At 12 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Incidence and severity of AEs and SAEs (Phase 2)</measure>
    <time_frame>Up to 48 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of dose interruptions, reductions and dose intensity (Phase 2)</measure>
    <time_frame>Up to 48 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Concentration (Cmax) of KY1044 and of atezolizumab if in combination</measure>
    <time_frame>Up to 48 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half-life (t1/2) of of KY1044 and of atezolizumab if in combination</measure>
    <time_frame>Up to 48 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with anti-KY1044 and anti-atezolizumab antibodies</measure>
    <time_frame>Up to 48 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with presence of tumor-infiltrating lymphocytes (TILs) as determined by expression of ICOS (Inducible T cell Costimulator), FOXP3 (Forkhead box P3) and CD8 cells</measure>
    <time_frame>Up to 48 months</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">280</enrollment>
  <condition>Squamous Cell Carcinoma of Head and Neck</condition>
  <condition>Non-small Cell Lung Cancer</condition>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>Esophageal Cancer</condition>
  <condition>Gastric Cancer</condition>
  <condition>Melanoma</condition>
  <condition>Renal Cell Carcinoma</condition>
  <condition>Pancreatic Cancer</condition>
  <condition>Cervical Cancer</condition>
  <condition>Triple Negative Breast Cancer</condition>
  <condition>Advanced Cancer</condition>
  <condition>Metastatic Cancer</condition>
  <arm_group>
    <arm_group_label>KY1044 monotherapy phase 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>KY1044 monotherapy dose escalation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KY1044 and atezolizumab phase 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>KY1044 and atezolizumab combination dose escalation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KY1044 monotherapy phase 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>KY1044 monotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KY1044 and atezolizumab phase 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>KY1044 and atezolizumab combination</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KY1044</intervention_name>
    <description>A human anti-ICOS monoclonal antibody</description>
    <arm_group_label>KY1044 monotherapy phase 1</arm_group_label>
    <arm_group_label>KY1044 monotherapy phase 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KY1044 and atezolizumab</intervention_name>
    <description>A human anti-ICOS monoclonal antibody in combination with anti-PD-L1 monoclonal antibody (atezolizumab)</description>
    <arm_group_label>KY1044 and atezolizumab phase 1</arm_group_label>
    <arm_group_label>KY1044 and atezolizumab phase 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years (≥20 years in Taiwan)&#xD;
&#xD;
          -  Histologically documented advanced/metastatic malignancies&#xD;
&#xD;
          -  Phase 1 and Phase 2 participants with advanced/metastatic malignancies who have&#xD;
             measurable disease (non-measurable disease is allowed only in Phase 1) as determined&#xD;
             by RECIST 1.1 will be eligible if, according to the National Comprehensive Cancer&#xD;
             Network (NCCN) guidelines, there are no available therapies known to confer a clinical&#xD;
             benefit for their disease, or they have exhausted all such available options.&#xD;
             Additionally, the following specific tumor indications will be enrolled:&#xD;
&#xD;
               1. Phase 1: Participants with advanced/metastatic malignancies, and preferred&#xD;
                  indications (non-small cell lung cancer (NSCLC), head and neck squamous cell&#xD;
                  carcinoma (HNSCC), hepatocellular carcinoma (HCC), melanoma, cervical,&#xD;
                  esophageal, gastric, renal, pancreatic, and triple negative breast cancer)&#xD;
&#xD;
               2. Phase 2 KY1044 single agent: Participants with advanced/metastatic malignancies&#xD;
                  in indications in which signs of anti-tumor activity (Complete Response (CR),&#xD;
                  Partial Response (PR) or durable stable disease (SD) with tumor shrinkage that&#xD;
                  does not qualify for PR) were seen during the dose escalation of KY1044 as single&#xD;
                  agent&#xD;
&#xD;
               3. Phase 2 KY1044 in combination with atezolizumab: Participants with&#xD;
                  advanced/metastatic malignancies in the selected indications below, and/or&#xD;
                  indications which have shown promising activity in Phase 1:&#xD;
&#xD;
                    -  NSCLC (anti-PD-(L)1 therapy naïve and pre-treated between 1 and 2 prior&#xD;
                       lines of systemic therapy for advanced disease)&#xD;
&#xD;
                    -  Gastric (anti-PD-(L)1 therapy naïve and pre-treated)&#xD;
&#xD;
                    -  Recurrent and/or metastatic HNSCC (anti-PD-(L)1 therapy naïve and&#xD;
                       pre-treated between 1 and 2 prior lines of systemic therapy for advanced&#xD;
                       disease)&#xD;
&#xD;
                    -  Esophageal (anti-PD-(L)1 therapy naïve and pre-treated)&#xD;
&#xD;
                    -  Cervical (anti-PD-(L)1 therapy naïve and pre-treated)&#xD;
&#xD;
                    -  Indications, in which signs of anti-tumor activity has been observed in&#xD;
                       Phase 1 with KY1044 in combination with atezolizumab&#xD;
&#xD;
          -  Prior therapy with anti-PD-(L)1 inhibitors is allowed provided any toxicity attributed&#xD;
             to prior anti-PD-(L)1-directed therapy did not lead to discontinuation of therapy&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1&#xD;
&#xD;
          -  Life expectancy longer than 12 weeks&#xD;
&#xD;
          -  Must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy&#xD;
             according to the treating institution's guidelines. Participants must be willing to&#xD;
             undergo a new tumor biopsy at screening, and during therapy on the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases&#xD;
             that require local CNS-directed therapy, or increasing doses of corticosteroids within&#xD;
             the prior 2 weeks of first dose of study treatment&#xD;
&#xD;
          -  History of severe hypersensitivity reactions to other monoclonal antibodies and/or&#xD;
             their excipients&#xD;
&#xD;
          -  Known presence of neutralizing anti-atezolizumab antibodies (for patients previously&#xD;
             treated with atezolizumab)&#xD;
&#xD;
          -  Having out of range laboratory values: creatinine, bilirubin, alanine aminotransferase&#xD;
             (ALT), aspartate aminotransferase (AST), absolute neutrophil count (ANC), platelet&#xD;
             count, hemoglobin&#xD;
&#xD;
          -  Impaired cardiac function or clinically significant cardiac disease, including any of&#xD;
             the following:&#xD;
&#xD;
               1. Clinically significant and/or uncontrolled heart disease such as congestive heart&#xD;
                  failure requiring treatment (New York Heart Association [NYHA] Grade ≥2),&#xD;
                  uncontrolled hypertension or clinically significant arrhythmia&#xD;
&#xD;
               2. QTcF &gt;470 msec on screening (electrocardiogram) ECG using Fridericia's formula&#xD;
                  (QTcF) or congenital long QT syndrome&#xD;
&#xD;
               3. Acute myocardial infarction or unstable angina pectoris&#xD;
&#xD;
          -  Known human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or active&#xD;
             hepatitis C virus (HCV) infection&#xD;
&#xD;
          -  Malignant disease, other than that being treated in this study&#xD;
&#xD;
          -  Any medical condition that would, in the Investigator's judgment, prevent&#xD;
             participation in the clinical study due to safety concerns, compliance with clinical&#xD;
             study procedures or interpretation of study results&#xD;
&#xD;
          -  Active autoimmune disease or a documented history of autoimmune disease&#xD;
&#xD;
          -  Participants previously exposed to anti-PD-(L)1 treatment who are not adequately&#xD;
             treated for skin rash or had no replacement therapy for endocrinopathies should be&#xD;
             excluded&#xD;
&#xD;
          -  Participants with a history of drug-induced pneumonitis or current pneumonitis&#xD;
&#xD;
          -  Systemic steroid therapy or any immunosuppressive therapy. Topical, inhaled, nasal,&#xD;
             and ophthalmic steroids are not prohibited&#xD;
&#xD;
          -  Use of live attenuated vaccines against infectious diseases within 4 weeks of the&#xD;
             first dose of study treatment. SARS-CoV-2 vaccines authorized for use by the competent&#xD;
             local regulatory health authorities for active immunization to prevent COVID 19 are&#xD;
             allowed (unless the vaccine is live or live attenuated) and must be given in&#xD;
             accordance with the prevailing immunization guidelines.&#xD;
&#xD;
          -  Anti-CTLA4, anti-PD-(L)1 treatment within 4 weeks of the first dose of study treatment&#xD;
&#xD;
          -  Pre-treatment with anti-CTLA4 antibodies in combination with any other antibody or&#xD;
             drug specifically targeting T-cell co-stimulation or checkpoint pathway&#xD;
&#xD;
          -  Presence of Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) ≥Grade&#xD;
             2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded&#xD;
             if CTCAE v5 ≥Grade 3) due to prior cancer therapy&#xD;
&#xD;
          -  Radiotherapy within 2 weeks of the first dose of study treatment, except for&#xD;
             palliative radiotherapy to a limited field, such as for the treatment of bone pain or&#xD;
             a focally painful tumor mass. To allow evaluation for response to treatment,&#xD;
             participants enrolled in the Phase 2 part must have remaining measurable disease that&#xD;
             has not been irradiated&#xD;
&#xD;
          -  Pregnant or lactating women&#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 Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kymab investigational site 1109</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 1102</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 1108</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 1104</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 1103</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigator site 1101</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 3601</name>
      <address>
        <city>Nyíregyháza</city>
        <state>Szabolcs-Szatmár-Bereg</state>
        <zip>4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 3602</name>
      <address>
        <city>Budapest</city>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 3904</name>
      <address>
        <city>Meldola</city>
        <state>Forlì-Cesena</state>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 3906</name>
      <address>
        <city>Candiolo</city>
        <state>Torino</state>
        <zip>10060</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 3901</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 3903</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 3902</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 3910</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 3908</name>
      <address>
        <city>Turin</city>
        <zip>10128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 4801</name>
      <address>
        <city>Siedlce</city>
        <state>Mazowieckie</state>
        <zip>04-141</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 8806</name>
      <address>
        <city>Changhua City</city>
        <state>Changhwa</state>
        <zip>505</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 8801</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 4405</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 4402</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 4404</name>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kymab investigational site 4401</name>
      <address>
        <city>Sutton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>August 17, 2023</last_update_submitted>
  <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
    <mesh_term>Triple Negative Breast Neoplasms</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atezolizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at https://vivli.org</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/NCT03829501
org study id: KY1044-CT01
secondary id: Sanofi Study ID
nct id: NCT03829501
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
A Phase 1/2, open label, multi-center study to evaluate the safety, efficacy and tolerability
      of KY1044 as single agent and in combination with anti-PD-L1 (atezolizumab) in adult patients
      with selected advanced malignancies, who are ineligible for or there are no available
      therapies known to confer a clinical benefit for their disease, or they have exhausted all
      such available options in each indication and therefore will be patients for whom a clinical
      trial is appropriate.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1)
time frame: Up to 48 months
measure: Tolerability: Number of dose interruptions, reductions and dose intensity (Phase 1)
time frame: Up to 48 months
measure: Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Phase 2)
time frame: Up to 48 months
measure: Incidence of Dose Limiting Toxicities (DLTs) with KY1044 as single agent (Phase 1)
time frame: Within first 21 days of treatment
measure: Incidence of DLTs with KY1044 in combination with atezolizumab (Phase 1)
time frame: Within first 21 days of treatment
measure: Best overall response (BOR) per RECIST 1.1
time frame: Up to 48 months
measure: Progression Free Survival (PFS) per RECIST 1.1
time frame: Up to a PFS event, approximately every 3 months
measure: Duration of Response (DOR) per RECIST 1.1
time frame: Up to a PFS event, approximately every 3 months
measure: ORR per Immune-Related Response Evaluation Criteria in Solid Tumors (iRECIST) (Phase 1 and Phase 2)
time frame: Up to 48 months
measure: PFS per iRECIST (Phase 1 and Phase 2)
time frame: Up to 48 months
measure: ORR per RECIST 1.1 (Phase 1)
time frame: Up to 48 months
measure: Survival rate
time frame: At 12 and 24 months
measure: Safety: Incidence and severity of AEs and SAEs (Phase 2)
time frame: Up to 48 months
measure: Number of dose interruptions, reductions and dose intensity (Phase 2)
time frame: Up to 48 months
measure: Maximum Concentration (Cmax) of KY1044 and of atezolizumab if in combination
time frame: Up to 48 months
measure: Half-life (t1/2) of of KY1044 and of atezolizumab if in combination
time frame: Up to 48 months
measure: Number of participants with anti-KY1044 and anti-atezolizumab antibodies
time frame: Up to 48 months
measure: Number of participants with presence of tumor-infiltrating lymphocytes (TILs) as determined by expression of ICOS (Inducible T cell Costimulator), FOXP3 (Forkhead box P3) and CD8 cells
time frame: Up to 48 months
arm group label: KY1044 monotherapy phase 1
arm group type: Experimental
description: KY1044 monotherapy dose escalation
arm group label: KY1044 and atezolizumab phase 1
arm group type: Experimental
description: KY1044 and atezolizumab combination dose escalation
arm group label: KY1044 monotherapy phase 2
arm group type: Experimental
description: KY1044 monotherapy
arm group label: KY1044 and atezolizumab phase 2
arm group type: Experimental
description: KY1044 and atezolizumab combination
intervention type: Drug
intervention name: KY1044
description: A human anti-ICOS monoclonal antibody
arm group label: KY1044 monotherapy phase 1
arm group label: KY1044 monotherapy phase 2
intervention type: Drug
intervention name: KY1044 and atezolizumab
description: A human anti-ICOS monoclonal antibody in combination with anti-PD-L1 monoclonal antibody (atezolizumab)
arm group label: KY1044 and atezolizumab phase 1
arm group label: KY1044 and atezolizumab phase 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
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country: Hungary
country: Italy
country: Poland
country: Taiwan
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
mesh term: Triple Negative Breast Neoplasms
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Atezolizumab
sharing ipd: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at https://vivli.org