<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/NCT02187848</url>
  </required_header>
  <id_info>
    <org_study_id>TED13751</org_study_id>
    <secondary_id>2014-001130-29</secondary_id>
    <nct_id>NCT02187848</nct_id>
  </id_info>
  <brief_title>Evaluation of SAR408701 in Patients With Advanced Solid Tumors</brief_title>
  <official_title>A First-in-Human Study for the Evaluation of the Safety, Pharmacokinetics and Antitumor Activity of SAR408701 in Patients With Advanced Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objectives:&#xD;
&#xD;
        -  To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy,&#xD;
           once every 2 weeks (with and without a loading dose at Cycle 1) to patients with&#xD;
           advanced solid tumors (Main Escalation and Loading Dose Escalation Q2W).&#xD;
&#xD;
        -  To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy,&#xD;
           once every 3 weeks to patients with advanced solid tumors (Escalation Q3W Cycle).&#xD;
&#xD;
        -  To assess efficacy according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST&#xD;
           1.1) (Expansion Phase) when SAR408701 is administered once every 2 weeks with or without&#xD;
           a loading dose at Cycle 1.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To characterize the overall safety profile of SAR408701.&#xD;
&#xD;
        -  To characterize the pharmacokinetic (PK) profile of SAR408701 and of its potential&#xD;
           circulating derivatives.&#xD;
&#xD;
        -  To identify the recommended phase 2 dose (RP2D) of SAR408701.&#xD;
&#xD;
        -  To assess the potential immunogenicity of SAR408701.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study duration for an individual patient will start from the signature of the informed&#xD;
      consent, will include a period to assess eligibility (screening period) of up to&#xD;
      approximately 4 weeks (28 days), a treatment period and an end-of-treatment visit around 30&#xD;
      days following the last administration of study drug, and at least one follow-up visit after&#xD;
      the end-of-treatment visit. Additional follow-up visits may be required until resolution or&#xD;
      stabilization of adverse events (at least 30 days). Treatment may continue until precluded by&#xD;
      toxicity, progression, or upon patient's request. If the patient stops study treatment for&#xD;
      reason other than disease progression, follow-up visit will be performed every 3 months until&#xD;
      disease progression or initiation of another anti-tumor treatment or death, whichever comes&#xD;
      first.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 23, 2014</start_date>
  <completion_date type="Anticipated">August 31, 2023</completion_date>
  <primary_completion_date type="Actual">November 10, 2020</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>Number of dose limiting adverse events (every 2 week cycle)</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of overall response rate using standard imaging and RECIST 1.1 criteria</measure>
    <time_frame>Up to 40 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of dose limiting adverse events (every 3 week cycle)</measure>
    <time_frame>3 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of treatment emergent adverse events</measure>
    <time_frame>Up to 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum concentration (Cmax)</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach maximum concentration (tmax)</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough plasma concentrations (Ctrough)</measure>
    <time_frame>Intensive testing within first 2 months, then every 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve between 0 and 14 days (AUC0-14day) for Q2W or between 0 and 21 days (AUC-21 day) for Q3W</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean systemic clearance (CL)</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance at steady state (CLss)</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation ratio (Rac) on AUC0-14day and Cmax</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detection of the development of anti-SAR408701 antibody</measure>
    <time_frame>Up to 40 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>Up to 40 months - assessment every 6-8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Progression</measure>
    <time_frame>Up to 40 months - assessment every 6-8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>9</number_of_arms>
  <enrollment type="Actual">263</enrollment>
  <condition>Neoplasm Malignant</condition>
  <arm_group>
    <arm_group_label>SAR408701 Main Dose Escalation Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose escalation administered intravenously, once every two weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SAR408701 Expansion Cohort colorectal cancer (CRC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered intravenously at the maximum tolerated dose (MTD), once every 2 weeks, to patients with colorectal cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SAR408701 Expansion Cohort non-squamous NSCLC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered intravenously at the MTD, once every 2 weeks, to patients with carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) expressing non-squamous non-small cell lung cancer (NSCLC) of at least 50% of tumor cells at or above 2+ intensity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SAR408701 Expansion Cohort gastric adenocarcinoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing gastric adenocarcinoma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SAR408701 Loading Dose Escalation cohorts (Escalation bis)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Loading dose escalation administered intravenously at first cycle, followed by MTD, once every 2 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SAR408701 Expansion Cohort non-squamous NSCLC (Lung bis)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing non-squamous NSCLC of at least 1% but below 50% of tumor cells at or above 2+ intensity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SAR408701 Expansion Cohort colorectal cancer (CRC-L)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Loading dose of determined MTD-L administered intravenously at first cycle, followed by MTD, once every 2 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SAR408701 Expansion Cohort small cell lung cancer (SCLC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing SCLC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SAR408701 Dose Escalation every 3 weeks cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose escalation administered intravenously, once every three weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SAR408701</intervention_name>
    <description>Pharmaceutical form: concentrate for solution for infusion Route of administration: intravenous</description>
    <arm_group_label>SAR408701 Dose Escalation every 3 weeks cohort</arm_group_label>
    <arm_group_label>SAR408701 Expansion Cohort colorectal cancer (CRC)</arm_group_label>
    <arm_group_label>SAR408701 Expansion Cohort colorectal cancer (CRC-L)</arm_group_label>
    <arm_group_label>SAR408701 Expansion Cohort gastric adenocarcinoma</arm_group_label>
    <arm_group_label>SAR408701 Expansion Cohort non-squamous NSCLC</arm_group_label>
    <arm_group_label>SAR408701 Expansion Cohort non-squamous NSCLC (Lung bis)</arm_group_label>
    <arm_group_label>SAR408701 Expansion Cohort small cell lung cancer (SCLC)</arm_group_label>
    <arm_group_label>SAR408701 Loading Dose Escalation cohorts (Escalation bis)</arm_group_label>
    <arm_group_label>SAR408701 Main Dose Escalation Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Locally advanced or metastatic solid malignant tumor disease for which no standard&#xD;
             alternative therapy is available.&#xD;
&#xD;
          -  Availability of archived tumor tissue for carcinoembryonic antigen-related cell&#xD;
             adhesion molecule 5 (CEACAM5 or CEA) testing.&#xD;
&#xD;
          -  For participants in the Dose Escalation Cohorts (Main Escalation and Loading Dose&#xD;
             Cohorts at every 2 week cycle and Dose Escalation every 3 week cycle): patients with&#xD;
             tumors expressing or likely to be expressing CEACAM5 which includes colorectal cancer&#xD;
             (CRC), non-squamous non-small cell lung cancer (NSCLC), gastric adenocarcinoma,&#xD;
             squamous cell carcinoma of the cervix, pancreas adenocarcinoma, bladder transitional&#xD;
             cell carcinoma, cholangiocarcinoma, epithelial ovarian cancer and endometrial&#xD;
             adenocarcinoma are favored, or if carcinoembryonic antigen (CEA) plasma levels &gt;5&#xD;
             ng/mL.&#xD;
&#xD;
          -  For participants to the Expansion Phase cohorts: patients with CRC or with CEACAM5&#xD;
             positive non-squamous NSCLC, small cell lung cancer (SCLC) or gastric carcinoma&#xD;
             (including esophago-gastric junction adenocarcinoma of the Siewert types II and III).&#xD;
&#xD;
          -  At least one measurable lesion by RECIST v1.1 in the Expansion Phase only.&#xD;
&#xD;
          -  At least one lesion amenable to biopsy (Expansion cohort - CRC and gastric cancer&#xD;
             only). Patient must consent to a baseline biopsy for retrospective confirmation of&#xD;
             tumor CEACAM5 expression, except if NSCLC or SCLC without lesion amenable to biopsy.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Aged less than 18 years.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status more than 1.&#xD;
&#xD;
          -  New or progressing brain involvement.&#xD;
&#xD;
          -  Concurrent treatment with any other anticancer therapy or inadequate wash-out period&#xD;
             for prior anticancer therapies before first administration of SAR408701, or&#xD;
             non-resolution of toxicities induced by these anticancer therapies.&#xD;
&#xD;
          -  Female or male patients with reproductive potential who do not agree to use an&#xD;
             accepted effective method of contraception during the study treatment period and for&#xD;
             at least 3 months following completion of study treatment.&#xD;
&#xD;
          -  Pregnancy or breast-feeding.&#xD;
&#xD;
          -  Participation to any clinical research study evaluating another investigational drug&#xD;
             or therapy within 3 weeks of initiation of study regimen.&#xD;
&#xD;
          -  Prior therapy targeting CEACAM5.&#xD;
&#xD;
          -  Prior maytansinoid treatments (DM1 or DM4 antibody drug conjugates).&#xD;
&#xD;
          -  Poor bone marrow reserve resulting in low blood cell counts.&#xD;
&#xD;
          -  Poor kidney and liver functions.&#xD;
&#xD;
          -  Any of the following within 6 months prior to study enrolment: infectious or&#xD;
             inflammatory bowel disease, diverticulitis, gastrointestinal perforation, intestinal&#xD;
             obstruction, and gastrointestinal hemorrhage. Patients with malabsorption syndrome are&#xD;
             excluded.&#xD;
&#xD;
          -  Previous history and or unresolved corneal disorders. The use of contact lenses is not&#xD;
             permitted.&#xD;
&#xD;
          -  Unresolved signs and symptoms of neuropathy; Grade 1 is acceptable if prior neurotoxic&#xD;
             drugs such as cisplatin or taxanes.&#xD;
&#xD;
          -  Abnormal cardiac function defined by a left ventricular ejection fraction (LVEF) of&#xD;
             &lt;50%.&#xD;
&#xD;
          -  Cardiac conduction defects, or any other clinically significant arrhythmias.&#xD;
&#xD;
          -  Known intolerance to infused protein products.&#xD;
&#xD;
          -  Medical conditions requiring concomitant administration of medications with narrow&#xD;
             therapeutic window, metabolized by cytochrome P450 (CYPs) enzymes and for which a dose&#xD;
             reduction cannot be considered.&#xD;
&#xD;
          -  Medical conditions requiring concomitant administration of strong CYP3A inhibitor,&#xD;
             unless it can be discontinued at least 2 weeks before 1st administration of SAR408701.&#xD;
&#xD;
          -  Contraindications to the use of ophthalmic vasoconstrictor and/or corticosteroid as&#xD;
             per package insert of each drug, including the following: increase intraocular&#xD;
             pressure, prior or current glaucoma, narrow-angle glaucoma, ongoing eye infection,&#xD;
             uncontrolled hypertension, known/suspected allergy to constituents of the preparation&#xD;
             (such as sodium bisulfite).&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a patient's&#xD;
        potential participation in a clinical trial.&#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>Investigational Site Number 840006</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840003</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840002</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520-8017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840105</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840005</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 840001</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 124001</name>
      <address>
        <city>Toronto</city>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250003</name>
      <address>
        <city>Bordeaux Cedex</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250006</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250004</name>
      <address>
        <city>Marseille Cedex 5</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250007</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250005</name>
      <address>
        <city>Saint Mande</city>
        <zip>94163</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250002</name>
      <address>
        <city>Toulouse Cedex 9</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 250001</name>
      <address>
        <city>Villejuif Cedex</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 410002</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 410005</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 410003</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 410004</name>
      <address>
        <city>Seoul</city>
        <zip>07061</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 410001</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724001</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724007</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724004</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724006</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724003</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 724002</name>
      <address>
        <city>Majadahonda</city>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Korea, Republic of</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT02187848
org study id: TED13751
secondary id: 2014-001130-29
nct id: NCT02187848
lead sponsor: 
has dmc: No
Primary Objectives:

        -  To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy,
           once every 2 weeks (with and without a loading dose at Cycle 1) to patients with
           advanced solid tumors (Main Escalation and Loading Dose Escalation Q2W).

        -  To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy,
           once every 3 weeks to patients with advanced solid tumors (Escalation Q3W Cycle).

        -  To assess efficacy according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST
           1.1) (Expansion Phase) when SAR408701 is administered once every 2 weeks with or without
           a loading dose at Cycle 1.

      Secondary Objectives:

        -  To characterize the overall safety profile of SAR408701.

        -  To characterize the pharmacokinetic (PK) profile of SAR408701 and of its potential
           circulating derivatives.

        -  To identify the recommended phase 2 dose (RP2D) of SAR408701.

        -  To assess the potential immunogenicity of SAR408701.
The study duration for an individual patient will start from the signature of the informed
      consent, will include a period to assess eligibility (screening period) of up to
      approximately 4 weeks (28 days), a treatment period and an end-of-treatment visit around 30
      days following the last administration of study drug, and at least one follow-up visit after
      the end-of-treatment visit. Additional follow-up visits may be required until resolution or
      stabilization of adverse events (at least 30 days). Treatment may continue until precluded by
      toxicity, progression, or upon patient's request. If the patient stops study treatment for
      reason other than disease progression, follow-up visit will be performed every 3 months until
      disease progression or initiation of another anti-tumor treatment or death, whichever comes
      first.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of dose limiting adverse events (every 2 week cycle)
time frame: 4 weeks
measure: Assessment of overall response rate using standard imaging and RECIST 1.1 criteria
time frame: Up to 40 months
measure: Number of dose limiting adverse events (every 3 week cycle)
time frame: 3 weeks
measure: Number of treatment emergent adverse events
time frame: Up to 4 years
measure: Maximum concentration (Cmax)
time frame: 2 months
measure: Time to reach maximum concentration (tmax)
time frame: 2 months
measure: Trough plasma concentrations (Ctrough)
time frame: Intensive testing within first 2 months, then every 2 weeks
measure: Area under the plasma concentration versus time curve between 0 and 14 days (AUC0-14day) for Q2W or between 0 and 21 days (AUC-21 day) for Q3W
time frame: 2 months
measure: Mean systemic clearance (CL)
time frame: 2 months
measure: Clearance at steady state (CLss)
time frame: 2 months
measure: Accumulation ratio (Rac) on AUC0-14day and Cmax
time frame: 2 months
measure: Detection of the development of anti-SAR408701 antibody
time frame: Up to 40 months
measure: Duration of response
time frame: Up to 40 months - assessment every 6-8 weeks
measure: Time to Progression
time frame: Up to 40 months - assessment every 6-8 weeks
arm group label: SAR408701 Main Dose Escalation Cohort
arm group type: Experimental
description: Dose escalation administered intravenously, once every two weeks
arm group label: SAR408701 Expansion Cohort colorectal cancer (CRC)
arm group type: Experimental
description: Administered intravenously at the maximum tolerated dose (MTD), once every 2 weeks, to patients with colorectal cancer
arm group label: SAR408701 Expansion Cohort non-squamous NSCLC
arm group type: Experimental
description: Administered intravenously at the MTD, once every 2 weeks, to patients with carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) expressing non-squamous non-small cell lung cancer (NSCLC) of at least 50% of tumor cells at or above 2+ intensity
arm group label: SAR408701 Expansion Cohort gastric adenocarcinoma
arm group type: Experimental
description: Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing gastric adenocarcinoma
arm group label: SAR408701 Loading Dose Escalation cohorts (Escalation bis)
arm group type: Experimental
description: Loading dose escalation administered intravenously at first cycle, followed by MTD, once every 2 weeks
arm group label: SAR408701 Expansion Cohort non-squamous NSCLC (Lung bis)
arm group type: Experimental
description: Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing non-squamous NSCLC of at least 1% but below 50% of tumor cells at or above 2+ intensity
arm group label: SAR408701 Expansion Cohort colorectal cancer (CRC-L)
arm group type: Experimental
description: Loading dose of determined MTD-L administered intravenously at first cycle, followed by MTD, once every 2 weeks
arm group label: SAR408701 Expansion Cohort small cell lung cancer (SCLC)
arm group type: Experimental
description: Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing SCLC
arm group label: SAR408701 Dose Escalation every 3 weeks cohort
arm group type: Experimental
description: Dose escalation administered intravenously, once every three weeks
intervention type: Drug
intervention name: SAR408701
description: Pharmaceutical form: concentrate for solution for infusion Route of administration: intravenous
arm group label: SAR408701 Dose Escalation every 3 weeks cohort
arm group label: SAR408701 Expansion Cohort colorectal cancer (CRC)
arm group label: SAR408701 Expansion Cohort colorectal cancer (CRC-L)
arm group label: SAR408701 Expansion Cohort gastric adenocarcinoma
arm group label: SAR408701 Expansion Cohort non-squamous NSCLC
arm group label: SAR408701 Expansion Cohort non-squamous NSCLC (Lung bis)
arm group label: SAR408701 Expansion Cohort small cell lung cancer (SCLC)
arm group label: SAR408701 Loading Dose Escalation cohorts (Escalation bis)
arm group label: SAR408701 Main Dose Escalation Cohort
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: Canada
country: France
country: Korea, Republic of
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
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