<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/NCT02973672</url>
  </required_header>
  <id_info>
    <org_study_id>SGM-CLIN02</org_study_id>
    <nct_id>NCT02973672</nct_id>
  </id_info>
  <brief_title>Phase I of SGM-101 in Patients With Cancer of the Colon, Rectum or Pancreas</brief_title>
  <official_title>A Phase I Study Assessing the Safety and Performance of SGM-101, a Fluorochrome-labeled Anti-carcino-embryonic Antigen Monoclonal Antibody for the Detection of Neoplastic Lesions in Patients With Colorectal Cancer or Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Surgimab</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre for Human Drug Research, Netherlands</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Leiden University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Catharina Ziekenhuis Eindhoven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Surgimab</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the safety and performance of SGM-101, a Carcinoembryonic Antigen&#xD;
      (CEA)-specific chimeric antibody conjugated with a NIR emitting fluorochrome, for the&#xD;
      visualization of CEA-expressing cancers during surgery. SGM-101 is injected 2 to 4 days&#xD;
      before surgery and visualized using an optimized camera system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgery is the most important therapy for patients with cancer of the colon, rectum or&#xD;
      pancreas. Complete resection, which is a crucial factor in the prognosis of a patient, is&#xD;
      challenging as surgeons have to rely on visual appearance and palpation to discriminate&#xD;
      between tumor and normal tissue.&#xD;
&#xD;
      Carcinoembryonic antigen (CEA) is a tumor-specific marker that is highly expressed in a&#xD;
      number of tumors of epithelial origin (such as colorectal carcinoma and pancreas carcinoma)&#xD;
      while it is minimally expressed in normal adult tissues. The compound that will be studied in&#xD;
      this research project is SGM-101, a CEA-specific chimeric antibody conjugated with a&#xD;
      near-infrared (NIR) emitting moiety. The hypothesis is that, following preoperative iv&#xD;
      administration of SGM-101 in patients with carcinoma of the colon, rectum or pancreas,&#xD;
      SGM-101 will bind to CEA expressing cancer cells and these cells can then be visualized with&#xD;
      a NIR fluorescence imaging system, thereby increasing the chance of radical resection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">April 15, 2019</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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with treatment-related adverse events</measure>
    <time_frame>up to 10 days after the surgery</time_frame>
    <description>An Adverse Event (AE) is any untoward medical occurrence in a subject who is participating in a clinical study performed. The adverse event does not necessarily have to follow the administration of a study drug, or to have a causal relationship with the study drug. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory or vital sign finding), symptom, or disease temporally associated with the study participation, whether or not it is related to the study drug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tumor-to-background ratio (TBR) for fluorescence</measure>
    <time_frame>day 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum SGM-101 concentrations</measure>
    <time_frame>up to 1 month after surgery</time_frame>
    <description>Individual serum SGM-101 concentrations will be plotted versus time per individual using both a linear and log y-axis. Additionally, concentration versus time curves will be plotted per treatment group as a spaghetti plot.&#xD;
Concentrations will be summarized by treatment group.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Colon Cancer</condition>
  <condition>Rectum Cancer</condition>
  <condition>Pancreas Cancer</condition>
  <condition>Metastatic Colorectal Cancer</condition>
  <condition>Recurrent Colorectal Carcinoma</condition>
  <arm_group>
    <arm_group_label>SGM-101</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SGM-101</intervention_name>
    <description>4 days before surgery, SGM-101 will be administered to the patient by intravenous injections.</description>
    <arm_group_label>SGM-101</arm_group_label>
    <other_name>SGM 101</other_name>
    <other_name>SGM101</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged over 18 years old;&#xD;
&#xD;
          -  Patient should be scheduled and eligible for surgery because of a clinical diagnosis&#xD;
             of cancer of the colon, rectum or cancer of the pancreas;&#xD;
&#xD;
          -  Both pancreatic and colorectal cancer patients: Circulating plasma CEA ≥ the upper&#xD;
             limit of normal range (eg ≥ 3.0 ng / ml);&#xD;
&#xD;
          -  Patient suffering from recurrences and metastasis of colorectal cancer: Rising&#xD;
             circulating plasma CEA&#xD;
&#xD;
          -  Patients should be capable and willing to give informed consent before study specific&#xD;
             procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anticancer therapy (e.g. chemotherapy, radiotherapy (except for routine pre-operative&#xD;
             radiotherapy for colorectal cancer), targeted therapy, concomitant systemic immune&#xD;
             therapy, or any experimental therapy) within 4 weeks before inclusion;&#xD;
&#xD;
          -  History of a clinically significant allergy;&#xD;
&#xD;
          -  Circulating plasma concentration CEA ≥ 300 ng / ml;&#xD;
&#xD;
          -  Other malignancies either currently active or diagnosed in the last 5 years, except&#xD;
             adequately treated in situ carcinoma of the cervix and basal or squamous cell skin&#xD;
             carcinoma;&#xD;
&#xD;
          -  Patients pregnant or breastfeeding (pregnancy should be ruled out by an assay of βhCG&#xD;
             plasma within 4±1 weeks prior to administration of the conjugate), lack of effective&#xD;
             contraception in male or female patients with reproductive potential;&#xD;
&#xD;
          -  Laboratory abnormalities defined as:&#xD;
&#xD;
        Colorectal cancer patients only:&#xD;
&#xD;
          -  Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or&#xD;
             Alkaline Phosphatase levels above 5 times the or;&#xD;
&#xD;
          -  Total bilirubin above 2 times the Upper Limit Normal (ULN) or; Both pancreatic and&#xD;
             colorectal cancer patients:&#xD;
&#xD;
          -  Serum creatinine above 1.5 times the ULN or;&#xD;
&#xD;
          -  Absolute neutrophils counts below 1.5 x 109/L or;&#xD;
&#xD;
          -  Platelet count below 100 x 109/L or;&#xD;
&#xD;
          -  Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);&#xD;
&#xD;
          -  Known positive test for human immunodeficiency virus (HIV), hepatitis B surface&#xD;
             antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious&#xD;
             infections;&#xD;
&#xD;
          -  Any condition that the investigator considers to be potentially jeopardizing the&#xD;
             patients' wellbeing or the study objectives.&#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>Alexander L Vahrmeijer, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Leiden University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Catharina Ziekenhuis Eindhoven</name>
      <address>
        <city>Eindhoven</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leiden University Medical Center</name>
      <address>
        <city>Leiden</city>
        <zip>2333 CL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medical Center Cancer Institute</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>July 16, 2019</last_update_submitted>
  <last_update_submitted_qc>July 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fluorescence</keyword>
  <keyword>Surgery</keyword>
  <keyword>Cancer</keyword>
  <keyword>SGM-101</keyword>
  <keyword>Near Infrared</keyword>
  <keyword>Immunophotodetection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Rectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02973672
org study id: SGM-CLIN02
nct id: NCT02973672
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This study evaluates the safety and performance of SGM-101, a Carcinoembryonic Antigen
      (CEA)-specific chimeric antibody conjugated with a NIR emitting fluorochrome, for the
      visualization of CEA-expressing cancers during surgery. SGM-101 is injected 2 to 4 days
      before surgery and visualized using an optimized camera system.
Surgery is the most important therapy for patients with cancer of the colon, rectum or
      pancreas. Complete resection, which is a crucial factor in the prognosis of a patient, is
      challenging as surgeons have to rely on visual appearance and palpation to discriminate
      between tumor and normal tissue.

      Carcinoembryonic antigen (CEA) is a tumor-specific marker that is highly expressed in a
      number of tumors of epithelial origin (such as colorectal carcinoma and pancreas carcinoma)
      while it is minimally expressed in normal adult tissues. The compound that will be studied in
      this research project is SGM-101, a CEA-specific chimeric antibody conjugated with a
      near-infrared (NIR) emitting moiety. The hypothesis is that, following preoperative iv
      administration of SGM-101 in patients with carcinoma of the colon, rectum or pancreas,
      SGM-101 will bind to CEA expressing cancer cells and these cells can then be visualized with
      a NIR fluorescence imaging system, thereby increasing the chance of radical resection.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of patients with treatment-related adverse events
time frame: up to 10 days after the surgery
description: An Adverse Event (AE) is any untoward medical occurrence in a subject who is participating in a clinical study performed. The adverse event does not necessarily have to follow the administration of a study drug, or to have a causal relationship with the study drug. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory or vital sign finding), symptom, or disease temporally associated with the study participation, whether or not it is related to the study drug.
measure: Tumor-to-background ratio (TBR) for fluorescence
time frame: day 4
measure: Serum SGM-101 concentrations
time frame: up to 1 month after surgery
description: Individual serum SGM-101 concentrations will be plotted versus time per individual using both a linear and log y-axis. Additionally, concentration versus time curves will be plotted per treatment group as a spaghetti plot.
Concentrations will be summarized by treatment group.
arm group label: SGM-101
arm group type: Experimental
intervention type: Drug
intervention name: SGM-101
description: 4 days before surgery, SGM-101 will be administered to the patient by intravenous injections.
arm group label: SGM-101
other name: SGM 101
other name: SGM101
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexander L Vahrmeijer, MD, PhD
role: Principal Investigator
affiliation: Leiden University Medical Center
facility: 
facility: 
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Pancreatic Neoplasms
mesh term: Rectal Neoplasms
sharing ipd: No