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Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT03659448
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Surgimab

Study Description
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Brief Summary:
The performance of SGM-101, an intraoperative imaging agent, will be compared to that of standard "white light" visualization during surgical resections of colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: SGM-101 Phase 3

Detailed Description:
The performance of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent for the delineation of primary and recurrent tumor and metastases in patients undergoing curative surgery for colorectal cancer will be compared to that of standard "white light" visualization in a multicenter, open-label, randomized, controlled, parallel arms clinical study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two parallel arms consisting of a treatment arm of patients who will receive the study drug and subsequently undergo surgical resections under both "standard "white light" conditions and then NIR, and a no treatment arm to whom the study drug will not be administered and who will undergo surgical resections under standard "white light" conditions only.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Multicenter, Open-label, Randomized, Controlled, Parallel Arms Clinical Study on Performance of SGM-101, a Fluorochrome-labeled Anti-CEA Monoclonal Antibody, for Delineation of Primary/Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Treatment
Patients will receive a single dose of the study drug, SGM-101, and subsequently undergo surgical resections under both "standard "white light" conditions and then NIR.
 Drug: SGM-101
A fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent.
No Intervention: No Treatment
Patients will not be administered the study drug, SGM-101, and will undergo surgical resections under standard :white light" conditions only.


Outcome Measures
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Primary Outcome Measures :
  1. Surgical resection histopathology. [ Time Frame: Through completion of surgery, up to 9 weeks. ]
    Comparison of surgical resections using histopathology as standard of truth..


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients should be scheduled for curative colorectal cancer surgery of primary cT4 colon cancer or primary cT3/4 rectal cancer, recurrent colorectal cancer or peritoneal metastasized colorectal cancer.
  • Female patients must be of non-child-bearing potential (i.e., women with functioning ovaries who have a documented tubal ligation or hysterectomy, ovariectomy or women who are post-menopausal). Women of child-bearing potential will be included provided that they have a negative urine pregnancy test at the day of the injection and agree to practice adequate contraception for 30 days prior to administration of investigational product, and 30 days after completion of injection.

Exclusion Criteria:

  1. Other malignancies, either currently active or diagnosed in the last 5 years, except for adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma;
  2. Primary appendiceal cancer;

  3. Laboratory abnormalities defined as:

    • Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the ULN or;
    • Total bilirubin above 2 times the ULN or;
    • Serum creatinine above 1.5 times the ULN or;
    • Absolute neutrophils counts below 1.5 x 109/L or;
    • Platelet count below 100 x 109/L or;
    • Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);
  4. Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections;
  5. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03659448


Contacts
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Contact: John Warner, JD, MPA 8123257657 johna.warner@outlook.com
Contact: Françoise Cailler, PhD +33 467 798 381 fcailler@surgimab.com

Locations
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United States, California
Moores Cancer Center - UCSD Health Recruiting
La Jolla, California, United States, 92093
Contact: Sonia L Ramamoorthy, MD    858-657-6100    sramamoorthy@ucsd.edu   
Contact: Dad Shakeela, Ph.D.    (858) 822-5376    sdad@ucsd.edu   
Principal Investigator: Sonia L Ramamoorthy, MD         
Sub-Investigator: Andrew Lowy, MD         
Sub-Investigator: Joel Baumgartner, MD         
Sub-Investigator: Rebekah White, MD         
Sub-Investigator: Kaitlyn Kelly, MD         
Sub-Investigator: Jason Sicklick, MD         
Sub-Investigator: Nicole Lopez, MD         
Sub-Investigator: Jula Veerapong, MD         
Sub-Investigator: Samuel Eisenstein, MD         
United States, Florida
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: David J MARON, MD    954-659-5278    MAROND@ccf.org   
Contact: Maria MEJIA, BS, CCRP    (954) 659-5888    MEJIAGM@ccf.org   
Principal Investigator: David J Maron, MD         
Sub-Investigator: Steven Wexner, MD         
Sub-Investigator: Eric Weiss, MD         
Sub-Investigator: Giovanna DaSilva, MD         
Sub-Investigator: Dana Sands, MD         
Sub-Investigator: Conrad Simpfendorfer, MD         
Sub-Investigator: Mayank Roy, MD         
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Rocco Ricciardi, MD       RRICCIARDI1@mgh.harvard.edu   
Contact: Caitlin Stafford    617-643-7869    CSTAFFORD2@partners.org   
Principal Investigator: Rocco Ricciardi, MD         
Sub-Investigator: Horoko Kunitake, MD         
Sub-Investigator: Richard Hodin, MD         
Sub-Investigator: Liliana Bordeianou, MD         
University of Massachusetts Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Sharon Balcom, RN    508-334-4918    Sharon.Balcom@umassmed.edu   
Principal Investigator: Karim Alavi, MD         
United States, Pennsylvania
Perelman Center for Advanced Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sunil Singhal, MD       Sunil.Singhal@uphs.upenn.edu   
Sub-Investigator: Najjia Mahmoud, MD         
Principal Investigator: Sunil Singhal, MD         
Germany
Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und Kinderchirurgie Recruiting
Göttingen, Germany, 37075
Contact: Jens Sperling, MD    +49 551 39 7989    Jens.Sperling@med.uni-goettingen.de   
Contact: Johanna Kreutzer, Ph.D.       johanna.kreutzer@med.uni-goettingen.de   
Italy
Fondazione IRCCS Policlinico San Matteo Recruiting
Pavia, Lombardia, Italy, 27100
Contact: Luigi Pugliese, MD       luipugliese@gmail.com   
Principal Investigator: Andrea Pietrabissa, MD         
Netherlands
Catharina Ziekenhuis Eindhoven Recruiting
Eindhoven, Netherlands
Contact: H J Rutten, MD, PhD    +31 40 2397150    harm.rutten@catharinaziekenhuis.nl   
Leiden University Medical Center Recruiting
Leiden, Netherlands, 2333 CL
Contact: Alexander L Vahrmeijer, MD, Ph.D.    +31 71 5262309    a.l.vahrmeijer@lumc.nl   
Contact: Ruben P Meijer, MD    ‭+31 71 7517143    R.P.J.Meijer@lumc.nl   
Erasmus MC Recruiting
Rotterdam, Netherlands, 3015
Contact: Cornelis Verhoef, MD       c.verhoef@erasmusmc.nl   
Contact: Job Kooten, MD       j.kooten@erasmusmc.nl   
Principal Investigator: Cornelis Verhoef, MD         
Sponsors and Collaborators
Surgimab
Investigators
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Principal Investigator: Alex L. Vahrmeijer,, MD, PhD Leiden University Medical Center, Leiden, The Netherlands
More Information
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Responsible Party: Surgimab
ClinicalTrials.gov Identifier: NCT03659448    
Other Study ID Numbers: SGM-CLIN03
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Surgimab:
Fluorescence
Cancer
SGM-101
Surgery
Colorectal
Additional relevant MeSH terms:
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Colorectal Neoplasms
Recurrence
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathologic Processes
Disease Attributes