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

April 23, 2024 updated by: Surgimab

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
  • Italy
    • Lombardia
      • Pavia, Lombardia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo
        • Contact:
        • Principal Investigator:
          • Andrea Pietrabissa, MD
  • Netherlands
      • Eindhoven, Netherlands
      • Leiden, Netherlands, 2333 CL
        • Recruiting
        • Leiden University Medical Center
        • Contact:
        • Contact:
      • Rotterdam, Netherlands, 3015
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope National Medical Center
        • Contact:
          • Thinzar Lwin, MD, MS
          • Phone Number: 626-613-6032
          • Email: tlwin@coh.org
        • Principal Investigator:
          • Thinzar Lwin, MD, MS
      • La Jolla, California, United States, 92093
        • Recruiting
        • Moores Cancer Center - UCSD Health
        • Contact:
        • Contact:
          • Dad Shakeela, Ph.D.
          • Phone Number: (858) 822-5376
          • Email: 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
    • Florida
      • Weston, Florida, United States, 33331
        • Recruiting
        • Cleveland Clinic Florida
        • Contact:
        • Contact:
          • Maria MEJIA, BS, CCRP
          • Phone Number: (954) 659-5888
          • Email: MEJIAGM@ccf.org
        • Principal Investigator:
          • David J Maron, MD
        • Sub-Investigator:
          • Steven Wexner, MD
        • Sub-Investigator:
          • Giovanna DaSilva, MD
        • Sub-Investigator:
          • Dana Sands, MD
        • Sub-Investigator:
          • Conrad Simpfendorfer, MD
        • Sub-Investigator:
          • Mayank Roy, MD
        • Sub-Investigator:
          • Eric Weiss, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Not yet recruiting
        • Massachusetts General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rocco Ricciardi, MD
        • Sub-Investigator:
          • Horoko Kunitake, MD
        • Sub-Investigator:
          • Richard Hodin, MD
        • Sub-Investigator:
          • Liliana Bordeianou, MD
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • University of Massachusetts
        • Principal Investigator:
          • Karim Alavi, MD
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Perelman Center for Advanced Medicine
        • Contact:
        • Sub-Investigator:
          • Najjia Mahmoud, MD
        • Principal Investigator:
          • Sunil Singhal, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical resection histopathology.
Time Frame: Through completion of surgery, up to 9 weeks.
Comparison of surgical resections using histopathology as standard of truth..
Through completion of surgery, up to 9 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Surgimab

Investigators

  • Principal Investigator: Alex L. Vahrmeijer,, MD, PhD, Leiden University Medical Center, Leiden, The Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2019

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 4, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGM-CLIN03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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