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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Surgimab

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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