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

NCT03659448 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: SGM-CLIN03
• Study Type: interventional
• Target: 300
• Locations: 4 countries
• Sites: 11

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.

Conditions

Colorectal Neoplasms

Keywords

Fluorescence; Cancer; SGM-101; Surgery; Colorectal

Outcome Measures

Primary Outcomes (1)

• Surgical resection histopathology.

  Comparison of surgical resections using histopathology as standard of truth..

  Through completion of surgery, up to 9 weeks.

Study Arms (2)

Treatment

ACTIVE COMPARATOR

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

No Treatment

NO INTERVENTION

Patients will not be administered the study drug, SGM-101, and will undergo surgical resections under standard :white light" conditions only.

Interventions

SGM-101 DRUG

A fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Primary appendiceal cancer;
• 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);
• 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;
• Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.

Sponsors & Collaborators

• Surgimab: lead

Study Sites (11)

City of Hope National Medical Center

Duarte, California, 91010, United States

RECRUITING

Moores Cancer Center - UCSD Health

La Jolla, California, 92093, United States

RECRUITING

Cleveland Clinic Florida

Weston, Florida, 33331, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

University of Massachusetts

Worcester, Massachusetts, 01655, United States

RECRUITING

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und Kinderchirurgie

Göttingen, 37075, Germany

RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

RECRUITING

Catharina Ziekenhuis Eindhoven

Eindhoven, Netherlands

RECRUITING

Leiden University Medical Center

Leiden, 2333 CL, Netherlands

RECRUITING

Erasmus MC

Rotterdam, 3015, Netherlands

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Alex L. Vahrmeijer,, MD, PhD

  Leiden University Medical Center, Leiden, The Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Warner, JD, MPA

CONTACT

8123257657; johna.warner@outlook.com

Françoise Cailler, PhD

CONTACT

+33 467 798 381; fcailler@surgimab.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: September 6, 2018
• Study Start: June 17, 2019
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); IT (1); US (6); NL (3)