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NCT03659448PHASE3Recruiting

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

Surgimab

Start Date

6/17/2019

Completion Date

12/1/2024

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

SGM-101

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Conditions

Colorectal Neoplasms

Locations

City of Hope National Medical Center

Duarte, California 91010

United States

Moores Cancer Center - UCSD Health

La Jolla, California 92093

United States

Cleveland Clinic Florida

Weston, Florida 33331

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

University of Massachusetts

Worcester, Massachusetts 01655

United States

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania 19104

United States

Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und Kinderchirurgie

Göttingen, 37075

Germany

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy 27100

Italy

Catharina Ziekenhuis Eindhoven

Eindhoven,

Netherlands

Leiden University Medical Center

Leiden, 2333 CL

Netherlands

Erasmus MC

Rotterdam, 3015

Netherlands