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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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03659448 |
Recruitment Status :
Recruiting
First Posted : September 6, 2018
Last Update Posted : May 5, 2022
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Condition or disease | Intervention/treatment | Phase |
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Colorectal Neoplasms | Drug: SGM-101 | Phase 3 |
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 2023 |
Estimated Study Completion Date : | December 2023 |
Arm | Intervention/treatment |
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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.
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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.
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- Surgical resection histopathology. [ Time Frame: Through completion of surgery, up to 9 weeks. ]Comparison of surgical resections using histopathology as standard of truth..

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- 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;
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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.

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
Contact: John Warner, JD, MPA | 8123257657 | johna.warner@outlook.com | |
Contact: Françoise Cailler, PhD | +33 467 798 381 | fcailler@surgimab.com |
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 |
Principal Investigator: | Alex L. Vahrmeijer,, MD, PhD | Leiden University Medical Center, Leiden, The Netherlands |
Responsible Party: | Surgimab |
ClinicalTrials.gov Identifier: | NCT03659448 |
Other Study ID Numbers: |
SGM-CLIN03 |
First Posted: | September 6, 2018 Key Record Dates |
Last Update Posted: | May 5, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Fluorescence Cancer SGM-101 Surgery Colorectal |
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 |