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

Primary Purpose

Colorectal Neoplasms

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SGM-101
Sponsored by
Surgimab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colorectal Neoplasms focused on measuring Fluorescence, Cancer, SGM-101, Surgery, Colorectal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Moores Cancer Center - UCSD HealthRecruiting
  • Cleveland Clinic FloridaRecruiting
  • Massachusetts General Hospital
  • University of MassachusettsRecruiting
  • Perelman Center for Advanced MedicineRecruiting
  • Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und KinderchirurgieRecruiting
  • Fondazione IRCCS Policlinico San MatteoRecruiting
  • Catharina Ziekenhuis EindhovenRecruiting
  • Leiden University Medical CenterRecruiting
  • Erasmus MCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Treatment

No Treatment

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 4, 2018
Last Updated
May 4, 2022
Sponsor
Surgimab
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1. Study Identification

Unique Protocol Identification Number
NCT03659448
Brief Title
Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2019 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Surgimab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Fluorescence, Cancer, SGM-101, Surgery, Colorectal

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No Treatment
Arm Type
No Intervention
Arm Description
Patients will not be administered the study drug, SGM-101, and will undergo surgical resections under standard :white light" conditions only.
Intervention Type
Drug
Intervention Name(s)
SGM-101
Intervention Description
A fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent.
Primary Outcome Measure Information:
Title
Surgical resection histopathology.
Description
Comparison of surgical resections using histopathology as standard of truth..
Time Frame
Through completion of surgery, up to 9 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Warner, JD, MPA
Phone
8123257657
Email
johna.warner@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Françoise Cailler, PhD
Phone
+33 467 798 381
Email
fcailler@surgimab.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex L. Vahrmeijer,, MD, PhD
Organizational Affiliation
Leiden University Medical Center, Leiden, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moores Cancer Center - UCSD Health
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia L Ramamoorthy, MD
Phone
858-657-6100
Email
sramamoorthy@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Dad Shakeela, Ph.D.
Phone
(858) 822-5376
Email
sdad@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Sonia L Ramamoorthy, MD
First Name & Middle Initial & Last Name & Degree
Andrew Lowy, MD
First Name & Middle Initial & Last Name & Degree
Joel Baumgartner, MD
First Name & Middle Initial & Last Name & Degree
Rebekah White, MD
First Name & Middle Initial & Last Name & Degree
Kaitlyn Kelly, MD
First Name & Middle Initial & Last Name & Degree
Jason Sicklick, MD
First Name & Middle Initial & Last Name & Degree
Nicole Lopez, MD
First Name & Middle Initial & Last Name & Degree
Jula Veerapong, MD
First Name & Middle Initial & Last Name & Degree
Samuel Eisenstein, MD
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David J MARON, MD
Phone
954-659-5278
Email
MAROND@ccf.org
First Name & Middle Initial & Last Name & Degree
Maria MEJIA, BS, CCRP
Phone
(954) 659-5888
Email
MEJIAGM@ccf.org
First Name & Middle Initial & Last Name & Degree
David J Maron, MD
First Name & Middle Initial & Last Name & Degree
Steven Wexner, MD
First Name & Middle Initial & Last Name & Degree
Eric Weiss, MD
First Name & Middle Initial & Last Name & Degree
Giovanna DaSilva, MD
First Name & Middle Initial & Last Name & Degree
Dana Sands, MD
First Name & Middle Initial & Last Name & Degree
Conrad Simpfendorfer, MD
First Name & Middle Initial & Last Name & Degree
Mayank Roy, MD
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rocco Ricciardi, MD
Email
RRICCIARDI1@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Caitlin Stafford
Phone
617-643-7869
Email
CSTAFFORD2@partners.org
First Name & Middle Initial & Last Name & Degree
Rocco Ricciardi, MD
First Name & Middle Initial & Last Name & Degree
Horoko Kunitake, MD
First Name & Middle Initial & Last Name & Degree
Richard Hodin, MD
First Name & Middle Initial & Last Name & Degree
Liliana Bordeianou, MD
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Balcom, RN
Phone
508-334-4918
Email
Sharon.Balcom@umassmed.edu
First Name & Middle Initial & Last Name & Degree
Karim Alavi, MD
Facility Name
Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunil Singhal, MD
Email
Sunil.Singhal@uphs.upenn.edu
First Name & Middle Initial & Last Name & Degree
Najjia Mahmoud, MD
First Name & Middle Initial & Last Name & Degree
Sunil Singhal, MD
Facility Name
Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und Kinderchirurgie
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Sperling, MD
Phone
+49 551 39 7989
Email
Jens.Sperling@med.uni-goettingen.de
First Name & Middle Initial & Last Name & Degree
Johanna Kreutzer, Ph.D.
Email
johanna.kreutzer@med.uni-goettingen.de
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Pugliese, MD
Email
luipugliese@gmail.com
First Name & Middle Initial & Last Name & Degree
Andrea Pietrabissa, MD
Facility Name
Catharina Ziekenhuis Eindhoven
City
Eindhoven
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H J Rutten, MD, PhD
Phone
+31 40 2397150
Email
harm.rutten@catharinaziekenhuis.nl
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333 CL
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander L Vahrmeijer, MD, Ph.D.
Phone
+31 71 5262309
Email
a.l.vahrmeijer@lumc.nl
First Name & Middle Initial & Last Name & Degree
Ruben P Meijer, MD
Phone
‭+31 71 7517143
Email
R.P.J.Meijer@lumc.nl
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cornelis Verhoef, MD
Email
c.verhoef@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Job Kooten, MD
Email
j.kooten@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Cornelis Verhoef, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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