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

Sponsor

Surgimab (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03659448

Collaborator

(none)

300

Enrollment

Locations

Arms

53.5

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms	Drug: SGM-101	Phase 3

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 Design

Study Type:

Interventional

Anticipated 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.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 :

Jun 17, 2019

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Surgical resection histopathology. [Through completion of surgery, up to 9 weeks.]
Comparison of surgical resections using histopathology as standard of truth..

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moores Cancer Center - UCSD Health	La Jolla	California	United States	92093
2	Cleveland Clinic Florida	Weston	Florida	United States	33331
3	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
4	University of Massachusetts	Worcester	Massachusetts	United States	01655
5	Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania	United States	19104
6	Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und Kinderchirurgie	Göttingen		Germany	37075
7	Fondazione IRCCS Policlinico San Matteo	Pavia	Lombardia	Italy	27100
8	Catharina Ziekenhuis Eindhoven	Eindhoven		Netherlands
9	Leiden University Medical Center	Leiden		Netherlands	2333 CL
10	Erasmus MC	Rotterdam		Netherlands	3015