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

Colorectal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03659448
• Other study ID #: SGM-CLIN03
• Status: Recruiting
• Phase: Phase 3
• Start date: June 17, 2019
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Surgimab
• Contact: John Warner, JD, MPA
• Phone: 8123257657
• Email: johna.warner[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Recurrence

Intervention

Drug:
• SGM-101
A fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent.

Locations

Country	Name	City	State
Germany	Universita¨tsmedizin Go¨ttingen, Klinik fu¨r Allgemein- Viszeral- und Kinderchirurgie	Göttingen
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia	Lombardia
Netherlands	Catharina Ziekenhuis Eindhoven	Eindhoven
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Erasmus MC	Rotterdam
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	City of Hope National Medical Center	Duarte	California
United States	Moores Cancer Center - UCSD Health	La Jolla	California
United States	Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania
United States	Cleveland Clinic Florida	Weston	Florida
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Surgimab

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical resection histopathology.	Comparison of surgical resections using histopathology as standard of truth..	Through completion of surgery, up to 9 weeks.