SGM-101 in Colorectal Brain Metastases.

Colorectal Neoplasms Clinical Trial

— SGM-CBM  

Official title:

A Feasibility Study of SGM-101, a Fluorochrome-labeled Anti-carcinoembryonic Antigen Monoclonal Antibody for the Intraoperative Detection of Colorectal Brain Metastases.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04755920
• Other study ID #: NL74956.058.20
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2024
• Est. completion date: February 2026

Study information

• Verified date: May 2024
• Source: Leiden University Medical Center
• Contact: Mats Warmerdam, MD
• Phone: +31 71 5265 401
• Email: m.i.warmerdam[@]lumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study assesses the feasibility of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody, for intraoperative near-infrared fluorescence imaging of colorectal brain metastases by injecting SGM-101 intravenously 3 - 5 days prior to surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed informed consent prior to any study-mandated procedure;

2. Patients aged over 18 years old;

3. All women of child bearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment.

4. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.

5. Diagnosed with brain metastasis of colorectal origin and scheduled for a resection.

Exclusion Criteria:

1. History of any anaphylactic reaction;

2. Previous use of SGM-101;

3. Other malignancies either currently active or diagnosed in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma;

4. Laboratory abnormalities defined as:

1. Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;

2. Total bilirubin above 2 times the ULN or;

3. Serum creatinine above 1.5 times the ULN or;

4. Platelet count below 100 x 109/L or;

5. Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);

6. 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. Patients pregnant or breastfeeding;

6. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.

Related Conditions & MeSH terms

• Brain Cancer
• Brain Diseases
• Brain Metastases
• Brain Neoplasms
• Brain Tumor
• Colorectal Neoplasms
• Digestive System Diseases
• Digestive System Neoplasms
• Gastrointestinal Cancer
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Gastrointestinal Neoplasms
• Intestinal Disease
• Intestinal Diseases
• Intestinal Neoplasms
• Neoplasm Metastasis
• Neoplasms
• Rectal Neoplasms
• Rectum Cancer

Intervention

Drug:
• SGM-101
Fluorescence-guided surgery

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Medical Center Haaglanden	The Hague

Sponsors (3)

Lead Sponsor	Collaborator
Leiden University Medical Center	Medical Center Haaglanden, Surgimab

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the feasibility of SGM-101 for intraoperative imaging of colorectal brain metastases.	Concordance between the fluorescent signal and the tumor status (incl. degree of CEA-expression) of resected tissue; Concordance between the fluorescent signal and the resection margin with the use of neuronavigation	Intraoperative