SGM-101 in Colorectal Brain Metastases. (SGM-CBM)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Diseases; Gastrointestinal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Brain Neoplasms; Rectal Neoplasms; Brain Cancer; Brain Tumor; Gastrointestinal Cancer; Brain Metastases; Gastrointestinal Disease; Intestinal Disease; Rectum Cancer
• Intervention / Treatment: Drug: SGM-101

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mats Warmerdam, MD; Phone Number: +31 71 5265 401; Email: m.i.warmerdam@lumc.nl

Study Locations

• Netherlands
  • Leiden, Netherlands, 2333 ZA
    • Recruiting
    • Leiden University Medical Center
    • Contact: Alexander Vahrmeijer, MD, PhD
  • The Hague, Netherlands, 2512 VA
    • Recruiting
    • Medical Center Haaglanden
    • Contact: Marike Broekman, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with colorectal brain metastases; 10 mg SGM-101, administration 3 to 5 days prior to surgery.	Drug: SGM-101; Fluorescence-guided surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Collaborators: Medical Center Haaglanden; Surgimab

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: February 14, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Colonic Diseases; Rectal Diseases; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms; Colorectal Neoplasms; Neoplasm Metastasis; Rectal Neoplasms; Brain Neoplasms; Brain Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Intestinal Diseases; Intestinal Neoplasms
• Other Study ID Numbers: NL74956.058.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No