RecruitingPhase 2NCT04755920

SGM-101 in Colorectal Brain Metastases.

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

Sponsor

Leiden University Medical Center

Enrollment

10 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Colorectal Neoplasms Gastrointestinal Cancer Brain Metastases Brain Neoplasms Brain Diseases Brain Tumor Brain Cancer Rectum Cancer Rectal Neoplasms Gastrointestinal Neoplasms Intestinal Neoplasms Gastrointestinal Disease Intestinal Disease

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Signed informed consent prior to any study-mandated procedure;
Patients aged over 18 years old;
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.
Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
Diagnosed with brain metastasis of colorectal origin and scheduled for a resection.

Exclusion Criteria12

History of any anaphylactic reaction;
Previous use of SGM-101;
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;
Laboratory abnormalities defined as:
Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;
Total bilirubin above 2 times the ULN or;
Serum creatinine above 1.5 times the ULN 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;
Patients pregnant or breastfeeding;
Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.