SGM-101 in Colorectal Brain Metastases.

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Feb 14, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SGM-101, which is designed to help doctors see colorectal cancer that has spread to the brain during surgery. The treatment involves giving SGM-101 through an injection into the vein 3 to 5 days before the surgery. The goal is to determine if this method can make it easier for surgeons to identify and remove cancerous areas in the brain.

To participate in this study, you need to be over 18 years old and have been diagnosed with brain metastasis (cancer that has spread to the brain) from colorectal cancer. You should also be scheduled for surgery to remove this cancer. Before joining, you'll need to sign a consent form and be able to communicate in Dutch with the study team. Participants should not have certain health issues, like a history of severe allergic reactions or other active cancers. If you join the trial, you'll be closely monitored during the study to ensure your safety and well-being.

Gender

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Eligibility criteria

• 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.