SGM-101 in Colorectal Brain Metastases.

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04755920
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Leiden University Medical Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Not yet recruiting
Countries	Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rectal Neoplasms, Rectum Cancer, Colorectal Neoplasms, Brain Metastases, Brain Neoplasms, Brain Diseases, Brain Cancer, Brain Tumor, Intestinal Neoplasms, Gastrointestinal Neoplasms, Gastrointestinal Cancer, Gastrointestinal Disease, Intestinal Disease

Arms & Interventions

Arms

Experimental: Patients with colorectal brain metastases

10 mg SGM-101, administration 3 to 5 days prior to surgery.

Interventions

Drug: - SGM-101

Fluorescence-guided surgery

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Leiden University Medical Center, Leiden, Netherlands

Status

Address

Leiden University Medical Center

Leiden, , 2333 ZA

Site Contact

Alexander Vahrmeijer, MD, PhD

r.a.faber@lumc.nl

+31 71 5265 401

Medical Center Haaglanden, The Hague, Netherlands

Status

Address

Medical Center Haaglanden

The Hague, , 2512 VA

Site Contact

Marike Broekman, MD, PhD

r.a.faber@lumc.nl

+31 71 5265 401

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