Status:
RECRUITING
SGM-101 in Colorectal Brain Metastases.
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Medical Center Haaglanden
Surgimab
Conditions:
Rectal Neoplasms
Rectum Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 meta...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04755920
Start Date
January 1 2024
End Date
February 1 2026
Last Update
May 9 2024
Active Locations (2)
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1
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA
2
Medical Center Haaglanden
The Hague, Netherlands, 2512 VA