Status:
UNKNOWN
SGM-101 in Colorectal Lung Metastases
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Erasmus Medical Center
Surgimab
Conditions:
Colorectal Cancer
Metastatic Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Near-infrared fluorescence-guided oncologic surgery (FGOS) with the use of a tumor specific tracer (SGM-101) developed by Surgimab can provide valuable intra-operative information about tumor location...
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 lung metastasis of colorectal origin and scheduled for a resection.
Exclusion
- History of any anaphylactic reaction;
- 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 (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate);
- Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
- Previous SGM-101 use
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04737213
Start Date
November 1 2020
End Date
December 1 2021
Last Update
February 3 2021
Active Locations (2)
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1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZA
2
Erasmus Medical Center
Rotterdam, Netherlands