SGM-101 in Colorectal Lung Metastases

Study Overview
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Brief Summary
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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 and extensiveness. SGM-101 already proven to be safe and valuable in colorectal cancer. This study aims to prove feasibility for colorectal lung metastases.

Official Title
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An Open-label, Exploratory Study Assessing the Feasibility of SGM-101, a Fluorochrome-labeled Anti-carcinoembryonic Antigen Monoclonal Antibody for the Intraoperative Detection of Lung Metastasis in Colorectal Cancer

Conditions
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Colorectal Cancer, Metastatic Colon Cancer

Intervention / Treatment
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* Drug: SGM-101


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective inclusion patients with colorectal lung metastases. Al injected with SGM-101.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SGM-101<br>Patients included with colorectal lung metastases, SGM-101 7.5-12.5mg, 3-5 days prior to surgery | Drug: SGM-101<br>* Fluorescence guided surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability of SGM-101 and a near-infrared camera system to detect colorectal lung metastases. | Intraoperative imaging of colorectal lung metastases based on the tumor-to-background ratio | peroperative |