SGM-101 in Colorectal Lung Metastases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-12-01

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.

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Detailed Description

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Conditions

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Colorectal Cancer Metastatic Colon Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective inclusion patients with colorectal lung metastases. Al injected with SGM-101.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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SGM-101

Patients included with colorectal lung metastases, SGM-101 7.5-12.5mg, 3-5 days prior to surgery

Group Type EXPERIMENTAL

SGM-101

Intervention Type DRUG

Fluorescence guided surgery

Interventions

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SGM-101

Fluorescence guided surgery

Intervention Type DRUG

Eligibility Criteria

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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 lung metastasis of colorectal origin and scheduled for a resection.

Exclusion Criteria

1. History of any anaphylactic reaction;
2. 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;
3. 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;
4. Patients pregnant or breastfeeding (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate);
5. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
6. Previous SGM-101 use

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No