SGM-101 in Colorectal Lung Metastases

Colorectal Cancer Clinical Trial

— SGM-CLM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04737213
• Other study ID #: P19.101
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: February 2021
• Source: Leiden University Medical Center
• Contact: Alexander Vahrmeijer
• Phone: 071 526 9111
• Email: a.l.vahrmeijer[@]lumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 and extensiveness. SGM-101 already proven to be safe and valuable in colorectal cancer. This study aims to prove feasibility for colorectal lung metastases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Metastatic Colon Cancer

Intervention

Drug:
• SGM-101
Fluorescence guided surgery

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	Zuid-Holland
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (3)

Lead Sponsor	Collaborator
Leiden University Medical Center	Erasmus Medical Center, Surgimab

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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