SGM-101 in Colorectal Lung Metastases (SGM-CLM)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Metastatic Colon Cancer
• Intervention / Treatment: Drug: SGM-101

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alexander Vahrmeijer; Phone Number: 071 526 9111; Email: a.l.vahrmeijer@lumc.nl

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Not yet recruiting
    • Erasmus Medical Center
    • Contact: Hidde Galema; Phone Number: +31 10 704 0704
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands, 2333 ZA
      • Recruiting
      • Leiden University Medical Center
      • Contact: Ruben Meijer, MD; Phone Number: +31 71 526 9111; Email: r.p.j.meijer@lumc.nl
      • Contact: Robin Faber; Email: r.a.faber@lumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Collaborators: Erasmus Medical Center; Surgimab

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: P19.101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No