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

Primary Purpose

Colorectal Cancer, Metastatic Colon Cancer

Status
Unknown status
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
SGM-101
Sponsored by
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Leiden University Medical CenterRecruiting
  • Erasmus Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SGM-101

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 27, 2021
Last Updated
February 1, 2021
Sponsor
Leiden University Medical Center
Collaborators
Erasmus Medical Center, Surgimab
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1. Study Identification

Unique Protocol Identification Number
NCT04737213
Brief Title
SGM-101 in Colorectal Lung Metastases
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
November 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
Collaborators
Erasmus Medical Center, Surgimab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Metastatic Colon Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Prospective inclusion patients with colorectal lung metastases. Al injected with SGM-101.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SGM-101
Arm Type
Experimental
Arm Description
Patients included with colorectal lung metastases, SGM-101 7.5-12.5mg, 3-5 days prior to surgery
Intervention Type
Drug
Intervention Name(s)
SGM-101
Intervention Description
Fluorescence guided surgery
Primary Outcome Measure Information:
Title
Ability of SGM-101 and a near-infrared camera system to detect colorectal lung metastases.
Description
Intraoperative imaging of colorectal lung metastases based on the tumor-to-background ratio
Time Frame
peroperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Vahrmeijer
Phone
071 526 9111
Email
a.l.vahrmeijer@lumc.nl
Facility Information:
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
Zuid-Holland
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruben Meijer, MD
Phone
+31 71 526 9111
Email
r.p.j.meijer@lumc.nl
First Name & Middle Initial & Last Name & Degree
Robin Faber
Email
r.a.faber@lumc.nl
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hidde Galema
Phone
+31 10 704 0704

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

SGM-101 in Colorectal Lung Metastases

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