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SGM-101 in Colorectal Brain Metastases. (SGM-CBM)

Primary Purpose

Rectal Neoplasms, Rectum Cancer, Colorectal Neoplasms

Status
Not yet recruiting
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 treatment trial for Rectal Neoplasms

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 brain metastasis of colorectal origin and scheduled for a resection.

Exclusion Criteria:

  1. History of any anaphylactic reaction;
  2. Previous use of SGM-101;
  3. 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;

  4. 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;
  5. Patients pregnant or breastfeeding;
  6. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.

Sites / Locations

  • Leiden University Medical Center
  • Medical Center Haaglanden

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with colorectal brain metastases

Arm Description

10 mg SGM-101, administration 3 to 5 days prior to surgery.

Outcomes

Primary Outcome Measures

To determine the feasibility of SGM-101 for intraoperative imaging of colorectal brain metastases.
Concordance between the fluorescent signal and the tumor status (incl. degree of CEA-expression) of resected tissue; Concordance between the fluorescent signal and the resection margin with the use of neuronavigation

Secondary Outcome Measures

Full Information

First Posted
January 27, 2021
Last Updated
August 17, 2022
Sponsor
Leiden University Medical Center
Collaborators
Medical Center Haaglanden, Surgimab
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1. Study Identification

Unique Protocol Identification Number
NCT04755920
Brief Title
SGM-101 in Colorectal Brain Metastases.
Acronym
SGM-CBM
Official Title
A Feasibility Study of SGM-101, a Fluorochrome-labeled Anti-carcinoembryonic Antigen Monoclonal Antibody for the Intraoperative Detection of Colorectal Brain Metastases.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
This study assesses the feasibility of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody, for intraoperative near-infrared fluorescence imaging of colorectal brain metastases by injecting SGM-101 intravenously 3 - 5 days prior to surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms, Rectum Cancer, Colorectal Neoplasms, Brain Metastases, Brain Neoplasms, Brain Diseases, Brain Cancer, Brain Tumor, Intestinal Neoplasms, Gastrointestinal Neoplasms, Gastrointestinal Cancer, Gastrointestinal Disease, Intestinal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with colorectal brain metastases
Arm Type
Experimental
Arm Description
10 mg SGM-101, administration 3 to 5 days prior to surgery.
Intervention Type
Drug
Intervention Name(s)
SGM-101
Intervention Description
Fluorescence-guided surgery
Primary Outcome Measure Information:
Title
To determine the feasibility of SGM-101 for intraoperative imaging of colorectal brain metastases.
Description
Concordance between the fluorescent signal and the tumor status (incl. degree of CEA-expression) of resected tissue; Concordance between the fluorescent signal and the resection margin with the use of neuronavigation
Time Frame
Intraoperative

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 brain metastasis of colorectal origin and scheduled for a resection. Exclusion Criteria: History of any anaphylactic reaction; Previous use of SGM-101; 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; Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robin Faber, MD
Phone
+31 71 5265 401
Email
r.a.faber@lumc.nl
Facility Information:
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Vahrmeijer, MD, PhD
Facility Name
Medical Center Haaglanden
City
The Hague
ZIP/Postal Code
2512 VA
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marike Broekman, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

SGM-101 in Colorectal Brain Metastases.

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