SGM-101 in Colorectal Brain Metastases.

NCT ID: NCT04755920

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-02-28

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with colorectal brain metastases

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

Group Type: EXPERIMENTAL

SGM-101

Intervention Type: DRUG

Fluorescence-guided surgery

Interventions

SGM-101

Fluorescence-guided surgery

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Center Haaglanden

OTHER

Sponsor Role: collaborator

Surgimab

INDUSTRY

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Alexander Vahrmeijer

Oncologic Surgeon - Hepatobiliary and Colorectal

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Leiden University Medical Center

Leiden, , Netherlands

Site Status: RECRUITING

Medical Center Haaglanden

The Hague, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Mats Warmerdam, MD

Role: CONTACT

m.i.warmerdam@lumc.nl

+31 71 5265 401

Facility Contacts

Alexander Vahrmeijer, MD, PhD

Role: primary

Marike Broekman, MD, PhD

Role: primary

Other Identifiers

NL74956.058.20

Identifier Type: -

Identifier Source: org_study_id