CClinicalTrials.gg
Status unknownNCT04737213SGM-CLMUpdated Feb 3, 2021

SGM-101 in Colorectal Lung Metastases

A Phase 2 interventional study of SGM-101 in Colorectal Cancer and Metastatic Colon Cancer, sponsored by Leiden University Medical Center. Status unknown at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-03.

Sponsored by Leiden University Medical Center · Phase 2, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Cancer
  • Metastatic Colon Cancer
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 10 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Leiden University Medical Center is the lead sponsor of 326 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    SGM-101

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

    Drug: SGM-101

Interventions

  • DrugSGM-101

    Fluorescence guided surgery

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: peroperative

07

Study locations

1 of 2 sites recruiting
  • Leiden University Medical Center
    Leiden, Zuid-Holland 2333 ZA, Netherlands
    Recruiting
  • Erasmus Medical Center
    Rotterdam, Netherlands
    • Hidde Galema · Contact · +31 10 704 0704
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04737213
Lead sponsor
Leiden University Medical Center
Collaborators
Erasmus Medical Center, Surgimab
Responsible party
Alexander Vahrmeijer (Principal Investigator, Leiden University Medical Center) — Principal investigator
First posted
Feb 3, 2021
Start date
Nov 1, 2020
Primary completion
Nov 1, 2021 (estimated)
Completion
Dec 1, 2021 (estimated)
Last update
Feb 3, 2021

Study contacts

Alexander Vahrmeijer
Contact
a.l.vahrmeijer@lumc.nl
071 526 9111

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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