SGM-101 in Colorectal Lung Metastases

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04737213

Acronym

SGM-CLM

Enrollment

Registered

2021-02-03

Start date

2020-11-01

Completion date

2021-12-01

Last updated

2021-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Metastatic Colon Cancer

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.

Interventions

DRUGSGM-101

Fluorescence guided surgery

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Prospective inclusion patients with colorectal lung metastases. Al injected with SGM-101.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Ability of SGM-101 and a near-infrared camera system to detect colorectal lung metastases.	peroperative	Intraoperative imaging of colorectal lung metastases based on the tumor-to-background ratio

Countries

Netherlands

Contacts

Primary ContactAlexander Vahrmeijer

a.l.vahrmeijer@lumc.nl071 526 9111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026