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SGM-101 in Locally Advanced and Recurrent Rectal Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2/PHASE3

SGM-101 in Locally Advanced and Recurrent Rectal Cancer

Multicenter, Open-label, Controlled, Parallel Arms Clinical Study on the Performance of SGM-101, a Fluorochrome-labeled Anti-carcino-embryonic Antigen (CEA) Monoclonal Antibody, for Locally Advanced or Recurrent Rectal Cancer Patients Undergoing Curative Surgery

NCT04642924•Leiden University Medical Center

View on ClinicalTrials.gov

Summary

Near-infrared fluorescence-guided oncologic surgery (EGOS) with the use of a tumor specific tracer (SGM-101) developed by Surgimab can provide valuable intra-operative information about tumor location and extensiveness, which can be difficult to detect with conventional visual and tactile feedback. Hence, this information could aid in intra-operative decision making and therewith foster complete resection margins and less extensive surgery. Subsequently, this may drastically improve patient care by improving oncologic outcome.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients aged over 18 years old;
•2. 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.
•3. Patients should be scheduled and eligible for surgery because of a clinical diagnosis of T3 with a threatened CRM or T4 rectal cancer (locally advanced) or recurrent rectal cancer. (UICC. TNM classification of diseases for oncology. 3rd ed. Geneva: World Health Organization; 2000)
•4. Patients should be capable and willing to give signed informed consent before study specific procedures.

Exclusion Criteria

•1. Other malignancies, either currently or in the past five years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma.
•2. Patients with a history of, or recently diagnosed with, peritoneal metastases (even those diagnosed during surgery)
•3. Patients with a recent history (within the last 3 years) of other distant metastases (even those diagnosed during surgery)
•4. Patient with a history of a clinically significant allergy.
•5. Patients pregnant or breastfeeding lack of effective contraception in male or female patients with reproductive potential;
•6. 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;
+4 more criteria

Locations (4)

Amsterdam University Medical Center

Amsterdam, Netherlands

Catharina Hospital Eindhoven

Eindhoven, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

Haaglanden Medisch Centrum

The Hague, Netherlands

Key Dates

Start Date

October 22, 2019

Primary Completion Date

October 1, 2021

Completion Date

October 1, 2023

Last Updated

November 24, 2020

Enrollment

203

ESTIMATED participants

Conditions

Rectal CancerRecurrent Rectal Cancer

Interventions

SGM-101

DRUG

Contacts

Ruben Meijer

CONTACT

+31 71-52 98420 r.p.j.meijer@lumc.nl

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 24, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

SGM-101 in Locally Advanced and Recurrent Rectal Cancer

Inclusion Criteria

Exclusion Criteria

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