MedTrace Logo

Phase I of SGM-101 in Patients With Cancer of the Colon, Rectum or Pancreas

NCT02973672 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2019-07-18

No results posted yet for this study

Summary

This study evaluates the safety and performance of SGM-101, a Carcinoembryonic Antigen (CEA)-specific chimeric antibody conjugated with a NIR emitting fluorochrome, for the visualization of CEA-expressing cancers during surgery. SGM-101 is injected 2 to 4 days before surgery and visualized using an optimized camera system.

Conditions

Interventions

DRUG

SGM-101

4 days before surgery, SGM-101 will be administered to the patient by intravenous injections.

Sponsors & Collaborators

  • Centre for Human Drug Research, Netherlands

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Catharina Ziekenhuis Eindhoven

    collaborator OTHER

  • Surgimab

    lead INDUSTRY

Principal Investigators

  • Alexander L Vahrmeijer, MD, PhD · Leiden University Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2019-04-15
Completion
2019-05-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02973672 on ClinicalTrials.gov