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

July 16, 2019 updated by: Surgimab

A Phase I Study Assessing the Safety and Performance of SGM-101, a Fluorochrome-labeled Anti-carcino-embryonic Antigen Monoclonal Antibody for the Detection of Neoplastic Lesions in Patients With Colorectal Cancer or Pancreatic Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Surgery is the most important therapy for patients with cancer of the colon, rectum or pancreas. Complete resection, which is a crucial factor in the prognosis of a patient, is challenging as surgeons have to rely on visual appearance and palpation to discriminate between tumor and normal tissue.

Carcinoembryonic antigen (CEA) is a tumor-specific marker that is highly expressed in a number of tumors of epithelial origin (such as colorectal carcinoma and pancreas carcinoma) while it is minimally expressed in normal adult tissues. The compound that will be studied in this research project is SGM-101, a CEA-specific chimeric antibody conjugated with a near-infrared (NIR) emitting moiety. The hypothesis is that, following preoperative iv administration of SGM-101 in patients with carcinoma of the colon, rectum or pancreas, SGM-101 will bind to CEA expressing cancer cells and these cells can then be visualized with a NIR fluorescence imaging system, thereby increasing the chance of radical resection.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis Eindhoven
      • Leiden, Netherlands, 2333 CL
        • Leiden University Medical Center
      • Rotterdam, Netherlands
        • Erasmus Medical Center Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged over 18 years old;
  • Patient should be scheduled and eligible for surgery because of a clinical diagnosis of cancer of the colon, rectum or cancer of the pancreas;
  • Both pancreatic and colorectal cancer patients: Circulating plasma CEA ≥ the upper limit of normal range (eg ≥ 3.0 ng / ml);
  • Patient suffering from recurrences and metastasis of colorectal cancer: Rising circulating plasma CEA
  • Patients should be capable and willing to give informed consent before study specific procedures.

Exclusion Criteria:

  • Anticancer therapy (e.g. chemotherapy, radiotherapy (except for routine pre-operative radiotherapy for colorectal cancer), targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion;
  • History of a clinically significant allergy;
  • Circulating plasma concentration CEA ≥ 300 ng / ml;
  • 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;
  • Patients pregnant or breastfeeding (pregnancy should be ruled out by an assay of βhCG plasma within 4±1 weeks prior to administration of the conjugate), lack of effective contraception in male or female patients with reproductive potential;
  • Laboratory abnormalities defined as:

Colorectal cancer patients only:

  • Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;
  • Total bilirubin above 2 times the Upper Limit Normal (ULN) or; Both pancreatic and colorectal cancer patients:
  • Serum creatinine above 1.5 times the ULN or;
  • Absolute neutrophils counts below 1.5 x 109/L or;
  • Platelet count below 100 x 109/L or;
  • Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);
  • 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;
  • Any condition that the investigator considers to be potentially jeopardizing the patients' wellbeing or the study objectives.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SGM-101
Drug: SGM-101
4 days before surgery, SGM-101 will be administered to the patient by intravenous injections.
Other Names:
  • SGM 101
  • SGM101

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with treatment-related adverse events
Time Frame: up to 10 days after the surgery
An Adverse Event (AE) is any untoward medical occurrence in a subject who is participating in a clinical study performed. The adverse event does not necessarily have to follow the administration of a study drug, or to have a causal relationship with the study drug. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory or vital sign finding), symptom, or disease temporally associated with the study participation, whether or not it is related to the study drug.
up to 10 days after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor-to-background ratio (TBR) for fluorescence
Time Frame: day 4
day 4
Serum SGM-101 concentrations
Time Frame: up to 1 month after surgery

Individual serum SGM-101 concentrations will be plotted versus time per individual using both a linear and log y-axis. Additionally, concentration versus time curves will be plotted per treatment group as a spaghetti plot.

Concentrations will be summarized by treatment group.
up to 1 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Surgimab

Collaborators

Erasmus Medical Center
Catharina Ziekenhuis Eindhoven
Leiden University Medical Center
Centre for Human Drug Research, Netherlands

Investigators

  • Principal Investigator: Alexander L Vahrmeijer, MD, PhD, Leiden University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

April 15, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

November 22, 2016

First Posted (Estimate)

November 25, 2016

Study Record Updates

Last Update Posted (Actual)

July 18, 2019

Last Update Submitted That Met QC Criteria

July 16, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGM-CLIN02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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