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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02973672
Recruitment Status : Completed
First Posted : November 25, 2016
Last Update Posted : July 18, 2019
Sponsor:
Collaborators:
Centre for Human Drug Research, Netherlands
Leiden University Medical Center
Erasmus Medical Center
Catharina Ziekenhuis Eindhoven
Information provided by (Responsible Party):
Surgimab

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Colon Cancer Rectum Cancer Pancreas Cancer Metastatic Colorectal Cancer Recurrent Colorectal Carcinoma Drug: SGM-101 Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : January 2016
Actual Primary Completion Date : April 15, 2019
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Tumor-to-background ratio (TBR) for fluorescence [ Time Frame: day 4 ]
  2. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973672


Locations
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Netherlands
Catharina Ziekenhuis Eindhoven
Eindhoven, Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2333 CL
Erasmus Medical Center Cancer Institute
Rotterdam, Netherlands
Sponsors and Collaborators
Surgimab
Centre for Human Drug Research, Netherlands
Leiden University Medical Center
Erasmus Medical Center
Catharina Ziekenhuis Eindhoven
Investigators
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Principal Investigator: Alexander L Vahrmeijer, MD, PhD Leiden University Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Surgimab
ClinicalTrials.gov Identifier: NCT02973672    
Other Study ID Numbers: SGM-CLIN02
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Surgimab:
Fluorescence
Surgery
Cancer
 SGM-101
Near Infrared
Immunophotodetection
Additional relevant MeSH terms:
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Colorectal Neoplasms
Pancreatic Neoplasms
Rectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases