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Trial record 3 of 4 for:    SGM-101

Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03659448
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Surgimab

Tracking Information
First Submitted Date  ICMJE May 4, 2018
First Posted Date  ICMJE September 6, 2018
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE June 17, 2019
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
Surgical resection histopathology. [ Time Frame: Through completion of surgery, up to 9 weeks. ]
Comparison of surgical resections using histopathology as standard of truth..
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
Official Title  ICMJE Multicenter, Open-label, Randomized, Controlled, Parallel Arms Clinical Study on Performance of SGM-101, a Fluorochrome-labeled Anti-CEA Monoclonal Antibody, for Delineation of Primary/Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
Brief Summary The performance of SGM-101, an intraoperative imaging agent, will be compared to that of standard "white light" visualization during surgical resections of colorectal cancer.
Detailed Description The performance of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent for the delineation of primary and recurrent tumor and metastases in patients undergoing curative surgery for colorectal cancer will be compared to that of standard "white light" visualization in a multicenter, open-label, randomized, controlled, parallel arms clinical study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Two parallel arms consisting of a treatment arm of patients who will receive the study drug and subsequently undergo surgical resections under both "standard "white light" conditions and then NIR, and a no treatment arm to whom the study drug will not be administered and who will undergo surgical resections under standard "white light" conditions only.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Colorectal Neoplasms
Intervention  ICMJE Drug: SGM-101
A fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent.
Study Arms  ICMJE
  • Active Comparator: Treatment
    Patients will receive a single dose of the study drug, SGM-101, and subsequently undergo surgical resections under both "standard "white light" conditions and then NIR.
    Intervention: Drug: SGM-101
  • No Intervention: No Treatment
    Patients will not be administered the study drug, SGM-101, and will undergo surgical resections under standard :white light" conditions only.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2018)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients should be scheduled for curative colorectal cancer surgery of primary cT4 colon cancer or primary cT3/4 rectal cancer, recurrent colorectal cancer or peritoneal metastasized colorectal cancer.
  • Female patients must be of non-child-bearing potential (i.e., women with functioning ovaries who have a documented tubal ligation or hysterectomy, ovariectomy or women who are post-menopausal). Women of child-bearing potential will be included provided that they have a negative urine pregnancy test at the day of the injection and agree to practice adequate contraception for 30 days prior to administration of investigational product, and 30 days after completion of injection.

Exclusion Criteria:

  1. Other malignancies, either currently active or diagnosed in the last 5 years, except for adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma;
  2. Primary appendiceal cancer;
  3. Laboratory abnormalities defined as:

    • Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the ULN or;
    • Total bilirubin above 2 times the ULN or;
    • 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);
  4. 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;
  5. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: John Warner, JD, MPA 8123257657 johna.warner@outlook.com
Contact: Françoise Cailler, PhD +33 467 798 381 fcailler@surgimab.com
Listed Location Countries  ICMJE Germany,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03659448
Other Study ID Numbers  ICMJE SGM-CLIN03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Surgimab
Study Sponsor  ICMJE Surgimab
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alex L. Vahrmeijer,, MD, PhD Leiden University Medical Center, Leiden, The Netherlands
PRS Account Surgimab
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP