Using SGM-101 to improve tumor visualization during colorectal cancer surgery

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

This study is testing a new imaging agent called SGM-101 to see if it can help doctors see colorectal tumors better during surgery, which might lead to better outcomes for patients.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Surgimab (Industry-sponsored)
• Locations: 11 sites (Duarte, California and 10 other locations)
• Trial ID: NCT03659448 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of SGM-101, a specialized imaging agent, in enhancing the visualization of primary and recurrent tumors as well as metastases during surgical procedures for colorectal cancer. The study compares the performance of SGM-101 against standard white light visualization in a multicenter, open-label, randomized, controlled format. Patients undergoing curative surgery for colorectal cancer will be enrolled to assess whether SGM-101 can provide better delineation of cancerous tissues, potentially leading to improved surgical outcomes.

Who should consider this trial

Good fit: Ideal candidates include patients scheduled for curative surgery for primary or recurrent colorectal cancer, particularly those with advanced stages.

Not a fit: Patients with other active malignancies or specific exclusions such as primary appendiceal cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more precise tumor removal and better surgical outcomes for colorectal cancer patients.

How similar studies have performed: Previous studies using intraoperative imaging agents have shown promise, suggesting potential for success with this novel approach.

Eligibility criteria

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.

Where this trial is running

Duarte, California and 10 other locations

• City of Hope National Medical Center — Duarte, California, United States (Recruiting)
• Moores Cancer Center - UCSD Health — La Jolla, California, United States (Recruiting)
• Cleveland Clinic Florida — Weston, Florida, United States (Recruiting)
• Massachusetts General Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
• University of Massachusetts — Worcester, Massachusetts, United States (Recruiting)
• Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States (Recruiting)
• Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und Kinderchirurgie — Göttingen, Germany (Recruiting)
• Fondazione IRCCS Policlinico San Matteo — Pavia, Lombardy, Italy (Recruiting)
• Catharina Ziekenhuis Eindhoven — Eindhoven, Netherlands (Recruiting)
• Leiden University Medical Center — Leiden, Netherlands (Recruiting)
• Erasmus MC — Rotterdam, Netherlands (Recruiting)

Study contacts

• Principal investigator: Alex L. Vahrmeijer,, MD, PhD — Leiden University Medical Center, Leiden, The Netherlands
• Study coordinator: John Warner, JD, MPA

Conditions Colorectal Neoplasms; Fluorescence; Cancer; SGM-101; Surgery; Colorectal