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Evaluating SGM-101 (fluorochrome-labeled antibody) in patients with locally advanced or recurrent rectal cancer undergoing surgery

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with rectal cancer that is either locally advanced or has returned after previous treatment. The study tests a new imaging method that uses a special medication called SGM-101, which is a solution given through an intravenous infusion. This medication is actually an antibody that has been modified to become visible under special lighting during surgery.

The main purpose of this research is to determine if using SGM-101 together with a special camera system called the Quest Spectrum System can help surgeons better see and remove all cancer tissue during surgery. The medication attaches to specific markers found on cancer cells, making them glow under special lighting. This could potentially help doctors ensure they remove all of the cancer during the operation.

During the study, participants will receive a single dose of SGM-101 before their planned surgery. The maximum amount given will be 15 milligrams. The surgical team will use special equipment to see the areas where the medication makes the cancer cells visible. The study will track how well this method works and follow the patients' progress for up to two years after their surgery to monitor their recovery and long-term health outcomes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medication administration

    You will receive SGM-101, a special medication designed to help identify cancer cells during surgery

    The medication will be given through an intravenous infusion (delivered directly into your vein)

  2. Step 2

    Pre-surgical period

    After receiving the medication, there will be a waiting period to allow the SGM-101 to properly distribute in your body

    During this time, your surgical procedure will be scheduled

  3. Step 3

    Surgical procedure

    The surgical team will use special imaging equipment to detect areas where the medication has attached to cancer cells

    This imaging helps guide the surgical removal of cancer tissue

    The surgical team may adjust their approach based on what they see with the imaging technology

  4. Step 4

    Post-surgical monitoring

    Your recovery will be monitored for the first 30 days after surgery

    The medical team will check for any complications during this period

  5. Step 5

    Long-term follow-up

    Your health status will be monitored for up to 2 years after the surgery

    Regular check-ups will be scheduled to track your recovery and cancer status

    You must continue using effective birth control methods for at least 30 days after receiving the study medication

Who can join the trial?

8 criteria

  • Age 18 years or older
  • Must have a clinical diagnosis of rectal cancer that is either:
    • Locally advanced (T3 cancer that threatens surrounding tissues or T4 cancer that has grown through the bowel wall), or
    • Recurrent rectal cancer (cancer that has returned after previous treatment)
    • Must be scheduled and eligible for surgery
    • Birth control requirements:
      • Women who can become pregnant must use effective birth control
      • Men must use effective birth control
      • Must continue birth control for at least 30 days after the last study treatment
      • Must be able to understand and sign an informed consent form before any study procedures begin

Who cannot join the trial?

14 criteria

  • Age below 18 years or above 65 years
  • Presence of metastatic disease (cancer that has spread to other parts of the body)
  • Previous major abdominal surgery within the last 6 months
  • Known allergies to the study medication or its components
  • Pregnancy or breastfeeding
  • Active systemic infection (infection affecting the whole body)
  • Participation in another clinical trial within the past 30 days
  • Severe heart, liver, or kidney disease
  • Uncontrolled comorbidities (other medical conditions that are not well managed)
  • Mental conditions that could interfere with following study procedures
  • History of other cancers in the past 5 years (except non-melanoma skin cancer)
  • Immunodeficiency (weakened immune system) or use of immunosuppressive medications
  • Unable to provide informed consent
  • Contraindications to surgical procedures
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Investigated drugs

SGM-101 is a specialized imaging agent that contains antibodies designed to attach to specific markers (called CEA) found on rectal cancer cells. When injected before surgery, it helps surgeons better visualize cancer tissue during the operation by making these tissues glow under special fluorescent light. This helps doctors to more precisely identify and remove cancerous tissue during surgery for patients with rectal cancer. The trial uses Fluorescence-Guided Oncologic Surgery (FGOS) combined with SGM-101 to improve the accuracy of surgical removal of rectal cancer.

What is already known about the treatment

SGM-101 – A specialized fluorescent imaging agent administered intravenously before surgery, consisting of a monoclonal antibody that targets carcinoembryonic antigen (CEA) and is labeled with a fluorescent marker. This investigational medication is currently being studied in clinical trials for its use in fluorescence-guided surgery for patients with locally advanced or recurrent rectal cancer. The compound works by binding to CEA proteins commonly found on cancer cells, making them visible to surgeons during the operation through special imaging equipment, which helps achieve more precise tumor removal. SGM-101 belongs to the class of targeted fluorescent imaging agents used for real-time surgical guidance.

Investigated diseases

Rectal Cancer - A disease that begins when cells in the rectum (the last part of the large intestine) start to grow out of control. This cancer typically develops slowly, starting as a polyp - a growth of tissue that forms on the lining of the rectum. Over time, these abnormal cells can grow into the deeper layers of the rectal wall. The cancer can affect how the body stores and eliminates waste. As the disease progresses, it can spread to nearby tissues and potentially to other parts of the body. Rectal cancer often develops in the inner lining of the rectum, known as the mucosa, before growing deeper into the rectal wall.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510768-21-00Protocol codeNL69838.056.19Estimated enrolment203 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

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