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Study Comparing Sacituzumab Govitecan with Standard Treatment for Patients with Metastatic Colorectal Cancer

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What is this trial about?

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

This clinical trial is focused on studying a treatment for Metastatic Colorectal Cancer, a type of cancer that has spread from the colon or rectum to other parts of the body. The trial is investigating the effectiveness of a medication called Sacituzumab Govitecan, which is a type of drug known as an antibody-drug conjugate. This means it combines an antibody, which can specifically target cancer cells, with a drug that can kill these cells. The study aims to see how well this treatment works compared to the standard treatments currently used for this type of cancer.

Participants in the study will receive either Sacituzumab Govitecan or a standard treatment chosen by their doctor. The study will be conducted in two parts. In the first part, all participants will receive Sacituzumab Govitecan to see how effective it is in stopping the cancer from getting worse. If the results are promising, the second part will compare Sacituzumab Govitecan directly with standard treatments to see which is better. The study will last for up to 24 months, and participants will be monitored regularly to assess the progress of their cancer and any side effects they may experience.

Other medications involved in the study include Regorafenib, Trifluridine combined with Tipiracil, and Bevacizumab. These are standard treatments for colorectal cancer and will be used as comparisons in the study. The goal is to determine if Sacituzumab Govitecan can provide better outcomes for patients with metastatic colorectal cancer. Participants will be closely monitored throughout the study to ensure their safety and to gather information on how well the treatments are working.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, eligibility is confirmed based on specific criteria such as age, diagnosis of metastatic colorectal cancer, and previous treatment history.

    A comprehensive assessment is conducted to ensure all criteria are met, including a review of medical history and current health status.

  2. Step 2

    Initial assessment

    An initial assessment involves imaging tests like computed tomography (CT) or magnetic resonance imaging (MRI) to identify measurable lesions.

    These tests help establish a baseline for monitoring the disease's progression throughout the trial.

  3. Step 3

    Treatment phase part I

    The first part of the trial involves treatment with sacituzumab govitecan, an antibody-drug conjugate targeting TROP2.

    The treatment is administered through infusion, and its effectiveness is measured by progression-free survival, which is the time until the disease progresses or any cause of death occurs.

  4. Step 4

    Evaluation of efficacy

    The effectiveness of the treatment is evaluated based on progression-free survival.

    If the treatment shows high clinical efficacy, the trial progresses to the next phase.

  5. Step 5

    Treatment phase part II

    In the second part of the trial, participants are randomly assigned to receive either sacituzumab govitecan or the standard of care, which is determined by the physician's choice.

    The goal is to compare the effectiveness of sacituzumab govitecan against standard treatments.

  6. Step 6

    Ongoing monitoring

    Throughout the trial, regular monitoring is conducted to assess overall survival, response rate, disease control rate, and duration of response.

    These assessments help determine the treatment's impact on the disease and overall health.

  7. Step 7

    Completion of trial

    The trial is estimated to conclude by August 2028.

    Final assessments are conducted to evaluate the long-term effects and overall success of the treatment.

Who can join the trial?

6 criteria

  • Must have a diagnosis of **Stage IV Metastatic Colorectal Cancer (mCRC)**, which means the cancer has spread to other parts of the body and cannot be treated with local therapies like surgery.
  • Must be a **woman or man aged 18 years or older**. There is no upper age limit.
  • Must have an **ECOG performance status of 2 or less**. This is a scale that measures how well a person can perform daily activities. A score of 2 means the person is up and about more than half the day and can take care of themselves but cannot work.
  • Must have tried standard cancer treatments and either did not respond to them or could not tolerate them. These treatments include **fluoropyrimidine, oxaliplatin, and irinotecan**. Previous treatments with targeted therapies, such as certain antibodies or proteins, are allowed.
  • Must not have received **Irinotecan** treatment in the last 6 months. If they had Irinotecan treatment more than 6 months ago, they must have responded well to it, meaning the cancer either shrank or stayed the same for at least 3 months.
  • Must have at least one **measurable lesion**. This means there is a tumor that can be seen and measured using imaging tests like a CT scan or MRI. The scan should be recent, not older than 30 days before starting the trial treatment.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer other than Metastatic Colorectal Cancer (mCRC) cannot participate. Metastatic means the cancer has spread to other parts of the body.
  • Individuals who are not within the specified age range for the study are excluded. The study is open to certain age groups only.
  • Participants who are part of a vulnerable population, which means they might need special protection or care, are not eligible.
  • Both men and women can participate, so gender is not a reason for exclusion.
  • There are no specific medical conditions listed that would exclude someone from participating, other than having a different type of cancer.
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Investigated drugs

Sacituzumab Govitecan is an antibody-drug conjugate used in this trial to treat patients with metastatic colorectal cancer. It targets a protein called TROP2, which is often found in high levels on cancer cells. The medication works by delivering a powerful anti-cancer drug directly to the cancer cells, helping to stop their growth and spread. This trial aims to determine how effective Sacituzumab Govitecan is in improving the survival of patients compared to other standard treatments.

What is already known about the treatment

Sacituzumab Govitecan – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic colorectal cancer. It is an antibody-drug conjugate that targets the TROP2 protein, which is often found in high levels on cancer cells. By binding to TROP2, Sacituzumab Govitecan delivers a chemotherapy agent directly to the cancer cells, helping to destroy them while minimizing damage to normal cells. It is classified as an antineoplastic agent, specifically designed to target and kill cancer cells.

Investigated diseases

Metastatic Colorectal Cancer – This is a type of cancer that begins in the colon or rectum and has spread to other parts of the body, such as the liver or lungs. It often starts as a growth, called a polyp, on the inner lining of the colon or rectum, which can become cancerous over time. As the disease progresses, cancer cells can break away from the original tumor and travel through the blood or lymphatic system to form new tumors in other organs. The progression of metastatic colorectal cancer can vary, with some tumors growing slowly and others more rapidly. Symptoms may include changes in bowel habits, blood in the stool, abdominal pain, and unexplained weight loss. The disease is typically diagnosed through a combination of imaging tests, biopsies, and blood tests.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-509771-17-00Protocol codeNCT_GI_BCK_01Estimated enrolment80 patientsSponsorUniversitaetsklinikum Heidelberg AöR

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