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Study of Pre-Operative Treatments with Sotorasib and Drug Combination for Patients with Resectable 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 treatments for patients with a specific type of cancer known as colorectal cancer. This cancer affects the colon or rectum, which are parts of the large intestine. The study is designed for patients whose cancer can be surgically removed and who have certain molecular characteristics that make them suitable for targeted treatments. The purpose of the study is to evaluate the effectiveness of different short-term treatments given before surgery to see how well they work in reducing or eliminating the cancer.

The trial involves several medications, each targeting specific molecular features of the cancer. These medications include sotorasib, a selective inhibitor targeting a specific mutation in cancer cells, durvalumab, an immune therapy given through an intravenous infusion, and DS-8201a, also known as trastuzumab deruxtecan, which is another type of targeted therapy. Other medications being studied are panitumumab, Balstilimab, and botensilimab, each administered as a solution for infusion. Some patients may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments.

Participants in the study will receive one of these treatments for a short period before their scheduled surgery. The study will monitor how the cancer responds to the treatment by examining tissue samples from the tumor. The goal is to see if the treatment can lead to a complete or major reduction in the cancer before surgery. The study will also assess the safety and side effects of the treatments, as well as their impact on the patients' quality of life. This research aims to improve the understanding of how these targeted treatments can benefit patients with colorectal cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, a signed and dated informed consent document is required. This confirms understanding and agreement to participate in the trial.

    Eligibility is confirmed based on specific criteria, including age, health status, and medical history related to colorectal cancer.

  2. Step 2

    Initial assessments

    Initial assessments include a series of tests to confirm eligibility and gather baseline data. These tests may include blood tests, imaging scans, and other diagnostic procedures.

    A negative blood pregnancy test is required for women of childbearing potential.

  3. Step 3

    Treatment assignment

    Based on molecular profiling, assignment to a specific treatment cohort occurs. This involves matching the molecular characteristics of the cancer with the appropriate targeted treatment.

  4. Step 4

    Treatment administration

    The treatment phase involves receiving one or more of the following medications: durvalumab, ds-8201a, panitumumab, balstilimab, or botensilimab. These are administered as solutions for infusion, which means they are given through a vein.

    The frequency and duration of the treatment depend on the specific medication and cohort assignment. Detailed instructions will be provided by the medical team.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring occurs throughout the treatment phase. This includes laboratory tests, vital signs checks, and completion of quality-of-life questionnaires.

    Follow-up assessments are conducted to evaluate the response to treatment and any changes in health status.

  6. Step 6

    End of treatment evaluation

    At the end of the treatment phase, a comprehensive evaluation is performed. This includes imaging tests and possibly additional biopsies to assess the response of the cancer to the treatment.

    The results of these evaluations help determine the effectiveness of the treatment and inform any further medical decisions.

Who can join the trial?

16 criteria

  • Provide a signed and dated informed consent document before any study procedure.
  • Be at least 18 years old at the time of giving consent.
  • Have an ECOG PS of 0 or 1, which means you are fully active or have some symptoms but do not need bed rest during the day.
  • Have a confirmed diagnosis of colorectal adenocarcinoma that can be surgically removed with the goal of complete removal, as assessed by a team of specialists.
  • Have a specific stage of cancer as determined by a CT scan, which is a detailed imaging test.
  • If you have rectal cancer, it should be possible to remove it completely without needing radiation therapy before surgery, as assessed by a team of specialists.
  • No signs of cancer spread to other parts of the body, confirmed by a CT scan of the chest, abdomen, and pelvis.
  • Be able to provide a sufficient sample of the tumor from previous diagnostic procedures for molecular testing.
  • Have a specific molecular profile or alteration necessary for assignment to a treatment group, determined by central testing.
  • No previous systemic treatment for colorectal cancer or radiation therapy before surgery for rectal cancer.
  • Have adequate bone marrow function, which is the body's ability to produce blood cells.
  • Have adequate kidney function, with a serum creatinine level within a certain range or a calculated creatinine clearance of at least 50 mL/min.
  • Have adequate liver function, which is the body's ability to process substances.
  • If you are a woman who can become pregnant, you must have a negative blood pregnancy test at the start of the study.
  • Agree to avoid pregnancy during the trial and for a specific time after the last treatment dose, using approved contraception methods.
  • Be willing and able to attend scheduled visits, follow the treatment plan, and undergo laboratory tests and other study procedures.

Who cannot join the trial?

18 criteria

  • Patients with any other type of cancer that is not the specific type being studied.
  • Patients who have had a different cancer in the past, unless it was a type that is not likely to come back.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients who are currently receiving any other cancer treatment.
  • Patients with an active infection that requires treatment with antibiotics.
  • Patients with a known allergy to any of the drugs being used in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients with a serious heart condition.
  • Patients with uncontrolled high blood pressure.
  • Patients with a history of a bleeding disorder.
  • Patients with a history of a blood clotting disorder.
  • Patients with a history of a stroke.
  • Patients with a history of a heart attack.
  • Patients with a history of a serious lung condition.
  • Patients with a history of a serious liver condition.
  • Patients with a history of a serious kidney condition.
  • Patients with a history of a serious mental health condition.
  • Patients who are unable to follow the study procedures.
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Investigated drugs

  • UNICORN Study Medication 1

    This medication is part of a trial aimed at treating colorectal cancer before surgery. It is designed to target specific molecules in cancer cells, helping to shrink the tumor or stop its growth. This treatment is given for a short period before the surgery to see if it can improve the chances of a successful operation by reducing the size of the cancer or making it easier to remove.

  • UNICORN Study Medication 2

    This therapy is another targeted treatment used in the trial for colorectal cancer patients. It works by focusing on particular proteins or genes in the cancer cells, aiming to disrupt their growth and survival. The goal is to see if this approach can lead to a significant reduction in the tumor size or even eliminate it before the surgical procedure.

What is already known about the treatment

  • Cetuximab

    This medication is given as an infusion directly into a vein and works by blocking special signals on the surface of cancer cells that help them grow and spread. Cetuximab is already approved for the treatment of colorectal cancer and is used in combination with chemotherapy or on its own in patients whose tumors have certain genetic characteristics. The drug belongs to a group of medicines called monoclonal antibodies, which are designed to attack specific targets on cancer cells. In this study, researchers are investigating whether a short course of treatment before surgery can help shrink the tumor and improve treatment outcomes.

  • Bevacizumab

    This medication is administered as an infusion into a vein and works by preventing the formation of new blood vessels, which tumors need in order to grow and spread. Bevacizumab is already approved and routinely used for the treatment of various cancers, including colorectal cancer, often in combination with chemotherapy. It belongs to a group of drugs called angiogenesis inhibitors, which block the body's ability to form new blood vessels for tumors. In this study, researchers are testing whether a short course of treatment before surgery can help prepare the tumor for surgical removal and improve the patient's prognosis.

  • Trastuzumab

    This medication is given as an infusion into a vein and works by binding to a specific protein on the surface of certain cancer cells, which prevents them from growing and dividing. Trastuzumab is already approved for the treatment of breast cancer and stomach cancer in patients whose tumors have high levels of the HER2 protein. The drug belongs to the group of monoclonal antibodies and is designed to target cancer cells very precisely. In this study, researchers are investigating whether a short course of treatment before surgery can help patients with colorectal cancer whose tumors have genetic characteristics similar to those of the cancers in which the medicine already works.

Investigated diseases

Colorectal Cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. As the disease progresses, cancer cells can invade and destroy normal tissue nearby and may spread to other parts of the body. The progression of colorectal cancer can vary, with some cases growing slowly over several years. The disease can affect bowel habits and may cause symptoms like changes in stool consistency, blood in the stool, and abdominal discomfort.
Trial detailsLast updated 30 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501308-90-00Protocol codeUNICORNEstimated enrolment112 patientsSponsorFondazione GONO G.I.

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