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Study of LB-100 and Atezolizumab for Patients with Metastatic Colorectal Cancer

Registered drugNo 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 is focused on studying a type of cancer known as metastatic colorectal cancer, specifically in patients whose cancer is described as microsatellite stable. The study will explore the effects of a combination of two treatments: LB-100 and atezolizumab. LB-100 is a new type of medication that may enhance the effects of chemotherapy and immunotherapy, while atezolizumab is a medication that helps the immune system fight cancer by blocking a protein called PD-L1.

The purpose of this study is to find the best dose of LB-100 when used together with atezolizumab in patients with metastatic colorectal cancer. Participants will receive these medications through an infusion, which means the medicine is given directly into the bloodstream. The study will monitor how patients respond to the treatment over time, including any side effects they may experience. The trial will also look at how well the treatment controls the cancer and how long patients live after receiving the treatment.

Throughout the study, researchers will collect information on how the medications are processed in the body and explore certain biological markers that might help understand the treatment's effects. The study is expected to continue until 2026, with recruitment starting in 2024. This research aims to improve treatment options for patients with metastatic colorectal cancer by understanding how these medications work together.

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

    Joining the study

    Upon joining the study, participation is confirmed for individuals with microsatellite stable colorectal cancer. Eligibility is based on specific criteria, including a confirmed diagnosis and measurable disease.

    Participants must have a performance status that allows them to carry out daily activities with minimal restrictions.

  2. Step 2

    Treatment initiation

    The treatment involves a combination of two medications: LB-100 and atezolizumab. Atezolizumab is administered as a solution for infusion, specifically Tecentriq 1,200 mg, given through an intravenous infusion.

    The goal is to determine the recommended dose of LB-100 when used with atezolizumab.

  3. Step 3

    Treatment administration

    Participants receive the medications through an infusion process. The frequency and duration of administration are determined by the study protocol, focusing on safety and effectiveness.

    The study aims to find the maximum tolerated dose and monitor any side effects.

  4. Step 4

    Monitoring and evaluation

    Throughout the trial, the effectiveness of the treatment is evaluated using various measures, such as disease control rate and overall survival.

    Regular assessments include monitoring the concentration of the medications in the blood and exploring relevant biomarkers.

  5. Step 5

    Completion of the study

    The study is expected to conclude by September 2026. Participants will continue to be monitored for any long-term effects and overall outcomes.

    The final analysis will include the duration of response and any progression of the disease.

Who can join the trial?

6 criteria

  • The patient must have **colorectal cancer** that is confirmed by tests called **histological** or **cytological** tests. These tests look at cells or tissues under a microscope to check for cancer.
  • The patient must have a **measurable disease** according to specific guidelines called **Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1)**. This means the cancer can be measured in size using scans or other tests. If the patient had radiation treatment before, the cancer can only be measured if it has clearly grown since the radiation.
  • The patient must have a good general health status, which is measured by a scale called the **Eastern Cooperative Oncology Group (ECOG) performance status**. The patient should have a score of 0 or 1, meaning they are fully active or have some symptoms but do not need to stay in bed.
  • The patient can be of any gender, as both male and female patients are eligible.
  • The patient must be an adult, as the study includes age categories that typically refer to adults.
  • The patient should not be part of a vulnerable population, which means they should not be in a group that needs special protection in research, like children or people unable to give consent.

Who cannot join the trial?

4 criteria

  • Patients who do not have **microsatellite stable colorectal cancer**. This is a type of cancer in the colon or rectum that does not have a specific genetic feature called microsatellite instability.
  • Patients who are not adults. The study is only for adults, which means people who are 18 years or older.
  • Patients who are not able to receive the standard treatment with a medicine called **Atezolizumab**. This is a drug used to help the immune system fight cancer.
  • Patients who are part of a vulnerable population. This means people who might need special protection or care, like children or those unable to make decisions for themselves.
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Investigated drugs

  • LB-100

    is a medication being studied for its potential to inhibit a specific enzyme called PP2A. This enzyme is involved in various cellular processes, and by inhibiting it, LB-100 may help to enhance the effectiveness of other cancer treatments. In this trial, LB-100 is being tested in combination with another medication to see if it can improve outcomes for patients with metastatic colorectal cancer.

  • Atezolizumab

    is an immunotherapy drug that works by blocking a protein called PD-L1. This protein can prevent the immune system from attacking cancer cells. By inhibiting PD-L1, Atezolizumab helps the immune system recognize and destroy cancer cells more effectively. It is being used in this trial to treat patients with metastatic colorectal cancer, in combination with LB-100, to evaluate if the combination is more effective than standard treatments.

What is already known about the treatment

  • LB-100

    LB-100 is administered intravenously and is currently being studied in clinical trials for its potential use in treating metastatic colorectal cancer. It is not yet widely recognized in medical literature as a standard treatment. The main therapeutic indication for LB-100 is in patients with microsatellite stable colorectal cancer. At the molecular level, LB-100 works by inhibiting the enzyme PP2A, which is involved in cell growth and division. It is classified pharmacologically as a PP2A inhibitor.

  • Atezolizumab

    Atezolizumab is administered through intravenous infusion and is an established medication in the field of oncology, particularly for various types of cancer. It is used in the treatment of metastatic colorectal cancer, among other cancers. Atezolizumab functions by blocking the PD-L1 protein, which helps the immune system recognize and attack cancer cells. It is classified as a PD-L1 inhibitor.

Investigated diseases

Microsatellite Stable Colorectal Cancer – This type of colorectal cancer is characterized by the absence of microsatellite instability, meaning the DNA repair system is functioning normally. It typically progresses through the accumulation of genetic mutations that lead to uncontrolled cell growth in the colon or rectum. Patients with this condition often experience symptoms such as changes in bowel habits, blood in the stool, and abdominal discomfort. The disease can spread to other parts of the body, known as metastasis, which complicates its progression. Unlike microsatellite instability-high colorectal cancer, this type does not respond well to certain immunotherapies. The progression of the disease is monitored through various clinical parameters to assess its impact on the patient's health.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-505534-98-00Protocol codeN22CLBEstimated enrolment37 patientsSponsorHet Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

sourced from the EU Clinical Trials Register and site verification

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