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

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What is this study about?

This clinical trial is focused on studying a treatment for metastatic colorectal cancer, which is a type of cancer that has spread from the colon or rectum to other parts of the body. The study involves two medications: LB-100 and azenosertib (also known as ZN-c3). LB-100 is a solution given through an infusion, which means it is administered directly into the bloodstream through a vein. Azenosertib is a tablet taken orally, meaning it is swallowed. The purpose of the study is to determine the best dose of these medications when used together in patients with metastatic colorectal cancer.

Participants in the study will receive either the combination of LB-100 and azenosertib or a placebo. The study will monitor how patients respond to the treatment over a period of time, which could last up to two years. During this time, researchers will observe the safety and tolerability of the medications, which means they will check for any side effects and how severe they are. They will also evaluate how effective the treatment is in controlling the cancer.

The trial aims to gather information on how well the combination of LB-100 and azenosertib works in treating metastatic colorectal cancer. This includes looking at how long the treatment can keep the cancer from growing, how long patients live after starting the treatment, and how long any positive effects of the treatment last. The study is an important step in finding new ways to treat this type of cancer and could lead to new treatment options for patients in the future.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

Eligibility criteria include being 18 years or older, having a specific performance status, and having advanced colorectal cancer with no curative treatment options available.

2 treatment initiation

The treatment involves a combination of two medications: LB-100 and azenosertib (also known as ZN-c3).

Azenosertib is administered in two forms: as a solution for infusion (intravenous) and as a film-coated tablet (oral).

3 medication administration

The intravenous solution is given through a vein, while the tablets are taken by mouth. The specific dosage and frequency are determined by the study protocol and adjusted based on individual response and tolerance.

4 monitoring and evaluation

Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes tracking any side effects and measuring the response of the cancer to the treatment.

The primary goal is to determine the recommended dose of the combination treatment. Secondary goals include evaluating safety, tolerability, and treatment effectiveness.

5 follow-up

Follow-up visits are scheduled to continue monitoring health status and any long-term effects of the treatment.

The study is expected to continue until December 2026, with regular assessments throughout this period.

Who Can Join the Study?

Able to understand and voluntarily sign the informed consent form. This means you agree to participate after understanding the study details.
Patient must be 18 years of age or older.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. This is a scale that measures how well you can perform daily activities. A score of 0 means you are fully active, and 1 means you have some restrictions but can still do light work.
Have a histological or cytological confirmation of advanced colorectal cancer (CRC). This means tests have confirmed the presence of cancer cells in your colon or rectum.
Patient has no curative treatment options in standard care. This should include at least a treatment plan with a drug called fluoropyrimidine, and possibly other drugs like oxaliplatin and/or irinotecan.
Presence of at least one measurable lesion defined by the Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1). This means there is a tumor that can be measured to see how it responds to treatment.

Who Cannot Join the Study?

Patients who have a different type of cancer other than metastatic colorectal cancer cannot participate. Metastatic means the cancer has spread to other parts of the body.
Patients who are younger than 18 years old or older than 65 years old are not eligible.
Patients who are part of a vulnerable population, such as those unable to give consent, are not allowed to join the study.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Netherlands Cancer Institute	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	01.06.2024

Trial locations

Investigated drugs:

LB-100 is a medication being studied for its potential to treat metastatic colorectal cancer. It works by inhibiting an enzyme called PP2A, which is involved in cell growth and division. By blocking this enzyme, LB-100 may help to slow down or stop the growth of cancer cells.

Azenosertib is another medication in the trial, which targets a protein known as WEE1. This protein plays a role in controlling the cell cycle, particularly in cancer cells. By inhibiting WEE1, azenosertib may prevent cancer cells from repairing themselves, making them more vulnerable to treatment and potentially leading to their destruction.

Investigated diseases:

Colorectal cancer metastatic

Metastatic Colorectal Cancer – This is a type of cancer that originates in the colon or rectum and has spread to other parts of the body, such as the liver or lungs. It typically begins 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 invade nearby tissues and enter the bloodstream or lymphatic system, allowing them to travel to distant organs. The spread of cancer to other parts of the body is known as metastasis. Symptoms may include changes in bowel habits, blood in the stool, abdominal pain, and unexplained weight loss. The progression and symptoms can vary depending on the location and extent of the metastasis.

Trial ID:

2024-511227-33-00

Protocol code:

N23LAC

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?