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Study of M9140 for Patients with Advanced Stomach Cancer

Fast replyInvestigationalNo 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 treatment for Advanced Gastric Cancer, which is a type of cancer that occurs in the stomach. The treatment being tested is a medication known as M9140, which is an Anti-CEACAM5 Antibody-Drug Conjugate. This means it is a special type of drug designed to target and attach to specific proteins on cancer cells, helping to deliver the treatment directly to the cancer. The main purpose of this study is to see how well this treatment works in patients with advanced stages of this cancer.

Participants in the study will receive the treatment M9140 through an intravenous infusion, which means the medication is given directly into a vein. The study will be conducted in multiple phases, starting with a Phase 1b/2 trial, which is designed to assess the safety and effectiveness of the treatment. The study will monitor how the cancer responds to the treatment and will also keep track of any side effects experienced by participants. The trial will continue over several years to gather comprehensive data on the treatment's impact.

Throughout the study, researchers will evaluate various outcomes, such as the number of participants who experience a reduction in cancer size, the duration of this response, and the overall control of the disease. They will also measure the time it takes for the treatment to start working and how long participants remain free from cancer progression. Additionally, the study will look at the levels of M9140 in the blood and whether participants develop any antibodies against the drug. This information will help determine the potential of M9140 as a treatment option for Advanced Gastric 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, you will be asked to sign an informed consent form. This document confirms that you understand the study and agree to participate.

    You will undergo a series of tests to ensure you meet the study's health requirements. These tests will check your blood, liver, and kidney functions, among other things.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to measure the size and extent of your cancer. This will involve imaging tests, such as CT scans, to identify measurable lesions.

  3. Step 3

    Treatment administration

    You will receive the study medication, M9140, which is an anti-CEACAM5 antibody-drug conjugate. This medication is given as an infusion directly into your vein, a process known as intravenous infusion.

    The medication is administered once every three weeks, a schedule referred to as q3w.

  4. Step 4

    Ongoing monitoring

    Throughout the study, your health will be closely monitored. This includes regular check-ups and tests to assess how your body is responding to the treatment.

    You will be asked about any side effects or changes in your condition. This helps in understanding the safety and effectiveness of the treatment.

  5. Step 5

    Response evaluation

    Your response to the treatment will be evaluated using specific criteria to measure any changes in your cancer. This involves regular imaging tests to track the size of your tumors.

    The study aims to determine the objective response to the treatment, which refers to the reduction in tumor size.

  6. Step 6

    Completion of participation

    Once your participation in the study is complete, a final assessment will be conducted. This will include a review of your overall health and any changes in your condition.

    You will receive guidance on the next steps for your care and any follow-up treatments that may be necessary.

Who can join the trial?

11 criteria

  • Participants must be able to sign an informed consent form, which means they understand the study and agree to take part.
  • Participants should have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. This is a scale used to assess how a disease affects a patient's daily living abilities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Participants must have proper blood, liver, and kidney function as defined in the study protocol.
  • Participants must have at least one tumor that can be measured using a method called RECIST v1.1, which is a set of rules to measure how tumors respond to treatment.
  • Participants in Part A and Part B must have a confirmed diagnosis of advanced or metastatic, HER2 negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. This means the cancer has spread and does not have a protein called HER2 on its surface.
  • Participants must have been intolerant to, or their cancer must have worsened after, previous treatments for advanced or metastatic cancer.
  • Participants must have received and their cancer must have worsened after at least one but no more than two previous treatments for advanced or metastatic disease.
  • Participants in Part A must have CEACAM5high gastric or GEJ cancer, which means a high level of a specific protein in at least 50% of tumor cells.
  • Participants in Part B must have CEACAM5low gastric or GEJ cancer, which means a lower level of a specific protein in less than 50% of tumor cells.
  • Participants can be of any gender.
  • The study includes vulnerable populations, which may include groups like children, pregnant women, or others who might need special considerations.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer other than Gastric Cancer cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are not able to follow the study procedures cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had a recent major surgery or injury cannot participate.
  • Patients who have a known allergy to the study medication cannot participate.
  • Patients who have a history of substance abuse cannot participate.
  • Patients who have an infection that requires treatment cannot participate.
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Investigated drugs

M9140 is a special type of treatment called an antibody-drug conjugate. This means it combines an antibody, which is a protein that can find and attach to specific targets in the body, with a drug that can kill cancer cells. In this study, M9140 is designed to find and attach to a protein called CEACAM5, which is often found on the surface of certain cancer cells, like those in advanced gastric cancer. Once M9140 attaches to the cancer cells, it delivers the drug directly to them, helping to destroy the cancer cells while trying to limit damage to healthy cells. This treatment is being tested to see how well it works on its own in people with advanced gastric cancer.

What is already known about the treatment

M9140 – M9140 is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. This medication is currently being studied in clinical trials for its effectiveness in treating advanced gastric cancer. It works by targeting a specific protein on cancer cells, delivering a toxic substance directly to these cells to help destroy them. M9140 is classified as an antibody-drug conjugate, a type of targeted cancer therapy designed to minimize damage to healthy cells while attacking cancer cells.

Investigated diseases

Gastric Cancer – Gastric cancer, also known as stomach cancer, begins in the cells lining the stomach. It typically starts in the mucosa, the innermost layer of the stomach, and can grow deeper into the stomach wall. As the disease progresses, it may spread to nearby lymph nodes and other organs such as the liver, pancreas, and esophagus. The cancer can also metastasize through the bloodstream to distant parts of the body. Symptoms often include indigestion, stomach pain, nausea, and weight loss. The progression of gastric cancer can vary, with some cases advancing more rapidly than others.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517817-34-00Protocol codeMS202329_0010Estimated enrolment91 patientsSponsorMerck Healthcare KGaA

sourced from the EU Clinical Trials Register and site verification

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