Study of M9140 for Patients with Advanced Stomach Cancer

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Centr Georges Francois Leclerc	Dijon	France
Technische Universitaet Dresden	Dresden	Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Medical University Of Vienna	Vienna	Austria
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Universitaet Leipzig	Leipzig	Germany

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Istituto Oncologico Veneto	Padua	Italy
Hopital Saint Antoine	Paris	France
Hospital Foch	Suresnes	France
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
SCRI CCCIT Ges.m.b.H.	Salzburg	Austria
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Universita’ Di Pisa	Pisa	Italy
Universita’ Politecnica Delle Marche	Ancona	Italy
Hospital Hm Nou Delfos	Barcelona	Spain
Hopital Beaujon	Clichy	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Imtdrv Itfpohkb Fbvfwvcyotiiz Ogysffolyda	Rome	Italy
Inueonjm Ckcval Dusbjaaqzukhofywb	L'hospitalet De Llobregat	Spain
Ahrticp Ute Issii Di Rpltlr Epskpl	Reggio Emilia	Italy
Hfyqllet Uglcbuaxpcwxv Hqbclleo Tgvga y Ptiyps Itizxpjz Cqbuts dldlvvpdlyfblirzc (qjzd	Badalona	Spain
Hpbjufqh Vqlt dyjjzrjw	Barcelona	Spain
Cjbhdw Ofsrp Ljpmamb	Lille	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	20.04.2025
France	Not recruiting	20.04.2025
Germany	Not recruiting	20.04.2025
Italy	Not recruiting	20.04.2025
Spain	Not recruiting	20.04.2025

Trial locations

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.

Investigated diseases:

Metastatic gastric cancer

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 ID:

2024-517817-34-00

Protocol code:

MS202329_0010

NCT ID:

NCT06710132

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of M9140 for Patients with Advanced Stomach Cancer

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