Not yet recruitingRare disease

Study of M9140 for Patients With Advanced Pancreatic 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 type of cancer called Pancreatic Ductal Adenocarcinoma, which is a common form of pancreatic cancer. The study is testing a new treatment called M9140, which is an Anti-CEACAM5 Antibody-Drug Conjugate. This means it is a special type of medicine that combines an antibody, which can target specific cancer cells, with a drug that can help kill these cells. The goal of the study is to see how well this treatment works in people with advanced pancreatic cancer.

Participants in the study will receive the treatment M9140 through an intravenous infusion, which means it will be given directly into a vein. The study will observe how the cancer responds to the treatment and will also monitor any side effects that participants might experience. The study is designed to understand the treatment's effectiveness and safety over a period of time.

The trial will help determine the clinical activity of M9140 by measuring the objective response, which refers to how much the cancer shrinks or disappears after treatment. Other aspects being studied include the duration of response, progression-free survival, and any adverse events related to the treatment. This research aims to provide valuable information about the potential benefits of M9140 for people with advanced pancreatic cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

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 screening process to ensure you meet the study's eligibility criteria. This includes tests to check your overall health and specific tests to confirm the presence of a high level of a protein called CEACAM5 in your tumor.
Step 2
Treatment initiation
Once eligibility is confirmed, you will begin treatment with the study medication, M9140. This medication is administered as a powder mixed into a solution and given through an intravenous infusion, which means it is delivered directly into your bloodstream through a vein.
The treatment is given once every three weeks, a schedule referred to as q3w.
Step 3
Ongoing treatment and monitoring
Throughout the study, you will continue to receive the M9140 treatment every three weeks. Regular visits to the study site will be necessary for these infusions.
During these visits, your health will be closely monitored. This includes regular blood tests and imaging tests to assess how your cancer is responding to the treatment.
Step 4
Assessment of response
The main goal of the study is to evaluate the objective response to the treatment, which means measuring how much the cancer shrinks or disappears after treatment.
Secondary assessments include monitoring for any side effects, the duration of response, and overall disease control.
Step 5
Completion of study participation
Your participation in the study will continue until the study ends or until it is determined that the treatment is no longer beneficial for you.
Upon completion, you will have a final visit where your overall health and response to the treatment will be evaluated.

Who can join the trial?

9 criteria

Participants must be able to sign a document that shows they understand the study and agree to take part.
Participants should have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status scale, which measures how well they can perform daily activities.
Participants need to have normal blood, liver, and kidney function as defined in the study guidelines.
Participants must have at least one tumor that can be measured using a standard method called RECIST v1.1.
Participants should have advanced or metastatic Pancreatic Ductal Adenocarcinoma (PDAC) confirmed by a tissue sample, and they must have not responded to or cannot tolerate previous treatments for advanced or metastatic cancer.
Participants must have tried at least one but no more than two different treatments for advanced or metastatic cancer and shown progression of the disease according to RECIST v1.1.
All participants will be tested to check the level of a protein called CEACAM5 in their tumors. Only those with high levels of this protein will be eligible.
Participants can be of any gender.
The study includes vulnerable populations, which means it considers people who might need special protection or care.

Who cannot join the trial?

8 criteria

Patients with other types of cancer besides Pancreatic Ductal Adenocarcinoma 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 with severe uncontrolled medical conditions cannot participate.
Patients who have had another cancer treatment recently cannot participate.
Patients with known allergies to the study medication cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Universitario Hm Sanchinarro
Responsive
Madrid, Spain
Istituto Oncologico Veneto
Responsive
Padua, Italy
Katholisches Klinikum Bochum gGmbH
Responsive
Bochum, Germany

Trial locations

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Investigated drugs

M9140 is a special type of treatment called an antibody-drug conjugate. This means it combines two parts: an antibody and a drug. The antibody part helps the treatment find and attach to specific cancer cells, in this case, those related to advanced pancreatic cancer. Once attached, the drug part is released to help kill the cancer cells. This treatment is being studied to see how well it works on its own in patients with advanced pancreatic cancer. The goal is to see if it can help reduce the size of the cancer or slow its growth.

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. It is currently being studied in clinical trials for its effectiveness in treating advanced pancreatic cancer, specifically Pancreatic Ductal Adenocarcinoma. The main goal of this medication is to assess its ability to shrink tumors in patients. M9140 works by targeting a specific protein found on cancer cells, known as CEACAM5, and delivering a toxic substance directly to these cells to kill them. It is classified as an antibody-drug conjugate, which is a type of targeted cancer therapy.

Investigated diseases

Pancreatic Ductal Adenocarcinoma – This is a type of cancer that begins in the ducts of the pancreas, which is an organ located behind the stomach. It typically starts when cells in the pancreatic ducts develop mutations in their DNA, causing them to grow uncontrollably. As the disease progresses, these cancerous cells can form a tumor that may invade nearby tissues and organs. Over time, the cancer can spread to other parts of the body through the lymphatic system or bloodstream. The progression of the disease can lead to symptoms such as jaundice, weight loss, and abdominal pain. The growth and spread of the tumor can affect the pancreas's ability to function properly, impacting digestion and blood sugar regulation.