Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)

This research study, called PROCEADE PanTumor, is testing a new medicine called M9140. It's for adults with advanced stomach, lung (non-small cell), or pancreatic cancer that has spread. The study wants to find out if M9140 is safe and if it helps shrink these cancers, especially those that have a specific marker called CEACAM5. This marker is like a flag on the cancer cells that the medicine is designed to target. The study is divided into different parts, or 'substudies,' for each cancer type, and it's looking at whether the medicine works on its own or with other treatments. It's a key step in understanding if M9140 could be a future treatment option.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

EMD Serono Research & Development Institute, Inc.

Enrolment target

250

Start

29 Jan 2025

Estimated completion

23 Dec 2027

Solid Tumors Gastric Cancer Non-Small Cell Lung Cancer (NSCLC)Pancreatic Cancer Pancreatic Ductal Adenocarcinoma (PDAC)

What is this study about?

This study, called PROCEADE PanTumor, is examining a new treatment named M9140. This medicine is designed to work as an 'antibody-drug conjugate,' which means it's like a guided missile. It has an antibody that finds a specific protein, called CEACAM5, which is often found on certain cancer cells. Once it finds the cancer cell, it delivers a cancer-fighting drug directly to it, aiming to cause less harm to healthy cells. The study wants to see how well M9140 fights different types of advanced cancers – specifically stomach, non-small cell lung cancer, and pancreatic cancer – that have this CEACAM5 marker.

The main goal is to understand if M9140 is safe for patients and how well their bodies tolerate it. Researchers will also be looking to see if the medicine helps to shrink or control the cancer. The study is designed to be flexible, with different 'substudies' focusing on each specific cancer type. This allows the researchers to gather detailed information for each type of cancer, making sure the M9140 treatment is carefully studied.

This is a 'Phase 1b/2' study, meaning it's still in the earlier stages of research. Phase 1b focuses on finding the right dose and checking for safety, while Phase 2 starts to look more closely at how well the treatment works. This research is important because it could lead to new treatment options for people with these advanced cancers. Finding treatments that specifically target cancer cells, like M9140 aims to do, can be a promising approach.

Key takeaways

Tests a new medicine, M9140, for advanced stomach, lung, and pancreatic cancers.
M9140 targets a specific marker (CEACAM5) on cancer cells.
Aims to check safety and how well the treatment works.
Involves regular hospital visits for infusions and check-ups.
Participation length varies, generally 8-12 months.
Patients can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult aged 18 or older. An important part of joining is understanding and signing a consent form. Generally, you need to be strong enough to take part and have certain blood test results within a healthy range, as checked by the study doctors. Your cancer also needs to have a measurable spot that doctors can track.

For specific substudies: If you have advanced stomach cancer, your cancer must have progressed after certain previous treatments, and your cancer cells need to show the CEACAM5 marker. Similarly, if you have advanced non-small cell lung cancer or pancreatic cancer, you must have tried and progressed on other treatments, and your cancer cells also need to show the CEACAM5 marker. The study will check for this marker during screening.

It's important to remember that these are just some of the main requirements. The study doctors will carefully review your full medical history to see if this study is suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced stomach, non-small cell lung, or pancreatic cancer that has progressed after previous treatments?
Are you generally well enough to participate in a study, as assessed by a doctor?
Is your cancer measurable by scans?
Are you willing and able to understand and sign an informed consent form?
Are you prepared for regular hospital visits for treatment and monitoring?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step is a 'screening period' lasting about 28 days. During this time, you'll have tests to see if you meet all the study's requirements. If you're eligible, you'll receive the study medicine, M9140, through a drip (infusion) into your vein. Each infusion usually takes about an hour and happens on the first day of each treatment cycle. The length of time you'll be in the study varies depending on your cancer type: on average, it's about 10 months for stomach cancer, 12 months for lung cancer, and 8 months for pancreatic cancer.

Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working. After your last dose of M9140, there will be a follow-up visit about a month later to check on your safety. You'll be closely monitored by the study team, who will be available to answer any questions and address any side effects you might experience.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. The potential benefit of this study is that M9140 might help control or shrink your cancer, and you would be among the first to receive this new medicine. However, because this is an investigational drug, there are also potential risks and side effects that are not yet fully known. These will be discussed in detail by the study team, and you will be closely monitored for any reactions. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (81)

University of California - Los Angeles - 300208353
Verified postcode
Santa Monica, United States
Providence Medical Foundation
Verified postcode
Santa Rosa, United States
Georgetown University - Lombardi Comprehensive Cancer Center - 1134847
Verified postcode
Washington D.C., United States
D&H Cancer Research Center
Verified postcode
Margate, United States
Prisma Health Cancer Institute, ITOR, CRU
Verified postcode
Greenville, United States
Baptist Cancer Center
Verified postcode
Memphis, United States
The University of Texas MD Anderson Cancer Center
Verified postcode
Houston, United States
NEXT Virginia
Verified postcode
Fairfax, United States
Flinders Medical Centre
Verified postcode
Bedford Park, Australia
Nepean Cancer Care Centre
Verified postcode
Kingswood, Australia
Mater Misericordiae Ltd - PARENT
Verified postcode
South Brisbane, Australia
Macquarie University Hospital - PARENT
Verified postcode
Sydney, Australia

Common questions

What is CEACAM5?

CEACAM5 is a protein found on the surface of some cancer cells. The study medicine, M9140, is designed to specifically target these cells.

What does 'advanced solid tumor' mean?

It means the cancer has grown into surrounding tissues or has spread to other parts of the body. 'Solid tumor' refers to an abnormal mass of tissue, like those found in stomach, lung, or pancreatic cancer.

Will I get M9140 or a placebo?

This study does not use a placebo. All participants who are accepted into the study will receive the active treatment, M9140, either on its own or with other medicines.

How long will I be on the treatment?

The treatment duration can vary. The overall study participation, including the initial screening and follow-up, can range from about 8 to 12 months, depending on which cancer type is being studied.

What are the common side effects of M9140?

Since M9140 is a new medicine, all possible side effects are not yet fully known. The study team will provide you with all available information on known side effects and closely monitor you for any reactions during the trial.