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A Study of Raludotatug Deruxtecan for People with Gastrointestinal Cancers to Evaluate Safety and Effectiveness

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at people with gastrointestinal cancers, which are cancers that affect the digestive system. The types of cancer included in this study are pancreatic ductal adenocarcinoma, which is a cancer of the pancreas, cholangiocarcinoma, which is cancer of the bile ducts, gallbladder cancer, colorectal adenocarcinoma, which is cancer of the colon or rectum, gastric adenocarcinoma, which is stomach cancer, gastroesophageal junction adenocarcinoma, which is cancer where the stomach meets the esophagus, and esophageal adenocarcinoma, which is cancer of the esophagus. These cancers must be unresectable, meaning they cannot be removed by surgery, or metastatic, meaning they have spread to other parts of the body. The treatment being studied is called Raludotatug Deruxtecan, which is also known by the code name MK-5909. This medication is given through an intravenous infusion, which means it is delivered directly into a vein.

The purpose of this study is to evaluate how safe and effective Raludotatug Deruxtecan is in treating these types of gastrointestinal cancers. The study will look at whether the treatment helps to shrink the tumors and how long any improvement lasts. The study will also collect information about any side effects or unwanted reactions that people may experience while receiving the treatment. People taking part in this study will have already received previous treatment for their cancer before joining.

During the study, participants will receive the study medication for up to 12 months. Doctors will monitor how the cancer responds to the treatment and will check for any side effects. The study will measure things like whether the tumors get smaller, how long the treatment works, how long people live without their cancer getting worse, and overall survival. This is an open-label study, which means that both the doctors and the participants will know what treatment is being given.

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
Treatment Administration
Your treatment will involve receiving raludotatug deruxtecan, which is the medication being studied in this clinical trial.
The medication will be given to you through intravenous infusion, which means it will be delivered directly into your vein through a needle or catheter.
The medication is provided as a solution for infusion, prepared specifically for administration into your bloodstream.
Step 2
Monitoring and Assessments
During the study, your response to treatment will be assessed using RECIST 1.1 criteria, which is a standard method for measuring how tumors respond to treatment by evaluating changes in tumor size.
These assessments will be performed by an independent committee of medical experts called BICR (Blinded Independent Central Review) to ensure objective evaluation of your treatment response.
Your doctors will monitor you for any adverse events, which are any unwanted or harmful effects that may occur during treatment.
Step 3
Safety Monitoring
Throughout the study, your safety will be closely monitored by tracking any side effects or health changes you experience.
If you experience adverse events that are concerning, your treatment may be adjusted or discontinued depending on the severity and nature of the effects.
Regular safety assessments will be conducted to ensure your wellbeing during participation in the study.
Step 4
Response Evaluation
The primary goal of the study is to evaluate the objective response rate, which measures the percentage of patients whose tumors shrink or disappear after treatment.
Additional measurements will include duration of response, which tracks how long your tumor remains reduced in size after responding to treatment.
Progression-free survival will be measured, which is the length of time during and after treatment that your cancer does not grow or spread.
Overall survival will also be tracked, which measures the length of time you remain alive after starting treatment.
Step 5
Study Duration
The clinical trial is expected to continue until April 2026.
Your individual participation duration will depend on how you respond to treatment and whether you experience any adverse events that require discontinuation.
You will continue to be followed and monitored according to the study protocol throughout your participation period.

Who can join the trial?

5 criteria

You must have one of the following types of cancer that cannot be removed by surgery or has spread to other parts of the body: cancer of the pancreas (a gland behind the stomach that helps with digestion), cancer of the biliary tract (tubes that carry bile from the liver, including cancers inside or outside the liver or in the gallbladder), cancer of the colon or rectum (parts of the large intestine), or cancer of the stomach, the area where the stomach meets the esophagus, or the esophagus (the tube that connects your mouth to your stomach)
You must have already received treatment for your cancer before joining this study
Your doctor expects that you will live for at least 3 months
You must be an adult, aged 18 years or older
Both men and women can participate in this study

Who cannot join the trial?

4 criteria

The study does not provide specific exclusion criteria information in the available data
Please note that this clinical trial is designed for patients with gastrointestinal cancers, which are cancers affecting the digestive system including organs like the stomach, intestines, colon, liver, and pancreas
The trial accepts both male and female patients
The trial includes adult and elderly patients based on the age categories indicated

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Verified sites

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Centre Francois Baclesse
Caen, France
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Hopital Beaujon
Clichy, France
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Hospital Clinic De Barcelona
Barcelona, Spain

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Investigated drugs

Raludotatug Deruxtecan is an investigational medication being studied for the treatment of gastrointestinal cancers. This is an experimental drug that is being tested to see if it is safe and effective in treating cancers that affect the digestive system, which includes organs like the stomach, intestines, and other parts of the digestive tract. The study will look at whether this medication can help shrink tumors and how well patients tolerate it.

Raludotatug Deruxtecan

What is already known about the treatment

Raludotatug Deruxtecan – This is an experimental cancer medication currently being studied in clinical trials for the treatment of gastrointestinal cancers, which means it has not yet received full approval for regular medical use. The drug is administered through injection into a vein and works by targeting specific proteins on cancer cells, delivering a powerful chemotherapy agent directly to the tumor while minimizing damage to healthy tissues. It belongs to a class of medications called antibody-drug conjugates, which combine targeted therapy with chemotherapy to attack cancer cells more precisely. The medication is being tested to determine how well it works in shrinking tumors and how safe it is for patients with cancers of the digestive system.

Investigated diseases

Gastrointestinal Cancers – Gastrointestinal cancers are malignant tumors that develop in the digestive system, which includes organs such as the esophagus, stomach, liver, pancreas, gallbladder, small intestine, colon, and rectum. These cancers begin when abnormal cells in the gastrointestinal tract start to grow uncontrollably, forming tumors that can interfere with normal digestive functions. The disease typically starts in the inner lining of the affected organ and may gradually spread deeper into the organ walls. As the cancer progresses, it can grow larger and potentially spread to nearby lymph nodes and tissues. Different types of gastrointestinal cancers progress at varying rates depending on the specific organ affected and the characteristics of the cancer cells. Symptoms often develop gradually and may include changes in bowel habits, abdominal pain, unexplained weight loss, difficulty swallowing, or blood in the stool, depending on which part of the digestive system is affected.