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Study on the Safety and Effectiveness of Patritumab Deruxtecan for Patients with Colorectal, Biliary Tract, and Liver Cancer

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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 certain types of gastrointestinal cancers, specifically colorectal cancer, biliary tract cancer, and hepatocellular carcinoma. The treatment being tested is called patritumab deruxtecan, also known by its code name MK-1022. This medication is a special type of drug known as a monoclonal antibody, which is designed to target specific proteins in cancer cells. The purpose of the study is to evaluate the safety and effectiveness of this treatment in people with these types of cancers.

Participants in the study will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor how well the treatment is tolerated and its impact on the cancer. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects. The study will also look at how the cancer responds to the treatment, including how long any positive effects last and whether the cancer progresses or not.

Throughout the study, researchers will collect information on any side effects experienced by participants and how the treatment affects their overall health. The study aims to provide valuable insights into the potential benefits and risks of using patritumab deruxtecan for treating these specific types of gastrointestinal cancers. The results will help determine if this treatment could be a viable option for patients in the future.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.
Eligibility criteria include having specific types of gastrointestinal cancers such as colorectal carcinoma, biliary tract carcinoma, or hepatocellular carcinoma.
Participants must have a performance status of 0 to 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory.
Step 2
Treatment initiation
The treatment involves the administration of patritumab deruxtecan through an intravenous infusion. This is a solution specifically prepared for infusion.
The dosage and frequency of the infusion are determined based on the study protocol and individual patient needs.
Step 3
Monitoring and evaluation
Regular monitoring is conducted to evaluate the safety and tolerability of the treatment. This includes checking for any dose-limiting toxicities and adverse events.
Participants are assessed for their response to the treatment, including measuring the objective response rate, which indicates the proportion of patients with tumor size reduction.
Step 4
Follow-up assessments
Follow-up assessments are scheduled to measure the duration of response, progression-free survival, and overall survival.
Blood samples may be taken to determine the maximum and trough concentrations of patritumab deruxtecan in the plasma.
Step 5
Completion of study
The study is estimated to conclude by July 2028. Participants will be informed about the outcomes and any further steps if necessary.

Who can join the trial?

13 criteria

Participants must have one of the following cancers: **Colorectal Carcinoma**, **Biliary Tract Carcinoma**, or **Hepatocellular Carcinoma**.
Participants who are positive for **Hepatitis B surface antigen (HBsAg)** can join if they have been on **Hepatitis B virus (HBV)** antiviral treatment for at least 4 weeks and have no detectable HBV virus in their blood.
Participants with a history of **Hepatitis C virus (HCV)** infection can join if the virus is not detectable in their blood.
Participants must have an **Eastern Cooperative Oncology Group performance status (ECOG PS)** of 0 to 1, which means they are fully active or have some symptoms but can still do light work.
For those with **second line hepatocellular carcinoma**: They must have received only one previous treatment with a specific type of cancer therapy called **anti-PD-1/PD-L1**.
For those with **second line colorectal cancer**: They must have a confirmed diagnosis of colorectal cancer that cannot be removed by surgery or has spread to other parts of the body.
For those with **second line colorectal cancer**: Their tumor must be **mismatch repair proficient (pMMR)** or not have a high level of **microsatellite instability (MSI-H)**, which are specific characteristics of the tumor.
For those with **second line colorectal cancer**: They must have been treated with only one previous therapy that included specific drugs like **fluoropyrimidine** and **oxaliplatin**, with or without other targeted therapies.
For those with **second line+ biliary tract cancer**: They must have a confirmed diagnosis of advanced or non-removable biliary tract cancer, which includes certain types of liver and gallbladder cancers.
For those with **second line+ biliary tract cancer**: They must have received one previous treatment with a drug called **gemcitabine** or two previous treatments, including gemcitabine and another type of therapy.
For those with **second line hepatocellular carcinoma**: They must have a confirmed diagnosis of liver cancer, but certain subtypes are not eligible.
Participants can be of any gender.
Participants must be adults, as the study includes age categories 3 and 4, which typically refer to adults.

Who cannot join the trial?

3 criteria

Patients with medical conditions other than Colorectal Carcinoma, Biliary Tract Carcinoma, or Hepatocellular Carcinoma cannot participate. These are types of cancer affecting the colon, bile ducts, and liver, respectively.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population, which means groups that may need special protection, are not eligible for this study.

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Verified sites

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

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ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
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CHU Croix Rousse-Lyon
Lyon, France
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Centre De Lutte Contre Le Cancer Eugene Marquis
Rennes, France

Trial locations

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Investigated drugs

Patritumab Deruxtecan is a medication being studied for its safety and effectiveness in treating gastrointestinal cancers. It is designed to target and deliver cancer-fighting agents directly to cancer cells, potentially reducing the growth of tumors. This medication is part of a clinical trial to understand how well it works and how safe it is for patients with these types of cancers.

Patritumab Deruxtecan

What is already known about the treatment

Patritumab Deruxtecan – This medication is administered intravenously and is currently being studied in clinical trials for its safety and effectiveness in treating certain gastrointestinal cancers, including colorectal, biliary tract, and hepatocellular carcinoma. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication is for cancers that express the HER3 protein. Patritumab Deruxtecan works by targeting the HER3 receptor on cancer cells, delivering a cytotoxic agent directly to the cells, which helps to inhibit their growth and survival. It is classified as an antibody-drug conjugate, combining a monoclonal antibody with a chemotherapy drug to enhance its cancer-fighting capabilities.

Investigated diseases

Colorectal Carcinoma
This is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, benign clumps of cells called polyps, which can develop into cancer over time. As the disease progresses, it can invade deeper layers of the colon or rectum and spread to nearby lymph nodes or other organs. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort.
Biliary Tract Carcinoma
This cancer affects the bile ducts, which are tubes that carry bile from the liver to the gallbladder and small intestine. It can develop in any part of the bile duct system and is often categorized based on its location. The disease may cause symptoms such as jaundice, itching, and abdominal pain as it progresses. It can spread to nearby tissues and organs, complicating its course.
Hepatocellular Carcinoma
This is the most common type of primary liver cancer, originating in the liver cells called hepatocytes. It often occurs in the context of chronic liver disease, such as cirrhosis or hepatitis. As the cancer grows, it can disrupt liver function and may spread to other parts of the body. Symptoms might include weight loss, upper abdominal pain, and jaundice.