Recruiting

Study on the Safety and Effectiveness of MK-2870 Alone or with Other Drugs for Patients with Colorectal, Pancreatic, and Biliary Tract Cancers

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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, pancreatic ductal adenocarcinoma, and biliary tract cancer. The study will evaluate a new treatment called MK-2870, which is a type of medication known as a humanised IgG1 monoclonal antibody. This treatment will be tested both on its own and in combination with other cancer-fighting drugs to see how safe and effective it is for patients with these cancers.

The purpose of the study is to understand how well MK-2870 works and how patients tolerate it. Participants will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor participants for any side effects and how their cancer responds to the treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

Throughout the study, researchers will keep track of how long the treatment works, how long patients live without the cancer getting worse, and overall survival rates. The study aims to provide valuable information that could lead to better treatment options for people with these types of cancers. The trial is expected to continue until 2026, with recruitment starting in 2024.

The research process

The trial runs in 4 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 verifying the type of cancer, such as colorectal cancer, pancreatic ductal adenocarcinoma, or biliary tract cancer.
The assessment ensures that previous treatments have been completed and any side effects have resolved.
Step 2
Treatment phase
The treatment phase involves receiving MK-2870 either as a standalone treatment or in combination with other anticancer agents.
The administration of MK-2870 is through intravenous infusion. The frequency and dosage are determined based on individual response and tolerance.
Step 3
Monitoring and evaluation
Regular monitoring is conducted to evaluate safety and tolerability. This includes checking for any dose-limiting toxicities or adverse events.
The response to treatment is assessed using criteria known as RECIST 1.1, which helps in measuring the size of tumors and determining the effectiveness of the treatment.
Step 4
Follow-up
After completing the treatment phase, follow-up assessments are conducted to monitor the duration of response and overall survival.
Progression-free survival is also evaluated to determine the time during which the cancer does not worsen.

Who can join the trial?

6 criteria

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The patient must have one of the following types of cancer:
- Unresectable or metastatic colorectal cancer (cancer that cannot be removed by surgery or has spread to other parts of the body)
- Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) (a type of pancreatic cancer that is in a late stage or has spread)
- Advanced and/or unresectable biliary tract cancer (BTC) (a type of cancer in the bile ducts that is in a late stage or cannot be removed by surgery)
- The patient must have received one previous treatment for colorectal cancer or PDAC, or one or two previous treatments for BTC.
- The patient must have recovered from any side effects caused by previous cancer treatment.
- The study is open to both male and female patients.

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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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Fondazione I.R.C.C.S. Istituto Neurologico Besta
Milan, Italy
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy

Trial locations

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Investigated drugs

MK-2870 is an investigational medication being studied for its potential to treat gastrointestinal cancers. It is being tested both as a standalone treatment and in combination with other anticancer agents. The main goal of the study is to assess the safety and effectiveness of MK-2870 in shrinking tumors or stopping their growth.

Sacituzumab Tirumotecan

What is already known about the treatment

MK-2870 – This medication is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its safety and effectiveness in treating gastrointestinal cancers, including colorectal cancer, pancreatic ductal adenocarcinoma, and biliary tract cancer. MK-2870 works by targeting specific proteins involved in cancer cell growth, aiming to inhibit their function and slow down or stop the progression of the disease. It is classified as an anticancer agent, and its development is focused on improving outcomes for patients with these types of cancers.

Investigated diseases

Colorectal Cancer
This is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, noncancerous clumps of cells called polyps that can develop into cancer over time. As the disease progresses, it can invade nearby tissues and spread to other parts of the body. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression can vary, with some cases remaining localized while others spread more aggressively.
Pancreatic Ductal Adenocarcinoma
This is a common type of pancreatic cancer that originates in the ducts of the pancreas. It tends to grow and spread quickly, often reaching nearby organs and distant sites in the body. Early stages may not show symptoms, but as it progresses, it can cause jaundice, weight loss, and abdominal pain. The disease can obstruct the bile duct, leading to digestive issues. Its progression is often aggressive, making early detection challenging.
Biliary Tract Cancer
This cancer affects the bile ducts, which are responsible for carrying bile from the liver to the small intestine. It can develop in any part of the bile duct system and may cause symptoms like jaundice, itching, and abdominal pain as it progresses. The disease can obstruct bile flow, leading to liver damage and digestive problems. It often spreads to nearby organs and tissues, complicating its progression.