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Study of Zolbetuximab with Nab-Paclitaxel and Gemcitabine for Adults with Metastatic Pancreatic Cancer

Verified siteRegistered drugNo 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 metastatic pancreatic adenocarcinoma. This is a form of pancreatic cancer that has spread to other parts of the body. The study is investigating a treatment that combines a new medication called zolbetuximab with two existing chemotherapy drugs, nab-paclitaxel and gemcitabine. Zolbetuximab is a protein-based drug that is being tested to see if it can help improve the effectiveness of the chemotherapy drugs in treating this type of cancer.

The purpose of the study is to determine if the combination of zolbetuximab with nab-paclitaxel and gemcitabine can help patients live longer compared to using nab-paclitaxel and gemcitabine alone. The study will also look at how safe and tolerable the new treatment is for patients. Participants in the study will be randomly assigned to receive either the new combination treatment or the standard chemotherapy treatment. The study will monitor the participants' health and response to the treatment over a period of time.

Throughout the study, participants will receive the treatment through an intravenous infusion, which means the medication will be given directly into a vein. The study will also involve regular check-ups and tests to monitor the participants' health and the effects of the treatment. The goal is to gather information that could lead to better treatment options for people with metastatic pancreatic adenocarcinoma in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will provide informed consent, confirming understanding of the study's purpose and procedures.

    The patient will undergo initial assessments to confirm eligibility, including a review of medical history and current health status.

  2. Step 2

    Safety lead-in phase

    The patient will receive a combination of zolbetuximab, nab-paclitaxel, and gemcitabine to determine the recommended dose.

    Zolbetuximab is administered intravenously as a solution prepared from a powder.

    The patient's response to the medication will be monitored closely to assess safety and tolerability.

  3. Step 3

    Randomization phase

    The patient will be randomly assigned to receive either the combination of zolbetuximab, nab-paclitaxel, and gemcitabine or nab-paclitaxel and gemcitabine alone.

    The goal is to evaluate if the addition of zolbetuximab improves overall survival compared to the standard treatment.

  4. Step 4

    Treatment administration

    The patient will receive the assigned treatment regimen on a regular schedule, typically involving cycles of administration followed by rest periods.

    The specific dosage and frequency will be determined by the study protocol and the patient's response to treatment.

  5. Step 5

    Monitoring and assessments

    Throughout the study, the patient will undergo regular assessments to monitor health status, including blood tests, imaging studies, and physical examinations.

    These assessments will help evaluate the effectiveness of the treatment and any potential side effects.

  6. Step 6

    End of treatment

    Upon completion of the treatment phase, the patient will undergo final assessments to determine the overall impact of the treatment.

    The patient will be informed of the study's findings and any further steps, if applicable.

Who can join the trial?

12 criteria

  • You must provide written consent to participate, which means you agree to join the study after understanding all the details.
  • You must have a confirmed diagnosis of pancreatic adenocarcinoma, a type of cancer that starts in the pancreas.
  • Your cancer must have spread to other parts of the body and not have been treated with chemotherapy before.
  • You must have at least one measurable tumor that can be seen on a scan.
  • Your tumor must show a specific protein called **CLDN18.2** in a high percentage of the cancer cells.
  • You must be able to perform daily activities with little or no assistance, as measured by a scale called **ECOG performance status**.
  • You must have a life expectancy of at least 12 weeks, as estimated by the doctor.
  • Your blood tests must meet certain criteria, such as having enough red and white blood cells and normal liver and kidney function.
  • You must be considered an adult according to local laws.
  • You must agree not to join another study while participating in this one.
  • If you are a woman, you must not be pregnant or breastfeeding and agree to use birth control if you can have children.
  • If you are a man, you must agree to use birth control if your partner can have children and not donate sperm during the study.
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Investigated drugs

  • Zolbetuximab

    is an experimental medication being tested for its effectiveness and safety in treating a specific type of pancreatic cancer. It is used in combination with other cancer treatments to see if it can help improve survival rates in patients with this condition.

  • Nab-Paclitaxel

    is a chemotherapy drug used to treat various types of cancer, including pancreatic cancer. It works by stopping the growth of cancer cells and is often used in combination with other medications to enhance its effectiveness.

  • Gemcitabine

    is another chemotherapy medication that is commonly used to treat pancreatic cancer. It helps to slow or stop the growth of cancer cells and is often used alongside other treatments to improve outcomes for patients.

What is already known about the treatment

Zolbetuximab – Zolbetuximab is administered intravenously and is currently being studied in clinical trials as a treatment for metastatic pancreatic adenocarcinoma that is positive for Claudin 18.2. It is in the investigational stage, with ongoing research to confirm its effectiveness and safety. The main therapeutic indication is as a first-line treatment for this specific type of cancer. Zolbetuximab works by targeting the Claudin 18.2 protein on cancer cells, potentially inhibiting tumor growth. It is classified as a monoclonal antibody, which is a type of targeted cancer therapy.

Investigated diseases

Metastatic Pancreatic Adenocarcinoma – This is a type of cancer that begins in the tissues of the pancreas and has spread to other parts of the body. It is characterized by the uncontrolled growth of cells in the pancreas, which can invade nearby tissues and organs. As the disease progresses, it can cause symptoms such as abdominal pain, weight loss, and jaundice. The cancer cells can travel through the bloodstream or lymphatic system to form new tumors in other organs. This condition is often diagnosed at an advanced stage due to its subtle early symptoms. The presence of Claudin 18.2 (CLDN18.2) is a specific marker that can be found in some cases of this cancer.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510985-17-00Protocol code8951-CL-5201Estimated enrolment396 patientsSponsorAstellas Pharma Global Development Inc.

sourced from the EU Clinical Trials Register and site verification

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