Recruiting

Study of Ginisortamab with Nab-Paclitaxel and Gemcitabine or MEK Inhibitor for Patients with Metastatic Pancreatic 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 a type of cancer called metastatic pancreatic ductal adenocarcinoma. This is a form of pancreatic cancer that has spread to other parts of the body. The trial will investigate a new treatment called ginisortamab, which is given through an injection into a vein. Ginisortamab is also known by its code name, UCB6114, and is a type of protein designed to target specific cancer cells.

The purpose of the study is to evaluate the safety and effectiveness of ginisortamab in combination with other treatments. In the first part of the study, participants will receive ginisortamab along with standard cancer treatments, nab-paclitaxel and gemcitabine, which are commonly used chemotherapy drugs. In the second part, ginisortamab will be combined with a MEK inhibitor, a type of medication that helps prevent cancer cells from growing, as a maintenance therapy for those who have responded well to initial treatment.

Participants in the study will receive these treatments over a period of time, and researchers will monitor them to assess the safety of ginisortamab and its ability to control the cancer. The study aims to find the best dose of ginisortamab and to observe any potential anti-cancer effects. The trial will help determine if ginisortamab can be a beneficial addition to existing treatment options for this type of cancer.

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
Joining the trial
Upon joining the trial, you will provide written consent, confirming your willingness to participate and cooperate with the treatment and follow-up procedures.
You will undergo initial assessments to confirm your diagnosis of metastatic pancreatic ductal adenocarcinoma and ensure you meet the eligibility criteria.
Step 2
Initial treatment phase
In the first phase, you will receive ginisortamab intravenously, along with standard chemotherapy drugs, nab-paclitaxel and gemcitabine.
The dosage and frequency of these medications will be determined by the study team based on safety and effectiveness assessments.
Step 3
Monitoring and assessments
Throughout the trial, regular monitoring will occur to assess the safety and effectiveness of the treatment.
You will undergo various tests and scans to evaluate the response of your cancer to the treatment.
Step 4
Maintenance therapy
If your cancer shows a positive response or stabilizes after at least 16 weeks of initial treatment, you may receive ginisortamab in combination with a MEK inhibitor as maintenance therapy.
The study team will determine the appropriate dosage and schedule for this phase.
Step 5
Follow-up
After completing the treatment phases, follow-up visits will be scheduled to monitor your health and any long-term effects of the treatment.
These visits will help gather important data on the overall impact of the trial medications.

Who can join the trial?

7 criteria

Provide a signed and dated consent form, showing you agree to participate and can follow the study procedures.
Have a confirmed diagnosis of **metastatic pancreatic ductal adenocarcinoma** (PDAC), which means the cancer has spread from the pancreas to other parts of the body.
Agree to provide tumor samples before and during treatment for research purposes. These samples help study specific markers like **SMAD4** and **gremlin-1**. If you have only one measurable tumor, it should not be used for these samples, and special permission is needed.
Have at least one measurable tumor that can be tracked during the study, according to specific guidelines (RECIST Version 1.1). This tumor should not have been treated with radiation unless it has grown since then.
Have an **ECOG performance status** of 0 or 1, which means you are fully active or have some symptoms but can still do light work. This will be checked before starting the study treatment.
Have blood and other health tests within certain normal ranges to ensure it is safe for you to participate.
Be 18 years of age or older at the time you give consent to join the study.

Who cannot join the trial?

12 criteria

Patients with other types of cancer that have spread to other parts of the body (metastatic cancer) cannot participate.
Patients who have had a different cancer treatment within the last 4 weeks are not eligible.
Patients with severe heart problems are excluded.
Patients with uncontrolled infections cannot join the study.
Patients who are pregnant or breastfeeding are not allowed to participate.
Patients with known allergies to the study drugs or similar drugs cannot take part.
Patients with a history of severe allergic reactions to any medication are excluded.
Patients with certain blood disorders are not eligible.
Patients with severe liver or kidney disease cannot participate.
Patients who have received another investigational drug within the last 4 weeks are not eligible.
Patients with a history of drug or alcohol abuse within the last 6 months are excluded.
Patients with any other medical condition that the study doctors think would make it unsafe for them to participate are not eligible.

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Verified sites

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

Hospital Universitario Fundacion Jimenez Diaz
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Madrid, Spain
Hospital Vall d’Hebron
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Barcelona, Spain
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Verified
Ulm, Germany

Trial locations

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Investigated drugs

Ginisortamab
is an experimental medication being tested in this clinical trial. It is given to patients through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The purpose of this medication is to help treat metastatic pancreatic ductal adenocarcinoma, a type of cancer that has spread from the pancreas to other parts of the body. In this trial, researchers are studying how safe ginisortamab is for patients and how well it works to fight cancer when used with other treatments.
Nab-paclitaxel
is a medication used in this trial as part of the standard treatment for pancreatic cancer. It is a type of chemotherapy that helps stop cancer cells from growing and spreading. Nab-paclitaxel is given to patients through an intravenous infusion. In this study, it is used in combination with ginisortamab to see if the two medications together can be more effective in treating cancer.
Gemcitabine
is another chemotherapy medication used in this trial as part of the standard treatment for pancreatic cancer. Like nab-paclitaxel, it is given through an intravenous infusion and works by interfering with the growth of cancer cells. The trial is testing how well gemcitabine works with ginisortamab to treat cancer and whether this combination is safe for patients.
MEK inhibitor
is a type of medication used in this trial as a maintenance therapy. Maintenance therapy is a treatment given to help keep cancer from coming back after it has responded to initial treatment. MEK inhibitors work by blocking certain proteins that help cancer cells grow. In this study, the MEK inhibitor is combined with ginisortamab to see if this combination can help maintain the positive effects of the initial cancer treatment.

What is already known about the treatment

Ginisortamab – Ginisortamab is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials for its use in treating metastatic pancreatic ductal adenocarcinoma, a type of advanced pancreatic cancer. The main purpose of this medication is to work alongside standard chemotherapy drugs like nab-paclitaxel and gemcitabine, or with a MEK inhibitor for maintenance therapy, to help control cancer growth. At the molecular level, ginisortamab is designed to target specific cancer cells, potentially slowing their growth or causing them to die. It falls under the pharmacological classification of targeted cancer therapies, which aim to attack cancer cells more precisely than traditional chemotherapy.

Investigated diseases

Metastatic pancreatic ductal adenocarcinoma – This is a type of cancer that begins in the ducts of the pancreas and has spread to other parts of the body. It typically starts in the cells lining the pancreatic ducts, which are responsible for transporting digestive enzymes. As the disease progresses, cancer cells invade nearby tissues and organs, such as the liver and lungs. The spread of cancer cells to distant sites is known as metastasis, which can lead to the formation of new tumors in these areas. The progression of this disease can cause symptoms such as abdominal pain, weight loss, and jaundice. Over time, the disease can affect the body's ability to digest food and regulate blood sugar levels.