Study of RR001 with Gemcitabine and Paclitaxel for Patients with Locally Advanced Pancreatic Cancer

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What is this study about?

This clinical trial is focused on treating pancreatic cancer, specifically a type called locally advanced pancreatic adenocarcinoma, which cannot be removed by surgery. The study is testing a new treatment called RR001, which is a type of gene therapy. Gene therapy involves using cells that have been changed in a lab to help fight cancer. In this case, the cells are taken from the patient’s own body, modified to produce a special protein that can help kill cancer cells, and then injected directly into the tumor. This treatment is given along with standard chemotherapy drugs, Gemcitabine and Abraxane (also known as paclitaxel albumin-bound), which are commonly used to treat pancreatic cancer.

The purpose of the study is to find out if the new treatment is safe and to determine the best dose to use. Patients will receive the treatment through injections guided by ultrasound, a technique that uses sound waves to create images of the inside of the body. The study will start with a small dose of RR001 and gradually increase it to find the highest dose that can be given safely. The study will also look at how well the treatment works in shrinking the tumor and improving the patient’s quality of life.

Participants in the study will receive the treatment over a period of time and will be monitored closely by doctors. They will have regular check-ups, including imaging tests like CT scans to see how the tumor is responding to the treatment. The study will also track how long it takes for the disease to progress and how long patients live after receiving the treatment. The goal is to improve the outcomes for patients with this challenging type of cancer.

1 initial treatment phase

Upon joining the study, the patient will begin the initial treatment phase. This involves receiving a combination of chemotherapy drugs, including gemcitabine and paclitaxel albumin-bound. These medications are administered through a vein, a process known as intravenous administration.

The dosage and frequency of these medications will be determined by the medical team based on individual health conditions and response to treatment. The duration of this phase will be specified by the healthcare provider.

2 gene therapy administration

Following the initial treatment phase, the patient will receive a gene therapy product called RR001. This therapy involves injecting genetically modified cells directly into the tumor. This process is known as intratumoral use and is guided by ultrasound to ensure accuracy.

The goal of this phase is to determine the safety and effectiveness of the gene therapy when used in combination with the chemotherapy drugs. The medical team will monitor the patient closely to assess any side effects and the overall response to the treatment.

3 dose escalation

During the dose escalation phase, the patient will receive increasing doses of the gene therapy product RR001. This is done to establish the maximum dose that can be tolerated without significant side effects.

The medical team will carefully monitor the patient’s health and adjust the dosage as needed. This phase is crucial for determining the recommended dose for future studies.

4 ongoing monitoring and assessment

Throughout the trial, the patient’s health and response to treatment will be regularly monitored. This includes imaging procedures, laboratory tests, and assessments of tumor size and progression.

The medical team will evaluate the effectiveness of the treatment using specific criteria and will also assess the patient’s quality of life during the study.

5 completion of trial participation

At the end of the trial, the patient will undergo a final assessment to evaluate the overall impact of the treatment. This includes a review of all collected data and a discussion of the patient’s health status.

The results of the trial will contribute to the understanding of the treatment’s safety and effectiveness, potentially leading to further research and development.

Who Can Join the Study?

Patients must have a confirmed diagnosis of pancreatic ductal adenocarcinoma, which is a type of pancreatic cancer.
Patients must have adequate liver function, meaning their bilirubin levels should be less than 1.5 times the upper limit of normal (ULN), and AST and ALT levels should be less than 2.5 times the ULN.
Patients must have adequate kidney function, with serum creatinine less than 2 times the ULN or creatinine clearance greater than 30 mL/min.
Patients must have a certain level of blood cells: absolute neutrophil count (a type of white blood cell) of at least 1.0 x 10⁹/L, hemoglobin of at least 9 g/dL, and platelet count of at least 100 x 10⁹/L. The prothrombin time (a measure of blood clotting) should be less than 1.5.
Patients should have a life expectancy of at least 12 weeks.
Females of childbearing potential must have a negative pregnancy test before starting treatment.
Patients must be willing and able to follow the study schedule, including visits, treatment plans, imaging procedures, lab tests, and other study procedures.
Patients should have no evidence of cancer spread to the lining of the abdomen or through the bloodstream.
Patients must be classified as having non-resectable locally advanced pancreatic cancer based on imaging and evaluation by a team of specialists.
Patients must have a measurable tumor according to specific criteria (RECIST v 1.1).
Patients should have a low tumor burden, with at least one tumor lesion that is 3.5 cm or smaller and suitable for ultrasound-guided injection and needle biopsy.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, which indicates their level of functioning.
Patients must be eligible for standard treatment with GEM/Nab-PTX, which are chemotherapy drugs.
Patients must be older than 18 years of age.
Patients must provide a signed and dated informed consent form approved by an Ethics Committee, indicating they have been informed about the study.

Who Cannot Join the Study?

Patients with any other type of cancer that is not pancreatic adenocarcinoma cannot participate. Adenocarcinoma is a type of cancer that forms in mucus-secreting glands.
Patients who have had previous treatments that might interfere with the study.
Patients with severe or uncontrolled medical conditions that could affect their safety during the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who have allergies to the study medication or its components.
Patients who are participating in another clinical trial at the same time.
Patients with a history of drug or alcohol abuse that could interfere with the study.
Patients with certain infections that could affect their participation in the study.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	06.01.2025

Trial locations

Investigated drugs:

RR001 is a new treatment being tested in this study. It is given directly into the tumor using a special technique guided by ultrasound. The goal is to see if it is safe and can be used together with other standard treatments for pancreatic cancer. The study will also find out the best dose to use in future research.

Gemcitabine is a standard chemotherapy drug used to treat pancreatic cancer. It works by stopping cancer cells from growing and dividing. In this study, it is used along with other treatments to see if it can help improve the overall effectiveness of the therapy.

Nab-Paclitaxel is another chemotherapy drug that is often used with Gemcitabine to treat pancreatic cancer. It helps to kill cancer cells and slow down their growth. In this study, it is combined with other treatments to see if it can enhance the treatment’s success.

Investigated diseases:

Ductal adenocarcinoma of pancreas

Locally advanced, non-resectable pancreatic adenocarcinoma – This is a type of cancer that originates in the pancreas, specifically in the cells that line the ducts of the pancreas. It is termed “locally advanced” because the cancer has spread beyond the pancreas to nearby tissues or organs but not to distant parts of the body. The term “non-resectable” indicates that the tumor cannot be surgically removed due to its size, location, or involvement with vital blood vessels. As the disease progresses, it may cause symptoms such as abdominal pain, weight loss, and jaundice. The progression can lead to further complications as the tumor affects nearby organs and structures.

Ductal adenocarcinoma of pancreas – This is the most common type of pancreatic cancer, arising from the ductal cells of the pancreas. It typically begins in the ducts that carry digestive enzymes out of the pancreas. As the disease progresses, it can invade nearby tissues and organs, causing symptoms like abdominal pain, back pain, and digestive issues. The cancer may also spread to other parts of the body, such as the liver or lungs. Over time, the tumor can obstruct the bile duct, leading to jaundice. The progression of this disease can significantly impact the function of the pancreas and surrounding organs.

Trial ID:

2024-516019-26-00

Protocol code:

SNIPER

NCT ID:

NCT06861452

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of RR001 with Gemcitabine and Paclitaxel for Patients with Locally Advanced Pancreatic Cancer

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