Study on PBP1510 and Gemcitabine for Patients with Advanced Pancreatic Cancer After Previous Chemotherapy

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What is this study about?

This clinical trial is focused on studying a treatment for pancreatic cancer, specifically in patients with advanced or metastatic forms of the disease. The treatment being tested is a new medication called PBP1510, which is a type of protein known as a humanized immunoglobulin G1 (IgG1) kappa monoclonal antibody. This medication targets a specific factor associated with pancreatic cancer. The study will also involve the use of another medication called gemcitabine, which is commonly used in cancer treatment.

The purpose of this study is to evaluate the safety and effectiveness of PBP1510 when given alone and in combination with gemcitabine. The study is divided into two parts. In the first part, the focus is on understanding how safe and tolerable PBP1510 is for patients. In the second part, the study aims to determine how effective the treatment is when used with gemcitabine. Patients participating in the study will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein.

Throughout the study, patients will be monitored for any side effects and how their bodies respond to the treatment. The study will also look at how the treatment affects the cancer and whether it helps in reducing the size of the tumors. This research is important for developing new treatment options for patients with pancreatic cancer who have not responded to previous chemotherapy treatments.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

A physical examination and laboratory tests are performed to ensure all criteria are met.

2 treatment phase 1

In Phase 1, the focus is on evaluating the safety and tolerability of the medication PBP1510, administered alone or with gemcitabine.

PBP1510 is given through an intravenous infusion. The dosage and frequency are determined by the study protocol.

Regular monitoring of health parameters, including blood tests and vital signs, is conducted to assess any side effects.

3 treatment phase 2a

In Phase 2a, the goal is to establish the safety and assess the efficacy of PBP1510 at the recommended dose, in combination with gemcitabine.

The treatment is administered through intravenous infusion, with the schedule based on the study protocol.

Health assessments continue, focusing on the response to treatment and any side effects.

4 ongoing monitoring

Throughout the study, regular visits are scheduled to monitor health status and treatment effects.

These visits include physical exams, laboratory tests, and imaging studies to evaluate the progression of the disease.

5 end of study

At the conclusion of the study, a final assessment is conducted to evaluate overall health and treatment outcomes.

Participants may receive guidance on future care and follow-up recommendations.

Who Can Join the Study?

Must be an adult, 18 years or older, or the legal age of majority in the country where the study is conducted.
Women who cannot have children must meet certain medical criteria, such as having had a hysterectomy (removal of the uterus) or being postmenopausal (no menstrual periods for at least 12 months).
Women who can have children must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for at least 6 months after the last dose of the study drug.
Men with partners who can have children must agree to use two effective forms of birth control during the study and for at least 6 months after the last dose of the study drug.
Must be willing and able to follow the study schedule, treatment plan, and other study requirements.
For Part 1 of the study, must have advanced or metastatic pancreatic cancer that has worsened after at least one previous chemotherapy treatment.
For Part 2 of the study, must have advanced or metastatic pancreatic cancer that has worsened after one previous chemotherapy treatment.
Must understand and voluntarily sign a consent form before any study-specific procedures are done.
Must have a Performance Status score of 1 or less, which means being able to carry out light activities.
Must have confirmed diagnosis of advanced or metastatic pancreatic cancer.
Must have a life expectancy of at least 3 months.
Must not have any other cancer that would interfere with the study treatment.
Previous radiation therapy is allowed if it was to less than 25% of the bone marrow and completed at least 4 weeks before starting the study treatment.
Must have at least one measurable tumor as per specific medical guidelines.
Must have adequate organ function, which includes specific levels of blood cells, liver function, kidney function, and heart function.

Who Cannot Join the Study?

Patients who have not received at least one previous line of chemotherapy for their pancreatic cancer.
Patients with other types of cancer that are not pancreatic adenocarcinoma.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who are not within the specified age range for the study.
Patients who have any medical condition that the study doctors think might make it unsafe for them to participate.
Patients who are unable to follow the study procedures or attend the required visits.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Hospital Unviersitario Miguel Servet	Zaragoza	Spain
Frckcphyd Pxrt Lb Izkkcavcrzxvo Bgkvjqbml Dgt Hcxnxbid Uwxrpcoatmnwq Lv Pcz	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	16.02.2022

Trial locations

Investigated drugs:

Anti-(Pancreatic Adenocarcinoma Upregulated Factor) Igg1 Humanised Monoclonal Antibody

PBP1510 is a new experimental medication being tested for its safety and effectiveness in treating patients with advanced or metastatic pancreatic cancer. It is being studied to see how well it can be tolerated by patients and how it behaves in the body when given alone or in combination with another cancer treatment.

Gemcitabine is a chemotherapy drug that is commonly used to treat various types of cancer, including pancreatic cancer. In this trial, it is used in combination with PBP1510 to see if the two medications together can provide better outcomes for patients whose cancer has progressed after previous treatments.

Investigated diseases:

Advanced and/or Metastatic Pancreatic Adenocarcinoma – This is a type of cancer that begins in the tissues of the pancreas, an organ in the abdomen that lies behind the lower part of the stomach. In its advanced stages, the cancer has spread beyond the pancreas to nearby tissues or organs, and in metastatic stages, it has spread to distant parts of the body. The disease often progresses silently, with symptoms appearing only after the cancer has grown or spread significantly. Common symptoms may include abdominal pain, weight loss, jaundice, and digestive problems. As the disease advances, it can affect the function of the pancreas and other organs, leading to more severe symptoms. The progression of the disease can vary, but it typically involves the growth and spread of cancerous cells, impacting the body’s ability to function normally.

Trial ID:

2024-514379-16-00

Protocol code:

PAUF-I

NCT ID:

NCT05141149

Trial Phase:

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

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Study on PBP1510 and Gemcitabine for Patients with Advanced Pancreatic Cancer After Previous Chemotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?